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

Cordis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Coronary Artery Disease

Treatments: Device: Cypher Select; Device: Cypher

Study type: Interventional

Funder types: Industry

Identifiers

NCT00232791

EC03-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

1

Experimental group

Description:

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Treatment:

Device: Cypher Select

2

Active Comparator group

Description:

CYPHER™ Sirolimus-eluting Coronary Stent

Treatment:

Device: Cypher