A Prospective, Randomized Intra-Individual Study With the Sirolimus Coated Cypher Select(TM) and the Paclitaxel(TM) Coated Express Balloon Expandable Stents for the Treatment of Patients With Two de Novo Native Coronary Artery Lesions.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- University Hospital Freiburg
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses (prospective, randomized, intra-individual comparison).
Detailed Description
This is a prospective, 2 arm, randomized, multicenter Phase III study (6 centers). A total of 110 patients with at least two de novo native coronary artery lesions (lesion A, lesion B) ≤ 30 mm in length and ≥ 2.25 mm to \< 3.0 mm in diameter by visual estimate will be enrolled. Patients will be randomized for implantation of the sirolimus eluting Cypher Select(TM) Balloon-Expandable Stent or to the TAXUS(TM) Paclitaxel-eluting stent for lesion A and B.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient must be \>=18 and \<=85 years of age
- •Female of childbearing potential must have a negative pregnancy test at the time of enrolment and utilize reliable birth control for the duration of their participation in the trial
- •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) and documented ischemia OR patients with documented silent ischemia
- •Two or more de novo lesions \< 30 mm in length (visual estimate)
- •Target vessel at lesion site is ≥ 2.25 mm and ≤ 3.0 mm in diameter (visual estimate)
- •Target lesion is located in a native coronary artery which can be covered by one stent (single lesion)
- •Acceptable candidate for coronary artery bypass surgery (CABG)
- •Target lesion stenosis is \> 50% and \< 100% (thrombolysis in myocardial infarction \[TIMI\] 1) (visual estimate)
- •Target lesions do not differ in length for more than 6 mm
- •Patient is willing to comply with the specified follow-up evaluation
Exclusion Criteria
- •Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal
- •Unprotected left main coronary disease with \>= 50% stenosis
- •Impaired runoff in the treatment vessel with diffuse distal disease
- •Ostial target lesion
- •Angiographic evidence of thrombus within target lesion
- •Calcified lesions which cannot be successfully predilated
- •Ejection fraction \<= 30%
- •Totally occluded vessel (TIMI 0 level)
- •Impaired renal function (creatinine \> 3.0 mg/dl)
- •Pretreatment with devices other than balloon angioplasty
Outcomes
Primary Outcomes
The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography
Time Frame: 8 months
Secondary Outcomes
- Target lesion and vessel revascularization (TLR, TVR)(12 months)
- Major adverse cardiac events (MACE) at 30 days, 8 and 12 months(30 days, 8 and 12 months)