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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00235157 |
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.
Condition | Intervention | Phase |
---|---|---|
Renal Artery Stenosis |
Device: Sirolimus-eluting Palmaz Genesis peripheral stent |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment. |
Enrollment: | 105 |
Study Start Date: | November 2001 |
Study Completion Date: | July 2005 |
Primary Completion Date: | November 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Sirolimus-eluting Palmaz Genesis peripheral stent
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Device: Sirolimus-eluting Palmaz Genesis peripheral stent
treatment of renal artery stenosis with a renal stent
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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 reference vessel of >= 4.0 to <= 8.0 mm in diameter will be sequentially included, 50 without sirolimus coating, followed by 50 with sirolimus coating Palmaz GenesisTM. Patients will be followed for 24 months post-procedure, with all patients having clinical assessments at discharge, 1,6, 12 and 24 months. This study will be conducted at twelve investigational sites.
It is anticipated that the total length of time required to complete the study will be 46 months.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Hopital Européen Georges Pompidou | |
Paris, France, 75 015 | |
Germany | |
Universitätskliniken Köln | |
Köln, Germany, 50931 | |
Netherlands | |
Erasmus MC Rotterdam | |
Rotterdam, Netherlands, 3000 CA |
Principal Investigator: | Markus Zähringer, MD | Universitätskliniken Köln |
Principal Investigator: | Marc Sapoval, MD | Hopital Européen Georges Pompidou |
Principal Investigator: | Peter M Pattynama, MD | Erasmus MC Rotterdam |
Responsible Party: | Cordis ( Dr. Hans-Peter Stoll, Director Clinical Affairs ) |
Study ID Numbers: | EE01-01 |
Study First Received: | October 6, 2005 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00235157 |
Health Authority: | Germany: Ethics Commission |
Sirolimus Arterial Occlusive Diseases Renal artery stenosis Urologic Diseases Clotrimazole Miconazole |
Tioconazole Vascular Diseases Constriction, Pathologic Kidney Diseases Renal Artery Obstruction |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |