Status:
COMPLETED
A Comparison of Coated and Uncoated Stents in Renal Artery Treatment.
Lead Sponsor:
Cordis US Corp.
Conditions:
Renal Artery Stenosis
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosi...
Detailed Description
Multi-center, prospective, controlled, non-randomized investigational feasibility study. One hundred (100) patients with de novo or restenotic renal artery lesions consisting of \>= 50% stenosis and r...
Eligibility Criteria
Inclusion
- Clinical indication for renal artery revascularization of atherosclerotic renal artery stenosis \>=50% as measured by operator or estimated original vessel diameter, based on healthy vessel segment and contralateral side.
- The reference vessel renal artery must be \>= 4mm and \<= 8 mm by visual estimate.
- The patient must have a baseline serum creatinine of \<= 5.0 mg/dl.
Exclusion
- Total occlusion of the renal artery.
- Lesions which would require more than 2 stents.
- Lesions which are in arteries to transplanted or bypassed kidneys.
- Abdominal aortic aneurysm \> 4.0 cm in diameter.
- Patients with ASA classification \>=4.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00235157
Start Date
November 1 2001
End Date
July 1 2005
Last Update
August 6 2008
Active Locations (3)
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1
Hopital Européen Georges Pompidou
Paris, France, 75 015
2
Universitätskliniken Köln
Cologne, Germany, 50931
3
Erasmus MC Rotterdam
Rotterdam, Netherlands, 3000 CA