Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease - Full Text View

Sponsors and Collaborators:	Boston Scientific Corporation Texas Health Resources
Information provided by:	North Texas Veterans' Healthcare System
ClinicalTrials.gov Identifier:	NCT00827853

Purpose

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	Intervention
Peripheral Vascular Disease	Procedure: Conventional angioplasty balloon Procedure: cryoplasty balloon

MedlinePlus related topics: Angioplasty Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	PolarCath® Cryoplasty Versus Conventional Balloon Post-Dilation of Nitinol Stents for Peripheral Vascular Interventions (COBRA)

Further study details as provided by North Texas Veterans' Healthcare System:

Primary Outcome Measures:

Rate of binary restenosis as determined by duplex ultrasound. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Resting ankle-brachial index [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Conventional angioplasty balloon post-dilation	Procedure: Conventional angioplasty balloon Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using conventional angioplasty balloon
2: Experimental Cryoplasty balloon post-dilation	Procedure: cryoplasty balloon Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using cryoplasty balloon

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 resteosis 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827853

Contacts

Contact: Subhash Banerjee, MD	(214)857-1608	subhash.banerjee@utsouthwestern.edu
Contact: Cyril Varghese, MS		zcman84@yahoo.com

Locations

United States, Texas
Dallas Veterans Hospital	Recruiting
Dallas, Texas, United States, 75216
Contact: Subhash Banerjee, MD subhash.banerjee@utsouthwestern.edu
Contact: Cyril Varghese zcman84@yahoo.com
Principal Investigator: Subhash Banerjee, MD
Dallas Presbyterian Hospital	Recruiting
Dallas, Texas, United States, 75231
Contact: Tony Das, MD 214-360-0869
Contact: Victoria Skobel, RN,MS Vskobel@CIVADALLAS.COM
Principal Investigator: Tony Das, MD

Sponsors and Collaborators

Boston Scientific Corporation

Texas Health Resources

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

More Information

Publications:

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

Grassl ED, Bischof JC. In vitro model systems for evaluation of smooth muscle cell response to cryoplasty. Cryobiology. 2005 Apr;50(2):162-73.

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.

Responsible Party:	Dallas Veterans Hospital ( Dr. Subhash Banerjee, Acting chief of cardiology )
Study ID Numbers:	BOSTON SCI R&E 9-21-07#2
Study First Received:	January 22, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00827853 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Keywords provided by North Texas Veterans' Healthcare System:

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

Study placed in the following topic categories:

Peripheral Vascular Diseases
Dilatation, Pathologic
Diabetes Mellitus
Vascular Diseases

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009