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

November 1, 2013 updated by: Subhash Banerjee, North Texas Veterans Healthcare System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest Cardiovascular Research Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • VA Medical Center
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas Veterans Hospital
      • Dallas, Texas, United States, 75231
        • Dallas Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetics, insulin or non-insulin dependent above 21 years of age
  • Able to provide an informed consent
  • Life expectancy > 1 year
  • Presenting with with moderate claudication (Rutherford stage 2), severe intermittent claudication (Rutherford stage 3), chronic critical limb ischemia with pain while the patient was at rest(Rutherford stage 4), or chronic critical limb ischemia with ischemic ulcers/gangrene(Rutherford stage 5/6)
  • Placement of > 5 mm in diameter self-expanding Nitinol stent in the SFA, with at least 1 vessel infra-popliteal runoff
  • Placement of > 60 mm in length self-expanding Nitinol stent in the SFA, with at least 1 vessel infra-popliteal runoff

Exclusion Criteria:

  • Serum creatinine of >= 2.0 mg/dl
  • Presence of iodinated contrast allergy
  • Presence of allergy to Aspirin and Plavix
  • Pregnancy
  • Relative or absolute contraindication for anticoagulation
  • History of allergy to Angiomax and unfractionated heparin or heparin induced thrombocytopenia (HIT)
  • White blood count < 3000; platelet count < 100000, and baseline hemoglobin < 10 g/dl
  • Absence of brisk at least 1 vessel infra-popliteal runoff to the foot
  • Left ventricular ejection fraction < 25%
  • Relative or absolute contraindication for anticoagulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Conventional angioplasty balloon post-dilation of nitinol self expanding stents
Procedure: Conventional angioplasty balloon
Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using conventional angioplasty balloon
EXPERIMENTAL: 2
Cryoplasty balloon post-dilation
Procedure: cryoplasty balloon
Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using cryoplasty balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of binary restenosis as determined by duplex ultrasound.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Resting ankle-brachial index
Time Frame: 6 months and 1 year
6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Subhash Banerjee, MD, VA North Texas Healthcare Systen, Dallas, TX
  • Study Director: Emmanouil S Brilakis, MD, PhD, VA North Texas Healtcare System, Dallas, TX
  • Study Director: Tony S Das, MD, Texas Health Resources

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (ESTIMATE)

January 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOSTON SCI R&E 9-21-07#2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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