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

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Subhash Banerjee, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00827853
First received: January 22, 2009
Last updated: November 1, 2013
Last verified: November 2013

January 22, 2009
November 1, 2013
November 2008
August 2011   (final data collection date for primary outcome measure)
Rate of binary restenosis as determined by duplex ultrasound. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00827853 on ClinicalTrials.gov Archive Site
Resting ankle-brachial index [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
PERIPHERAL VASCULAR DISEASE
  • 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
  • Experimental: 1
    Conventional angioplasty balloon post-dilation of nitinol self expanding stents
    Intervention: Procedure: Conventional angioplasty balloon
  • Experimental: 2
    Cryoplasty balloon post-dilation
    Intervention: Procedure: cryoplasty balloon

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00827853
BOSTON SCI R&E 9-21-07#2
Yes
Subhash Banerjee, North Texas Veterans Healthcare System
North Texas Veterans Healthcare System
Boston Scientific Corporation
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
North Texas Veterans Healthcare System
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP