## Protocol Section
### Identification Module
**NCT ID:** NCT02385279

**Acronym:** DESSOLVE III

**Brief Title:** Study Comparing the MiStent SES Versus the XIENCE EES Stent

**Official Title:** Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries

#### Organization Study ID Info
**ID:** ECRI-005
#### Organization
**Class:** INDUSTRY
**Full Name:** ECRI bv
### Status Module
#### Completion Date
**Date:** 2021-02-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-08

**Type:** ACTUAL

**Last Update Submit Date:** 2022-07-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-01-31

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-05-08

**Type:** ACTUAL

**Results First Submit Date:** 2021-12-08

**Results First Submit QC Date:** 2022-07-12

#### Start Date
**Date:** 2015-03-20

**Type:** ACTUAL

**Status Verified Date:** 2022-07

#### Study First Post Date
**Date:** 2015-03-11
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-17
**Study First Submit QC Date:** 2015-03-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Micell Technologies

**Class:** INDUSTRY

**Name:** Stentys

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** ECRI bv

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.

### Conditions Module

**Conditions:**

- Coronary Stenosis

**Keywords:**

- CAD

- ACS

- All comers

- PCI

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1398

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

**Intervention Names:**

- Device: MiStent

**Label:** MiStent®

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

**Intervention Names:**

- Device: XIENCE EES

**Label:** XIENCE EES

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MiStent®

**Description:** Percutaneous Coronary Intervention

**Name:** MiStent

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- XIENCE EES

**Description:** Percutaneous Coronary Intervention

**Name:** XIENCE EES

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization.

**Measure:** Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)

**Time Frame:** 12 months postprocedure

#### Secondary Outcomes

**Description:** POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization

**Measure:** POCE

**Time Frame:** At 12 months

**Description:** MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR)

**Measure:** MACE

**Time Frame:** At 12 months

**Description:** Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR

**Measure:** Target Vessel Failure (TVF)

**Time Frame:** At 12 months

**Description:** All-cause death

**Measure:** All-cause Death

**Time Frame:** At 12 months

**Description:** Any Myocardial infarction

**Measure:** Myocardial Infarction

**Time Frame:** At 12 months

**Description:** Any revascularization

**Measure:** Any Revascularization

**Time Frame:** At 12 months

**Description:** Definite or probably stent thrombosis according to ARC

**Measure:** Stent Thrombosis

**Time Frame:** At 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

All comers" patients:

* Male or female patients 18 years or older;
* Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
* The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria.
* The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Known pregnancy or breastfeeding at time of randomization;
* Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
* Concurrent medical condition with a life expectancy of less than 12 months.
* The patient is unwilling/ not able to return for outpatient clinic at 1 month and 12 months follow-up.
* Currently participating in another trial and not yet at its primary endpoint.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Corbeil

