The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.

NCT ID: NCT00232791

Last Updated: 2008-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-03-31

Brief Summary

The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.

Detailed Description

This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions <23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Group Type: EXPERIMENTAL

Cypher Select

Intervention Type: DEVICE

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

2

CYPHER™ Sirolimus-eluting Coronary Stent

Group Type: ACTIVE_COMPARATOR

Cypher

Intervention Type: DEVICE

CYPHER™ Sirolimus-eluting Coronary Stent

Interventions

Cypher Select

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Intervention Type: DEVICE

Cypher

CYPHER™ Sirolimus-eluting Coronary Stent

Intervention Type: DEVICE

Other Intervention Names

PTCA; PTCA

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion;

3. Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);

4. Target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent;

5. Target lesion stenosis is > 50% and < 100% (visual estimate).

Exclusion Criteria

1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;

2. Unprotected left main coronary disease with more than 50% stenosis;

3. Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;

4. Have an ostial target lesion;

5. Angiographic evidence of thrombus within target lesion;

6. Calcified lesions which cannot be successfully predilated;

7. Ejection fraction less than 30%;

8. Totally occluded vessel (TIMI 0 level);

9. Direct Stenting;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Cordis

Principal Investigators

R. H. Stables, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiothoracic Centre Liverpool

Locations

Cardiothoracic Center Liverpool

Liverpool, , United Kingdom

Countries

United Kingdom

Other Identifiers

EC03-04

Identifier Type: -

Identifier Source: org_study_id