Status:
COMPLETED
A Study of the Cypher SES to Treat Restenotic Native 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 safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic n...
Detailed Description
This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography...
Eligibility Criteria
Inclusion
- The patient has an in-stent restenosis of ≥ 60% and \< 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery.
- The study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion.
Exclusion
- Unprotected left main coronary disease with ≥ 50% stenosis;
- Patient previously treated with brachytherapy in any coronary vessel.
- Target lesion involves bifurcation including a side branch \>2.5mm in diameter.
- The patient sustained a recent (\<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00232856
Start Date
December 1 2002
End Date
August 1 2006
Last Update
April 30 2008
Active Locations (2)
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1
K.U. Leuven
Leuven, Belgium, 3000
2
Herz-zentrum Bad Krozingen
Bad Krozingen, Germany, 78189