Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease
NCT ID: NCT00827853
Last Updated: 2013-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2008-11-30
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Conventional angioplasty balloon post-dilation of nitinol self expanding stents
Conventional angioplasty balloon
Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using conventional angioplasty balloon
2
Cryoplasty balloon post-dilation
cryoplasty balloon
Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using cryoplasty balloon
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Conventional angioplasty balloon
Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using conventional angioplasty balloon
cryoplasty balloon
Post-dilation of clinically indicated nitinol self-expanding stents in the SFA using cryoplasty balloon
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
North Texas Veterans Healthcare System
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Subhash Banerjee
Chief of Cardiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Subhash Banerjee, MD
Role: PRINCIPAL_INVESTIGATOR
VA North Texas Healthcare Systen, Dallas, TX
Emmanouil S Brilakis, MD, PhD
Role: STUDY_DIRECTOR
VA North Texas Healtcare System, Dallas, TX
Tony S Das, MD
Role: STUDY_DIRECTOR
Texas Health Resources
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
VA Medical Center
Oklahoma City, Oklahoma, United States
Dallas Veterans Hospital
Dallas, Texas, United States
Dallas Presbyterian Hospital
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BOSTON SCI R&E 9-21-07#2
Identifier Type: -
Identifier Source: org_study_id