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

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Cypher Select; Device: Cypher

• Registration Number: NCT00232791
• Lead Sponsor: Cordis Corporation

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-08
• Study Completion: 2005-03
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-05
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-05
• Last Update Posted: 2008-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cypher Select	CYPHER SELECT™ Sirolimus-eluting Coronary Stent
2	Cypher	CYPHER™ Sirolimus-eluting Coronary Stent

Primary Outcome Measures

Name	Time	Method
Angiographic in-stent late loss	6 months

Secondary Outcome Measures

Name	Time	Method
In-stent mean percent diameter stenosis	anytime post-procedure
In-target vessel segment MLD	6 months
In-stent MLD	6 months
Target Lesion Revascularization (TLR)	6 months
Target Vessel Revascularization (TVR)	6 months
Major Adverse Cardiac Events (MACE)	30 days, 6 and 12 months
In-stent volume of restenosis determined by IVUS	6 months

Trial Locations

Locations (1)

Cardiothoracic Center Liverpool; 🇬🇧 Liverpool, United Kingdom