Renal Artery Stenosis Clinical Trial
— GREATOfficial title:
Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.
Verified date | August 2008 |
Source | Cordis Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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 stenosis, measured at 6 months follow up via angiography.
Status | Completed |
Enrollment | 105 |
Est. completion date | July 2005 |
Est. primary completion date | November 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. The reference vessel renal artery must be >= 4mm and <= 8 mm by visual estimate. 3. The patient must have a baseline serum creatinine of <= 5.0 mg/dl. Exclusion Criteria: 1. Total occlusion of the renal artery. 2. Lesions which would require more than 2 stents. 3. Lesions which are in arteries to transplanted or bypassed kidneys. 4. Abdominal aortic aneurysm > 4.0 cm in diameter. 5. Patients with ASA classification >=4. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hopital Européen Georges Pompidou | Paris | |
Germany | Universitätskliniken Köln | Köln | |
Netherlands | Erasmus MC Rotterdam | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Cordis Corporation |
France, Germany, Netherlands,
Zähringer M, Sapoval M, Pattynama PM, Rabbia C, Vignali C, Maleux G, Boyer L, Szczerbo-Trojanowska M, Jaschke W, Hafsahl G, Downes M, Bérégi JP, Veeger NJ, Stoll HP, Talen A. Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | assessment of the angiographical in-stent minimal lumen diameter | 6-months follow up | Yes | |
Secondary | clinical primary patency | discharge, 1, 6 and 12 months post-procedure | Yes | |
Secondary | procedural success | post-procedure | Yes | |
Secondary | worsening renal function | 30 days, 6 months, 12 months | Yes | |
Secondary | change in blood pressure measurement | 30 days, 6 months, 12 months | Yes | |
Secondary | significant embolic events causing end-organ damage | 30 days, 6 months, and 12 months | Yes |
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