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Sponsors and Collaborators: |
Boston Scientific Corporation KIKA |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00352222 |
To obtain additional data on safety and efficacy of the Express stent implantation in the treatment of stenosed or occlusive atherosclerotic disease (de novo or restenotic lesions) in the iliac arteries (common or external).
Condition | Intervention | Phase |
---|---|---|
Arterial Occlusive Disease Intermittent Claudication Atherosclerotic Disease Thrombosis |
Device: stent implantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multicenter, Single Arm Study to Obtain Additional Data on the Safety and Efficacy of the Express Vascular LD Implantation in the Treatment of Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries |
Estimated Enrollment: | 150 |
Study Start Date: | January 2004 |
Study Completion Date: | February 2007 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
This study was conducted to provide additional data on the safety and efficacy of the Express™ Vascular LD stent, particularly with regard to the long-term patency in iliac arteries. The study would provide data on angiographic endpoints and clinical outcomes at 30 days, 6 months, and at 12 and 24 months post implantation in atherosclerotic lesions in iliac arteries. The data obtained in this study with the use of the Express™ Vascular LD stent was compared with historical data obtained from the use of the Palmaz balloon-expandable stent. The Palmaz balloon expandable stent has been chosen as the control device because it is currently the only FDA-approved balloon-expandable stent for use in the percutaneous treatment of atherosclerotic disease in iliac arteries. The Palmaz balloon-expandable stent is no longer commercialized in Europe. Therefore a randomized study with the Palmaz balloon-expandable stent was not feasible. In addition, there are no ongoing or published randomized trials describing performance of a newer version of the Palmaz stent in iliac atherosclerotic lesions. In order to adequately compare the efficacy data of the ExpressTM Vascular LD stent with the efficacy data of the Palmaz balloon-expandable stent, the same efficacy parameter as in the publication on the Palmaz balloon-expandable stent was measured in this study: % mean loss of the luminal diameter at 6 months post-procedure. The findings of the longer-term Follow-Up assessments at 12 and 24 months will be presented as the results from these assessments become available.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Sint Trudo Hospital | |
Sint Truiden, Belgium, 3800 | |
Limburgs Vaatcentrum Ziekenhuis Oost-Limburg | |
Genk, Belgium, 3600 | |
Canada, Quebec | |
CHUM- Notre Dame Hospital | |
Montreal, Quebec, Canada, H2L 4M1 | |
Czech Republic | |
Institute for Clinical and Experimental Medicine (IKEM) | |
Praha, Czech Republic, 14021 | |
General Teaching Hospital Prague | |
Praha, Czech Republic, 12808 | |
Netherlands, cm | |
Sint Antonius Hospital | |
Nieuwegein, cm, Netherlands, 3435 | |
Poland | |
University School of Medicine | |
Lublin, Poland, 20-954 | |
University Hospital of Krakow | |
Krakow, Poland, 31-066 | |
Samodzielny Publiczny Centraln Szpital | |
Warszawa, Poland, 02-097 | |
Center of Diagnostic Imaging and Vascular Disease Treatment | |
Szczecin, Poland, 71-232 |
Principal Investigator: | Luc Stockx, MD | Limburgs Vaatcentrum Ziekenhuis Oost-Limburg, Belgium |
Responsible Party: | Boston Scientific ( Anne Cornaille ) |
Study ID Numbers: | S2015, MTE-E-0301 |
Study First Received: | July 12, 2006 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00352222 History of Changes |
Health Authority: | Netherlands: Independent Ethics Committee; Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Japan: Pharmaceuticals and Medical Devices Agency |
iliac arteries implantation treatment of atherosclerotic disease stenosed occlusive |
Arterial Occlusive Diseases Signs and Symptoms Embolism and Thrombosis Embolism |
Vascular Diseases Intermittent Claudication Arteriosclerosis Thrombosis |
Arterial Occlusive Diseases Signs and Symptoms Embolism and Thrombosis Vascular Diseases |
Intermittent Claudication Cardiovascular Diseases Arteriosclerosis Thrombosis |