## Protocol Section
### Identification Module
**NCT ID:** NCT01024179

**Brief Title:** Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

**Official Title:** Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns After Sirolimus-eluting Stent Implantation Assessment by Optical Coherence Tomography

#### Organization Study ID Info
**ID:** HMUOCT-PLAQUE
#### Organization
**Class:** OTHER
**Full Name:** Harbin Medical University
### Status Module
#### Completion Date
**Date:** 2011-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2009-12-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-12-04

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2010-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2009-12

**Status Verified Date:** 2009-12

#### Study First Post Date
**Date:** 2009-12-02
**Type:** ESTIMATED
**Study First Submit Date:** 2009-12-01
**Study First Submit QC Date:** 2009-12-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Harbin Medical University

#### Responsible Party

**Old Name Title:** Bo Yu

**Old Organization:** Department of Cardiology of The Second Affiliated Hospital of Harbin Medical University

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP. These findings imply that initial native lesion characteristics may be related to different vessel response (neointimal coverage and malapposition) after stenting. However, there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT.

Therefore, this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation. The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting, 6 months and 12 months. IVUS will also be performed to evaluate the tissue protrusion, malapposition, vessel remodeling at the same time points.

### Conditions Module

**Conditions:**

- Coronary Artery Disease

**Keywords:**

- Optical Coherence Tomography

- Coronary artery disease

- Chronic total occlusion

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Chronic total occlusion

**Intervention Names:**

- Device: Polymer-based sirolimus-eluting stent (Partner stent )

**Label:** Group B: CTO

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Non-chronic total occlusion :

1. Fibrous plaque+fibro-calcific plaque + Lipid plaque(\<2 quadrants )
2. Lipid-rich plaque ( ≥2 quadrants )

**Intervention Names:**

- Device: Polymer-based sirolimus-eluting stent (Partner stent )

**Label:** Group A : Non-CTO

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A : Non-CTO

- Group B: CTO

**Description:** Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery

**Name:** Polymer-based sirolimus-eluting stent (Partner stent )

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.

**Time Frame:** 6 months

#### Secondary Outcomes

**Measure:** Relationship between tissue prolapse and initial plaque characteristics

**Time Frame:** Post-intervention

**Measure:** Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.

**Time Frame:** 6-month

**Measure:** Late stent malapposition( by OCT and IVUS ).

**Time Frame:** 6 months

**Measure:** Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.

**Time Frame:** 12 -month

**Measure:** Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

General Inclusion Criteria：

1. Age:18-75Y
2. Patients with stable angina or acute coronary syndrome considered suitable for coronary revascularization.
3. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.

Angiographic Inclusion Criteria：

1. Significant coronary de novo lesion (\> 70% by visual estimation).
2. Target lesion is de novo native coronary artery lesion that can be treated with 1-2 stents.
3. Reference vessel diameter of 2.5 to 4.0 mm.

Exclusion Criteria：

General Exclusion Criteria：

1. ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
2. Previous CABG.
3. Life expectancy \<12 months due to another medical condition.
4. Contraindication to antiplatelet therapy
5. Creatinine level more than 2.0mg/dL or ESRD.
6. Severe hepatic dysfunction (more than 3 times normal reference values).
7. Planned surgery procedure ≤ 6 months post-index procedure.
8. Known allergy to stainless steel or a history of hypersensitivity to sirolimus or structurally related compounds.
9. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
10. Patient is not clinically appropriate for OCT evaluation in the opinion of the investigator.

Angiographic Exclusion Criteria：

1. Study lesion is ostial in location (within 3.0 mm of vessel origin).
2. Study lesion involving arterial segments with highly tortuous anatomy.
3. Complex lesion morphologies (aorto-ostial, bifurcation needs two stents technique, left main, severe thrombi, heavy calcification).

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yubodr@163.com

**Name:** Bo Yu, MD,PhD

**Phone:** 86-0451-86605180

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Harbin

**Contacts:**

***Contact 1:***

- **Email:** yubodr@163.com

- **Name:** Bo Yu, MD.PhD

- **Phone:** 86-0451-86605180

- **Role:** CONTACT

***Contact 2:***

- **Name:** Bo Yu, MD,PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** The second Affiliated Hospital of Harbin Medical University

**State:** Heilong jiang

**Status:** RECRUITING

**Zip:** 150081

#### Overall Officials

**Official 1:**

**Affiliation:** The Second Affiliated Hospital of Harbin Medical University

**Name:** Bo Yu, MD.PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003327

- Term: Coronary Disease

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000935

- Term: Antifungal Agents

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21960

- Name: Sirolimus

- Relevance: HIGH

- As Found: Included

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M6252

- Name: Clotrimazole

- Relevance: LOW

- As Found: Unknown

- ID: M11796

- Name: Miconazole

- Relevance: LOW

- As Found: Unknown

- ID: M4254

- Name: Antifungal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000020123

- Term: Sirolimus

### Misc Info Module

- Version Holder: 2024-05-24