**Country:** France

**Facility:** Research Center Corbeil

**Location 2:**

**City:** Nimes

**Country:** France

**Facility:** Research Center Nimes

**Location 3:**

**City:** Poitiers

**Country:** France

**Facility:** Research Center Poitiers

**Location 4:**

**City:** Jena

**Country:** Germany

**Facility:** Research Center Jena

**Location 5:**

**City:** Leipzig

**Country:** Germany

**Facility:** Research Center Leipzig

**Location 6:**

**City:** Munster

**Country:** Germany

**Facility:** Research Center Munster

**Location 7:**

**City:** Ulm

**Country:** Germany

**Facility:** Research Center Ulm

**Location 8:**

**City:** Wiesbaden

**Country:** Germany

**Facility:** Research Center Wiesbaden

**Location 9:**

**City:** Amersfoort

**Country:** Netherlands

**Facility:** Research Center Amersfoort

**Location 10:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Research Center Amsterdam

**Location 11:**

**City:** Blaricum

**Country:** Netherlands

**Facility:** Tergooi

**Location 12:**

**City:** Emmen

**Country:** Netherlands

**Facility:** Research Center Emmen

**Location 13:**

**City:** Leeuwarden

**Country:** Netherlands

**Facility:** Research Center Leeuwarden

**Location 14:**

**City:** Nijmegen

**Country:** Netherlands

**Facility:** Research Center Nijmegen

**Location 15:**

**City:** Venlo

**Country:** Netherlands

**Facility:** Research Center Venlo

**Location 16:**

**City:** Belchatow

**Country:** Poland

**Facility:** Research Center Belchatow

**Location 17:**

**City:** Bielsko-Biala

**Country:** Poland

**Facility:** Research Center Bielsko-Biala

**Location 18:**

**City:** Chrzanow

**Country:** Poland

**Facility:** Research center Chrzanow

**Location 19:**

**City:** Tychy

**Country:** Poland

**Facility:** Research Center Tychy

**Location 20:**

**City:** Zgierz

**Country:** Poland

**Facility:** Research Center Zgierz

#### Overall Officials

**Official 1:**

**Affiliation:** European Cardiovascular Research Institute

**Name:** Ernest Spitzer, MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** de Winter RJ, Katagiri Y, Asano T, Milewski KP, Lurz P, Buszman P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Ophuis TO, Wohrle J, Wyderka R, Cayla G, Hofma SH, Levesque S, Zurakowski A, Fischer D, Kosmider M, Goube P, Arkenbout EK, Noutsias M, Ferrari MW, Onuma Y, Wijns W, Serruys PW. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet. 2018 Feb 3;391(10119):431-440. doi: 10.1016/S0140-6736(17)33103-3. Epub 2017 Dec 5.

**PMID:** 29203070

**Citation:** Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20.

**PMID:** 34666500

**Citation:** Katagiri Y, Andreini D, Miyazaki Y, Takahashi K, Komiyama H, Mushtaq S, Sonck J, Schoors D, Maisano F, Kaufman PA, Leal I, Lindeboom W, Piek JJ, Wykrzykowska JJ, Morel MA, Bartorelli AL, Onuma Y, Serruys PW; SYNTAX III REVOLUTION Investigators. Site vs. core laboratory variability in computed tomographic angiography-derived SYNTAX scores in the SYNTAX III trial. Eur Heart J Cardiovasc Imaging. 2021 Aug 14;22(9):1063-1071. doi: 10.1093/ehjci/jeaa172.

**PMID:** 32888011

**Citation:** Takahashi K, Serruys PW, Kogame N, Buszman P, Lurz P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Oude Ophuis T, Milewski KP, Hofma SH, Wykrzykowska JJ, Onuma Y, de Winter RJ, Wijns W. Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008737. doi: 10.1161/CIRCINTERVENTIONS.119.008737. Epub 2020 May 29.

**PMID:** 32466676

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-03-07

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 568483

- Type Abbrev: Prot_SAP

- Upload Date: 2021-12-08T05:05

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M22913

- Name: Coronary Stenosis

- Relevance: HIGH

- As Found: Coronary Stenosis

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000023921

- Term: Coronary Stenosis

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M255

- Name: Everolimus

- Relevance: LOW

- As Found: Unknown

- ID: M21960

- Name: Sirolimus

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Adverse event reporting in the context of a post-marketing trial.

#### Event Groups

**Group ID:** EG000

**Title:** MiStent®

**Deaths Num Affected:** 85

**Deaths Num At Risk:** 703

**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention

**ID:** EG000

**Other Num Affected:** 76

**Other Num at Risk:** 703

**Serious Number Affected:** 434

**Serious Number At Risk:** 703

**Title:** MiStent®

**Group ID:** EG001

**Title:** XIENCE EES

**Deaths Num Affected:** 78

**Deaths Num At Risk:** 695

**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention

**ID:** EG001

**Other Num Affected:** 71

**Other Num at Risk:** 695

**Serious Number Affected:** 426

**Serious Number At Risk:** 695

**Title:** XIENCE EES

**Frequency Threshold:** 0

#### Other Events

**Term:** Non Serious AE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MEDDEV 2.7/3

#### Serious Events

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MEDDEV 2.7/3

##### Stats

**Group ID:** EG000

**Num Affected:** 17

**Num At Risk:** 703

**Group ID:** EG001

**Num Affected:** 15

**Num At Risk:** 695

**Term:** Definite stent thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MEDDEV 2.7/3

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 703

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 695

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MEDDEV 2.7/3

##### Stats

**Group ID:** EG000

**Num Affected:** 414

**Num At Risk:** 703

**Group ID:** EG001

**Num Affected:** 406

**Num At Risk:** 695

**Time Frame:** 12 months (primary reporting), and yearly up to 5 years.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 703

