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Tracking Information | |||||||||||||
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First Received Date † | January 22, 2009 | ||||||||||||
Last Updated Date | January 22, 2009 | ||||||||||||
Start Date † | November 2008 | ||||||||||||
Current Primary Outcome Measures † |
Rate of binary restenosis as determined by duplex ultrasound. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | No Changes Posted | ||||||||||||
Current Secondary Outcome Measures † |
Resting ankle-brachial index [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ] | ||||||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease | ||||||||||||
Official Title † | PolarCath® Cryoplasty Versus Conventional Balloon Post-Dilation of Nitinol Stents for Peripheral Vascular Interventions (COBRA) | ||||||||||||
Brief Summary | Despite recent advances in stent technology and its widespread application in the treatment of peripheral vascular disease (PVD), incidences of partial or complete blockage of stent lumen (in-stent restenosis) due to in growth of cells (neo-intimal proliferation) is unacceptably high. In diabetics with long superficial femoral artery (SFA) lesions, in-stent restenosis rates are higher than in non-diabetics. Consequently interventional techniques that curtail in-stent restenosis have to be explored. Cryoplasty is a stent expansion method in which a balloon is expanded using pressurized nitrous oxide gas. As the nitrous oxide expands in the balloon it cools the surroundings to about -10 degrees C. This induces programed death (apoptosis) of the smooth muscle cells in arterial wall. The investigators hypothesize that Cryoplasty, by inducing an apoptotic smooth muscle cell response, when applied to post-dilation of nitinol self-expanding stents in the Superficial Femoral Artery (SFA) of diabetics, would lead to decreased in-stent restenosis due to decreased neointimal proliferation. |
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Detailed Description | The pre-recruitment process would identify diabetics who have life-style limiting claudication in their legs. Based on the physicians decision such patients may have to undergo a peripheral vascular intervention of the SFA, with placement of self-expanding nitinol stents. If such a decision is made, the patient will be randomized to either cryoplasty balloon post-dilation of the stent or to conventional angioplasty balloon post-dilation after obtaining informed consent. At one year, in segment (stent + 10 mm beyond its proximal and distal edges) peak systolic velocity by duplex ultrasound will be measured in all subjects to assess the rate of binary resteosis defined as a > or = 2.5 times increase in peak systolic velocity (primary endpoint). A 6 month resting ankle brachial index, and binary restenosis may be assessed as a secondary endpoint of the study. |
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Study Phase | |||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study | ||||||||||||
Condition † | Peripheral Vascular Disease | ||||||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Recruiting | ||||||||||||
Estimated Enrollment † | 132 | ||||||||||||
Estimated Completion Date | December 2010 | ||||||||||||
Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 21 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† |
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Location Countries † | United States | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00827853 | ||||||||||||
Responsible Party | Dr. Subhash Banerjee, Acting chief of cardiology, Dallas Veterans Hospital | ||||||||||||
Secondary IDs †† | |||||||||||||
Study Sponsor † | Boston Scientific Corporation | ||||||||||||
Collaborators †† | Texas Health Resources | ||||||||||||
Investigators † |
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Information Provided By | North Texas Veterans' Healthcare System | ||||||||||||
Verification Date | January 2009 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |