At a glance
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PolarCath® Cryoplasty Versus Conventional Balloon Post-dilation of Nitinol Stents for Peripheral Vascular Interventions (COBRA)
In Brief
A clinical study evaluating Conventional angioplasty balloon and cryoplasty balloon for PERIPHERAL VASCULAR DISEASE. Completed, enrolled 90 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using conventional angioplasty balloon
Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using cryoplasty balloon