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Sponsored by: |
Flanders Medical Research Program |
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Information provided by: | Flanders Medical Research Program |
ClinicalTrials.gov Identifier: | NCT00510393 |
The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. It will be investigated whether there is a difference in 12 month angiographic patency of the stented area using the 2 different stent systems.
Condition | Intervention | Phase |
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Peripheral Vascular Disease Critical Limb Ischemia |
Device: XIENCE V everolimus eluting coronary stent system Device: MULTILINK VISION coronary stent system |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The DESTINY Trial: a Prospective Randomized Multicenter Trial Comparing the Implant of a Drug Eluting Stent (XIENCE V, Abbott Vascular) vs. a Bare Metal Stent (MULTILINK VISION, Abbott Vascular) in the Critically Ischemic Lower Leg |
Estimated Enrollment: | 140 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
drug eluting stent
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Device: XIENCE V everolimus eluting coronary stent system
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2: Placebo Comparator
Bare Metal Stent
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Device: MULTILINK VISION coronary stent system
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Koen De Meester | +3252252822 | koen.demeester@fmrp.be |
Belgium | |
AZ Sint-Blasius | Recruiting |
Dendermonde, Belgium, 9200 | |
Contact: Marc Bosiers, MD +32 52252822 marc.bosiers@telenet.be | |
Principal Investigator: Marc Bosiers, MD | |
Sub-Investigator: Koen Deloose, MD | |
Imelda Hospital | Recruiting |
Bonheiden, Belgium, 2820 | |
Contact: Patrick Peeters, MD +32 15506197 patrick.peeters@imelda.be | |
Principal Investigator: Patrick Peeters, MD | |
France | |
Polyclinique Les Fleurs | Not yet recruiting |
Ollioules, France, 83192 | |
Contact: Philippe Commeau, MD p.commeau@wanadoo.fr | |
Principal Investigator: Philippe Commeau, MD | |
Germany | |
Herzzentrum | Not yet recruiting |
Leipzig, Germany, 04289 | |
Contact: Dierk Schneinert, MD +49 3418651740 dierk.scheinert@gmx.de | |
Principal Investigator: Dierk Scheinert, MD | |
Herz-zentrum Bad Krozingen | Not yet recruiting |
Bad Krozingen, Germany, 79189 | |
Contact: Thomas Zeller, MD +49 7633402807 thomas.zeller@herzzentrum.de | |
Principal Investigator: Thomas Zeller, MD |
Principal Investigator: | Marc Bosiers, MD | AZ Sint-Blasius, Dendermonde, Belgium |
Principal Investigator: | Dierk Scheinert, MD | Herzzentrum, Leipzig, Germany |
Responsible Party: | Flanders Medical Research Program (FMRP) ( Flanders Medical Research Program (FMRP) ) |
Study ID Numbers: | FMRP-002 |
Study First Received: | August 1, 2007 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00510393 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices; France: Institutional Ethical Committee; France: Direction Générale de la Santé |
Critical Limb Ischemia CLI Drug Eluting Stent |
DES Bare Metal Stent BMS |
Everolimus Peripheral Vascular Diseases Vascular Diseases Ischemia |
Pathologic Processes Cardiovascular Diseases |