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

Primary Purpose

PERIPHERAL VASCULAR DISEASE

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Conventional angioplasty balloon

cryoplasty balloon

About this trial

This is an interventional treatment trial for PERIPHERAL VASCULAR DISEASE focused on measuring Diabetes, Peripheral Vascular Disease (PVD), Superficial Femoral Artery (SFA), Cryoplasty, Restenosis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Midwest Cardiovascular Research Foundation
VA Medical Center
Dallas Veterans Hospital
Dallas Presbyterian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Conventional angioplasty balloon post-dilation of nitinol self expanding stents

Cryoplasty balloon post-dilation

Outcomes

Primary Outcome Measures

Rate of binary restenosis as determined by duplex ultrasound.

Secondary Outcome Measures

Resting ankle-brachial index

Full Information

NCT ID

NCT00827853

First Posted

January 22, 2009

Last Updated

November 1, 2013

Sponsor

North Texas Veterans Healthcare System

Collaborators

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00827853

Brief Title

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

Acronym

COBRA

Official Title

PolarCath® Cryoplasty Versus Conventional Balloon Post-dilation of Nitinol Stents for Peripheral Vascular Interventions (COBRA)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

North Texas Veterans Healthcare System

Collaborators

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PERIPHERAL VASCULAR DISEASE

Keywords

Diabetes, Peripheral Vascular Disease (PVD), Superficial Femoral Artery (SFA), Cryoplasty, Restenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Conventional angioplasty balloon post-dilation of nitinol self expanding stents

Arm Title

Arm Type

Experimental

Arm Description

Cryoplasty balloon post-dilation

Intervention Type

Procedure

Intervention Name(s)

Conventional angioplasty balloon

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

cryoplasty balloon

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of binary restenosis as determined by duplex ultrasound.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Resting ankle-brachial index

Time Frame

6 months and 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Subhash Banerjee, MD

Organizational Affiliation

VA North Texas Healthcare Systen, Dallas, TX

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Emmanouil S Brilakis, MD, PhD

Organizational Affiliation

VA North Texas Healtcare System, Dallas, TX

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tony S Das, MD

Organizational Affiliation

Texas Health Resources

Official's Role

Study Director

Facility Information:

Facility Name

Midwest Cardiovascular Research Foundation

City

Davenport

State/Province

Iowa

ZIP/Postal Code

52803

Country

United States

Facility Name

VA Medical Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Dallas Veterans Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Dallas Presbyterian Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11094034

Citation

Minar E, Pokrajac B, Maca T, Ahmadi R, Fellner C, Mittlbock M, Seitz W, Wolfram R, Potter R. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study. Circulation. 2000 Nov 28;102(22):2694-9. doi: 10.1161/01.cir.102.22.2694.

Results Reference

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PubMed Identifier

16672699

Citation

Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.

Results Reference

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PubMed Identifier

11200349

Citation

Cejna M, Thurnher S, Illiasch H, Horvath W, Waldenberger P, Hornik K, Lammer J. PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study. J Vasc Interv Radiol. 2001 Jan;12(1):23-31. doi: 10.1016/s1051-0443(07)61397-9.

Results Reference

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PubMed Identifier

12618680

Citation

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Results Reference

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PubMed Identifier

15683273

Citation

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Results Reference

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PubMed Identifier

1294068

Citation

Johnston KW. Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. Radiology. 1992 Jun;183(3):767-71. doi: 10.1148/radiology.183.3.1294068.

Results Reference

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PubMed Identifier

10811511

Citation

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PubMed Identifier

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Citation

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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Results Reference

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

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