COBRA: Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Rate of binary restenosis as determined by duplex ultrasound. [1 year]
Secondary Outcome Measures
- Resting ankle-brachial index [6 months and 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diabetics, insulin or non-insulin dependent above 21 years of age
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Able to provide an informed consent
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Life expectancy > 1 year
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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
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Placement of > 60 mm in length self-expanding Nitinol stent in the SFA, with at least 1 vessel infra-popliteal runoff
Exclusion Criteria:
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Serum creatinine of >= 2.0 mg/dl
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Presence of iodinated contrast allergy
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Presence of allergy to Aspirin and Plavix
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Pregnancy
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Relative or absolute contraindication for anticoagulation
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History of allergy to Angiomax and unfractionated heparin or heparin induced thrombocytopenia (HIT)
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White blood count < 3000; platelet count < 100000, and baseline hemoglobin < 10 g/dl
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Absence of brisk at least 1 vessel infra-popliteal runoff to the foot
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Left ventricular ejection fraction < 25%
-
Relative or absolute contraindication for anticoagulation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Midwest Cardiovascular Research Foundation | Davenport | Iowa | United States | 52803 |
| 2 | VA Medical Center | Oklahoma City | Oklahoma | United States | 73104 |
| 3 | Dallas Veterans Hospital | Dallas | Texas | United States | 75216 |
| 4 | Dallas Presbyterian Hospital | Dallas | Texas | United States | 75231 |
Sponsors and Collaborators
- North Texas Veterans Healthcare System
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Becquemin JP, Favre JP, Marzelle J, Nemoz C, Corsin C, Leizorovicz A. Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study. J Vasc Surg. 2003 Mar;37(3):487-94.
- 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.
- Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, Wiesinger B, Hak JB, Tielemans H, Ziemer G, Cristea E, Lansky A, Bérégi JP. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation. 2002 Sep 17;106(12):1505-9.
- Grassl ED, Bischof JC. In vitro model systems for evaluation of smooth muscle cell response to cryoplasty. Cryobiology. 2005 Apr;50(2):162-73.
- Johnston KW. Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. Radiology. 1992 Jun;183(3):767-71.
- Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D, Zetterlund P, Moen E, Joye JD. Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry. J Vasc Interv Radiol. 2005 Aug;16(8):1067-73.
- Minar E, Pokrajac B, Maca T, Ahmadi R, Fellner C, Mittlböck M, Seitz W, Wolfram R, Pötter R. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study. Circulation. 2000 Nov 28;102(22):2694-9.
- Sabeti S, Mlekusch W, Amighi J, Minar E, Schillinger M. Primary patency of long-segment self-expanding nitinol stents in the femoropopliteal arteries. J Endovasc Ther. 2005 Feb;12(1):6-12.
- Sabeti S, Schillinger M, Amighi J, Sherif C, Mlekusch W, Ahmadi R, Minar E. Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: propensity score-adjusted analysis. Radiology. 2004 Aug;232(2):516-21.
- Schillinger M, Exner M, Mlekusch W, Haumer M, Sabeti S, Ahmadi R, Schwarzinger I, Wagner O, Minar E. Restenosis after femoropopliteal PTA and elective stent implantation: predictive value of monocyte counts. J Endovasc Ther. 2003 Jun;10(3):557-65.
- 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.
- Venkatasubramanian RT, Grassl ED, Barocas VH, Lafontaine D, Bischof JC. Effects of freezing and cryopreservation on the mechanical properties of arteries. Ann Biomed Eng. 2006 May;34(5):823-32. Epub 2006 Apr 18.
- Yiu WK, Cheng SW, Sumpio BE. Vascular smooth muscle cell apoptosis induced by "supercooling" and rewarming. J Vasc Interv Radiol. 2006 Dec;17(12):1971-7.
- Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thörne J, Norgren L. Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study. Int Angiol. 1999 Dec;18(4):251-5.
- BOSTON SCI R&E 9-21-07#2