## Protocol Section
### Identification Module
**NCT ID:** NCT00233779

**Brief Title:** Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)

**Official Title:** Sirolimus-Eluting, Heparin-Coated Cobalt Chromium Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions in Small Vessels (EVOLUTION)

#### Organization Study ID Info
**ID:** P03-7401
#### Organization
**Class:** INDUSTRY
**Full Name:** Cordis Corporation
### Status Module
#### Completion Date
**Date:** 2004-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2007-06-27

**Type:** ESTIMATED

**Last Update Submit Date:** 2007-06-26

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2003-10

**Status Verified Date:** 2007-06

#### Study First Post Date
**Date:** 2005-10-06
**Type:** ESTIMATED
**Study First Submit Date:** 2005-10-04
**Study First Submit QC Date:** 2005-10-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Cordis Corporation

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objective of this study is to assess the performance and safety of a sirolimus-eluting, heparin-coated, cobalt chromium balloon-expandable stent (Small Vessel Stent) in patients with de novo native coronary artery lesions in small vessels as compared to historical data from small vessel patients in the RAVEL trial receiving the Sirolimus-eluting Bx VELOCITY™ stent.

### Conditions Module

**Conditions:**

- Coronary Artery Disease

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 52

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENT

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** The primary endpoint is in-stent late loss as measured by quantitative coronary angiography (QCA) at 6 months post-procedure.

**Time Frame:** 6 months post-procedure

#### Secondary Outcomes

**Measure:** In-lesion late loss as measured by QCA at 6 months post-procedure.

**Time Frame:** 6 months post-procedure

**Measure:** In-stent and in-lesion minimum lumen diameter (MLD) and percent diameter stenosis (%DS) by QCA post-procedure and at 6 months.

**Time Frame:** Post-procedure and at 6 months

**Measure:** Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.

**Measure:** Target Lesion Revascularization (TLR) at six and 12 months.

**Time Frame:** 6 and 12 months

**Measure:** Target Vessel Revascularization (TVR) at six and 12 months.

**Time Frame:** 6 and 12 months

**Measure:** Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months and 12 months post-procedure.

**Time Frame:** 30 days, 6 months and 12 months post-procedure

**Measure:** Stent Lumen and Stent Obstruction Volume by Intravascular Ultrasound (IVUS) at post procedure and six months follow-up.

**Time Frame:** post procedure and six months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. The patient must be minimum 18 years of age;
2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;

3 Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;

4. The target lesion is \>/=2.0 mm and \</=2.5mm in diameter (visual estimate);

5. The target lesion can be covered with a single 18mm stent;

6. Target lesion stenosis is \>50% and \<100% (TIMI I) (visual estimate);

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK\>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
2. Target lesion is due to in-stent restenosis;
3. Ejection fraction 30%;
4. Totally occluded vessel (TIMI 0 level);
5. Impaired renal function (creatinine \> 3.0 mg/dL);

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sao Paolo

**Country:** Brazil

**Facility:** Instituto Dante Pazzanese de Cardiologia

#### Overall Officials

**Official 1:**

**Affiliation:** Instituto Dante Pazzanese de Cardiologia

**Name:** J. E. Sousa, MD

**Role:** PRINCIPAL_INVESTIGATOR

## 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: 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

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- 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

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery 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

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000925

- Term: Anticoagulants

- ID: D000005343

- Term: Fibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

### Intervention Browse Module - Browse Branches

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M9579

- Name: Heparin

- Relevance: HIGH

- As Found: Obesity

- ID: M21960

- Name: Sirolimus

- Relevance: HIGH

- As Found: Included

- ID: M6097

- Name: Chromium

- Relevance: LOW

- As Found: Unknown

- ID: M46053

- Name: Calcium heparin

- Relevance: LOW

- As Found: Unknown

- ID: M6265

- Name: Cobalt

- Relevance: LOW

- As Found: Unknown

- 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

- ID: M4244

- Name: Anticoagulants

- Relevance: LOW

- As Found: Unknown

- ID: M8473

- Name: Fibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000020123

- Term: Sirolimus

- ID: D000006493

- Term: Heparin

### Misc Info Module

- Version Holder: 2024-05-24
