Coronary Artery Disease
Conditions
Brief summary
The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.
Detailed description
This is a prospective, randomized study conducted at 90 centers in Europe, Latin-America and Asia. A total of 1335 patients will be entered into the study and will be randomized on a 1:1 basis to either the sirolimus-eluting or the paclitaxel-eluting stent system. All patients will have repeat angiography at eight months and will be followed for 24 months post-procedure.
Interventions
DEVICETaxus Paclitaxel-Eluting Stent
Sponsors
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries; 3. Ostial lesions; 4. Bifurcations; 5. Target vessel diameter of both lesions must be \>=2.25mm and \<=3.0mm in diameter (visual estimate); 6. One target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either; 7. Target lesion stenosis for both lesions is \>50% and \<100% (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 72 hours and the CK and CK-MB enzymes remain above normal at the time of treatment; 2. Has unstable angina classified as Braunwald A I-II-III; 3. Any of the lesions is an unprotected left main coronary disease with \>=50% stenosis; 4. Angiographic evidence of thrombus within target lesion; 5. Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions); 6. Documented left ventricular ejection fraction \<=25%; 8\. Totally occluded vessel (TIMI 0 level) (applies to both lesions); 9\. Prior stent within 10mm of target lesion (applies to both lesions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA. | — |
Countries
France
Outcome results
None listed