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

NCT00827853 | Completed DMC

• 1 other identifier: BOSTON SCI R&E 9-21-07#2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

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.

Conditions

PERIPHERAL VASCULAR DISEASE

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of binary restenosis as determined by duplex ultrasound.

  1 year

Secondary Outcomes (1)

• Resting ankle-brachial index

  6 months and 1 year

Study Arms (2)

1

EXPERIMENTAL

Conventional angioplasty balloon post-dilation of nitinol self expanding stents

Procedure: Conventional angioplasty balloon

2

EXPERIMENTAL

Cryoplasty balloon post-dilation

Procedure: cryoplasty balloon

Interventions

Conventional angioplasty balloon PROCEDURE

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

1

cryoplasty balloon PROCEDURE

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

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead
• Boston Scientific Corporation: collaborator

Study Sites (4)

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Dallas Veterans Hospital

Dallas, Texas, 75216, United States

Location

Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Related Publications (15)

• 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.

  PMID: 11094034 BACKGROUND

• 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.

  PMID: 16672699 BACKGROUND

• 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.

  PMID: 11200349 BACKGROUND

• 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. doi: 10.1067/mva.2003.155.

  PMID: 12618680 BACKGROUND

• 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. doi: 10.1583/04-1359.1.

  PMID: 15683273 BACKGROUND

• 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.

  PMID: 1294068 BACKGROUND

• Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thorne 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.

  PMID: 10811511 BACKGROUND

• 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. doi: 10.1148/radiol.2322031345.

  PMID: 15286322 BACKGROUND

• Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, Wiesinger B, Hak JB, Tielemans H, Ziemer G, Cristea E, Lansky A, Beregi JP. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation. 2002 Sep 17;106(12):1505-9. doi: 10.1161/01.cir.0000029746.10018.36.

  PMID: 12234956 BACKGROUND

• 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. doi: 10.1177/152660280301000322.

  PMID: 12932168 BACKGROUND

• 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. doi: 10.1097/01.RVI.0000244868.65867.FB.

  PMID: 17185696 BACKGROUND

• 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. doi: 10.1007/s10439-005-9044-x. Epub 2006 Apr 18.

  PMID: 16619131 BACKGROUND

• Grassl ED, Bischof JC. In vitro model systems for evaluation of smooth muscle cell response to cryoplasty. Cryobiology. 2005 Apr;50(2):162-73. doi: 10.1016/j.cryobiol.2005.01.002.

  PMID: 15843006 BACKGROUND

• 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. doi: 10.1097/01.RVI.0000167866.86201.4E.

  PMID: 16105918 BACKGROUND

• Banerjee S, Das TS, Abu-Fadel MS, Dippel EJ, Shammas NW, Tran DL, Zankar A, Varghese C, Kelly KC, Weideman RA, Little BB, Reilly RF, Addo T, Brilakis ES. Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial. J Am Coll Cardiol. 2012 Oct 9;60(15):1352-9. doi: 10.1016/j.jacc.2012.05.042. Epub 2012 Sep 12.

  PMID: 22981558 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Subhash Banerjee, MD

  VA North Texas Healthcare Systen, Dallas, TX

  PRINCIPAL INVESTIGATOR

• Emmanouil S Brilakis, MD, PhD

  VA North Texas Healtcare System, Dallas, TX

  STUDY DIRECTOR

• Tony S Das, MD

  Texas Health Resources

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiology

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: November 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: February 1, 2012
• Last Updated: November 4, 2013

Record last verified: 2013-11

Locations

US (4)