Status:
COMPLETED
A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.
Detailed Description
This is a prospective, randomized study that will be conducted at up to 5 centers in Europe and the US. All patients who meet the eligibility criteria will be treated with the sirolimus-coated Bx VELO...
Eligibility Criteria
Inclusion
- Has a 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) OR has documented silent ischemia;
- Involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
- Has a true bifurcation lesion defined as stenosis \> 50% in both the main branch and the ostium of the side branch;
- Has a main branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line QCA proximal to the bifurcation;
- Has a side branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line QCA.
Exclusion
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented elevation of CK levels \> 2 times normal or CK-MB levels \> 3 times normal within the preceding 24 hours and/or the CK and CK-MB enzymes remain above normal at the time of treatment;
- Has unstable angina classified as Braunwald A I-III, or III B or C, or is having a peri infarction;
- Has a bifurcation lesion in a non protected left main;
- Has an ejection fraction \<=35%;
- There is presence of thrombus in the bifurcation lesion;
- Has a totally occluded vessel.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00234455
Start Date
June 1 2001
End Date
April 1 2007
Last Update
April 30 2008
Active Locations (1)
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1
Centre Cuore Columbus
Milan, Italy, I-20145