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Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease

NCT00827853 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-11-04

No results posted yet for this study

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.

Conditions

  • PERIPHERAL VASCULAR DISEASE

Interventions

PROCEDURE

Conventional angioplasty balloon

Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using conventional angioplasty balloon

PROCEDURE

cryoplasty balloon

Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using cryoplasty balloon

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • North Texas Veterans Healthcare System

    lead FED

Principal Investigators

  • Subhash Banerjee, MD · VA North Texas Healthcare Systen, Dallas, TX

  • Emmanouil S Brilakis, MD, PhD · VA North Texas Healtcare System, Dallas, TX

  • Tony S Das, MD · Texas Health Resources

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-08-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827853 on ClinicalTrials.gov