**Group ID:** BG001

**Value:** 695

**Group ID:** BG002

**Value:** 1398

**Units:** Participants

### Group

**ID:** BG000

**Title:** MiStent®

**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention

### Group

**ID:** BG001

**Title:** XIENCE EES

**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 257

#### Measurement

**Group ID:** BG001

**Value:** 271

#### Measurement

**Group ID:** BG002

**Value:** 528

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 446

#### Measurement

**Group ID:** BG001

**Value:** 424

#### Measurement

**Group ID:** BG002

**Value:** 870

**Category Title:** >=65 years

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 703

**Group ID:** BG001

**Value:** 695

**Group ID:** BG002

**Value:** 1398

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.7

**Value:** 66.4

#### Measurement

**Group ID:** BG001

**Spread:** 10.7

**Value:** 66.3

#### Measurement

**Group ID:** BG002

**Spread:** 10.7

**Value:** 66.4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 703

**Group ID:** BG001

**Value:** 695

**Group ID:** BG002

**Value:** 1398

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 209

#### Measurement

**Group ID:** BG001

**Value:** 182

#### Measurement

**Group ID:** BG002

**Value:** 391

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 494

#### Measurement

**Group ID:** BG001

**Value:** 513

#### Measurement

**Group ID:** BG002

**Value:** 1007

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 703

**Group ID:** BG001

**Value:** 695

**Group ID:** BG002

**Value:** 1398

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 297

#### Measurement

**Group ID:** BG001

**Value:** 296

#### Measurement

**Group ID:** BG002

**Value:** 593

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 703

**Group ID:** BG001

**Value:** 695

**Group ID:** BG002

**Value:** 1398

**Class Title:** Netherlands

#### Measurement

**Group ID:** BG000

**Value:** 187

#### Measurement

**Group ID:** BG001

**Value:** 184

#### Measurement

**Group ID:** BG002

**Value:** 371

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 703

**Group ID:** BG001

**Value:** 695

**Group ID:** BG002

**Value:** 1398

**Class Title:** Poland

#### Measurement

**Group ID:** BG000

**Value:** 56

#### Measurement

**Group ID:** BG001

**Value:** 56

#### Measurement

**Group ID:** BG002

**Value:** 112

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 703

**Group ID:** BG001

**Value:** 695

**Group ID:** BG002

**Value:** 1398

**Class Title:** France

#### Measurement

**Group ID:** BG000

**Value:** 163

#### Measurement

**Group ID:** BG001

**Value:** 159

#### Measurement

**Group ID:** BG002

**Value:** 322

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 703

**Group ID:** BG001

**Value:** 695

**Group ID:** BG002

**Value:** 1398

**Class Title:** Germany

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restrictive Agreement:** True
### Point of Contact
**Email:** E.Spitzer@ECRI-Trials.com
**Organization:** European Cardiovascular Research Institute
**Phone:** +31102062828
**Title:** Dr. E. Spitzer
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 101
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Intention-to-treat
**Reporting Status:** POSTED
**Time Frame:** 12 months postprocedure
**Title:** Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention
**ID:** OG000
**Title:** MiStent®
##### Group
**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention
**ID:** OG001
**Title:** XIENCE EES
#### Outcome Measure 2
**Description:** POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** ITT
**Reporting Status:** POSTED
**Time Frame:** At 12 months
**Title:** POCE
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention
**ID:** OG000
**Title:** MiStent®
##### Group
**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention
**ID:** OG001
**Title:** XIENCE EES
#### Outcome Measure 3
**Description:** MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR)
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** At 12 months
**Title:** MACE
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention
**ID:** OG000
**Title:** MiStent®
##### Group
**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention
**ID:** OG001
**Title:** XIENCE EES
#### Outcome Measure 4
**Description:** Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** ITT
**Reporting Status:** POSTED
**Time Frame:** At 12 months
**Title:** Target Vessel Failure (TVF)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention
**ID:** OG000
**Title:** MiStent®
##### Group
**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention
**ID:** OG001
**Title:** XIENCE EES
#### Outcome Measure 5
**Description:** All-cause death
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** ITT
**Reporting Status:** POSTED
**Time Frame:** At 12 months
**Title:** All-cause Death
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention
**ID:** OG000
**Title:** MiStent®
##### Group
**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention
**ID:** OG001
**Title:** XIENCE EES
#### Outcome Measure 6
**Description:** Any Myocardial infarction
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** At 12 months
**Title:** Myocardial Infarction
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention
**ID:** OG000
**Title:** MiStent®
##### Group
**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention
**ID:** OG001
**Title:** XIENCE EES
#### Outcome Measure 7
**Description:** Any revascularization
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** At 12 months
**Title:** Any Revascularization
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention
**ID:** OG000
**Title:** MiStent®
##### Group
**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention
**ID:** OG001
**Title:** XIENCE EES
#### Outcome Measure 8
**Description:** Definite or probably stent thrombosis according to ARC
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** At 12 months
**Title:** Stent Thrombosis
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention
**ID:** OG000
**Title:** MiStent®
##### Group
**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention
**ID:** OG001
**Title:** XIENCE EES
### Participant Flow Module
#### Group
**Description:** Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating.

MiStent: Percutaneous Coronary Intervention
**ID:** FG000
**Title:** MiStent®
#### Group
**Description:** Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

XIENCE EES: Percutaneous Coronary Intervention
**ID:** FG001
**Title:** XIENCE EES
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 703
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 695
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 676
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 677
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 27
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 18
**Has Results:** True