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Sponsored by: |
Abbott Vascular |
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Information provided by: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT00180505 |
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
Condition | Intervention | Phase |
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Peripheral Vascular Diseases |
Device: ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Non-Randomized, Prospective, Multi-Center Evaluation of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System for Occluded or Stenotic Superficial Femoral or Proximal Popliteal Arteries |
Estimated Enrollment: | 120 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
The purpose of the ASSESS Registry is to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
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Device: ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
A prospective, non-randomized, multi-center study to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Follow up at 30, 180, 270, 365 days and 2 years.
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The treatment of stenosis in superficial femoral arteries and/or proximal popliteal arteries with stenting is associated with high restenosis rates, especially with the first generation stents (stainless steel). Currently, self-expandable nitinol stents are commercialized which lead to higher primary patency rates as compared to the first generation stents, even in longer lesions. However, until now most data available are retrospective and uni-center. The ASSESS study is a prospective multi-center study investigating the performance (restenosis rate, patency rates) of the ABSOLUTE™. 035 peripheral self-expandable stent in longer lesions (lesion length from 4.00 mm to 200.00 mm).
Moreover, literature shows stent fracture in nitinol stents, with a possible clinical relationship. For this reason, the ASSESS study will analyze the stent fractures of the ABSOLUTE™ stent, and a possible relationship between stent fracture and restenosis.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters:
Exclusion Criteria:
Austria | |
Allgemeines Krankenhaus der Stadt Wien (AKH Wien) | |
Wien, Austria, 1090 | |
Landeskrankenhaus Klagenfurt | |
Klagenfurt, Austria, 9026 | |
Belgium | |
CHR de Namur | |
Namur, Belgium, 5000 | |
France | |
Polyclinique Louis Pasteur | |
Essey les Nancy, France, 54270 | |
Hôpital Pontchaillou- CHU | |
Rennes Cedex, France, 35033 | |
Germany | |
Herzzentrum Leipzig | |
Leipzig, Germany, 04289 | |
Herzzentrum Bad Krozingen | |
Bad Krozingen, Germany, 79189 | |
Universitäres Herz & Gefässzentrum Hamburg | |
Hamburg, Germany, 22527 | |
Greece | |
Papageorgiou Hospital | |
Thessaloniki, Greece, 57001 | |
Italy | |
Casa di Cura Montevergine | |
Mercogliano, Italy, 83013 | |
Nuovo Ospedale Civile Sant' Agostino | |
Baggiovara (Modena), Italy, 41100 | |
Policlinico San Matteo | |
Pavia, Italy, 27100 | |
Spain | |
Hospital de Donostia | |
Donostia-San Sebastian, Spain, 20014 |
Principal Investigator: | Thomas Zeller, M.D. | Herzzentrum Bad Krozingen, Germany |
Responsible Party: | Abbott Cardiovascular Systems, Inc. A Subsidiary of Abbott Vascular, Inc. ( Matt Kiely ) |
Study ID Numbers: | 04-100 |
Study First Received: | September 13, 2005 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00180505 |
Health Authority: | France: Institutional Ethical Committee |
Peripheral Artery Disease Restenosis Rate Patency Rates Self-Expandable Nitinol Stents Stent Fractures |
Peripheral Vascular Diseases Fractures, Bone Vascular Diseases |
Cardiovascular Diseases |