Status:
COMPLETED
The CYPHER™ Stent Study in Patients With Small de Novo Coronary Artery Lesions.
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main objective of this study is to assess the effectiveness of the CYPHER™ (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary artery lesions in small vessel...
Detailed Description
This is an international, multicenter (up to 10 sites), nonrandomized, historically controlled study in patients with De Novo coronary artery lesions in small vessels treated with the CYPHER™ (sirolim...
Eligibility Criteria
Inclusion
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS 1, 2, 3, 4) OR unstable angina pectoris (Braunwald Classification B\&C 1-2) OR patients with documented silent ischemia;
- Single treatment of de novo lesion in a small vessel (2.25 - 2.75 mm) in a major coronary artery in patients with single or multivessel disease. Patients with multiple lesions can be included if the other lesions are successfully treated prior to the treatment of the intended lesion in the small vessel.
- Target vessel diameter \>=2.25 and \<=2.75mm (by visual estimation);
- Target lesion length \>=15 and \<=30 mm.
Exclusion
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours or the CK and CK-MB remains above normal at the time of the treatment;
- Has unstable angina classified as Braunwald A (1, 2, 3) or B \& C 3;
- Unprotected left main coronary disease with \>=50% stenosis;
- Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
- Have an ostial target lesion;
- Lesion \< 2.25 or \> 2.75 mm in diameter;
- Totally occluded vessel (TIMI 0 level);
- Documented left ventricular ejection fraction £30%;
- Intention to treat the target lesion by direct stenting procedure.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00235066
Start Date
November 1 2002
End Date
April 1 2006
Last Update
September 16 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital, Swiss Cardiovascular CenterBern
Bern, Switzerland, 3010