Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease
| Status: | Archived |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2008 |
| End Date: | December 2010 |
PolarCath® Cryoplasty Versus Conventional Balloon Post-dilation of Nitinol Stents for Peripheral Vascular Interventions (COBRA)
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.
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 restenosis 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.
We found this trial at
4
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials