The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
NCT ID: NCT03551496
Last Updated: 2024-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
201 participants
INTERVENTIONAL
2018-08-31
2023-12-20
Brief Summary
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Detailed Description
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Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DES BTK
Treatment with DES BTK
Drug Eluting Stent - Below the Knee
Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm
Conventional PTA
Treatment with standard PTA
Standard PTA Control Arm
The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Interventions
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Drug Eluting Stent - Below the Knee
Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm
Standard PTA Control Arm
The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Eligibility Criteria
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Inclusion Criteria
2. Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
3. Subject has chronic, symptomatic lower limb ischemia, determined by Rutherford categories 4 or 5 in the target limb, with wound(s) confined to toes/forefoot
4. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
1. Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
2. Target lesion(s) must be at least 4cm above the ankle joint
3. A single target lesion per vessel, in up to 2 vessels, in a single limb
4. Degree of stenosis ≥ 70% by visual angiographic assessment
5. Reference vessel diameter is between 2.5 - 3.25mm for phase A RCT
6. Total target lesion length (or series of lesion segments) to be treated is ≤ 70 mm for phase A RCT prior to the data monitoring committee's approval for stent overlap. (Note: Lesion segment(s) must be fully covered with one DES BTK stent, if randomized to stent)
7. Total target lesion length (or series of lesion segments) to be treated is ≤ 140 mm for phase A RCT after the data monitoring committee's approval for stent overlap (Note: Lesion segment(s) must be fully covered with up to two DES BTK stents, if randomized to stent)
8. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint)
9. Target lesion(s) is located in an area that may be stented without blocking access to patent main branches
10. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
11. Guidewire has successfully crossed the target lesion(s)
Exclusion Criteria
2. Stroke ≤ 90 days prior to the procedure date
3. Prior or planned major amputation in the target limb
4. Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
5. Previously implanted stent in the target vessel(s)
6. Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date
7. Renal failure as measured by a GFR ≤ 30ml/min per 1.73m2, measured ≤ 30 days prior to the procedure date
8. Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date
9. NYHA class IV heart failure
10. Subject has symptomatic coronary artery disease (ie, unstable angina)
11. History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date
12. Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis)
13. Subject is currently taking Canagliflozin
14. Body Mass Index (BMI) \<18
15. Active septicemia or bacteremia
16. Coagulation disorder, including hypercoagulability
17. Contraindication to anticoagulation or antiplatelet therapy
18. Known allergies to stent or stent components
19. Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure
20. Known hypersensitivity to heparin
21. Subject is on a high dose of steroids or is on immunosuppressive therapy
22. Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team)
1. Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism
2. Treatment required in \> 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel)
3. Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)
4. Aneurysm is present in the target vessel(s)
5. Extremely calcified lesions
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jihad Mustapha, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Cardiac & Vascular Centers for Amputation Prevention
Hendrik van Overhagen, MD
Role: PRINCIPAL_INVESTIGATOR
HAGA Ziekenhuis (HagaZiekenhuis van Den Haag)
Patrick Geraghty, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Masato Nakamura, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Toho University Ohashi Medical Center - Division of Cardiovascular Medicine
Locations
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St. Bernards Medical Center
Jonesboro, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
University of California, San Francisco
San Francisco, California, United States
Colorado VA
Denver, Colorado, United States
Bradenton Cardiology
Bradenton, Florida, United States
Willis Knighton Bossier Medical Center - Grace Research, LLC
Bossier City, Louisiana, United States
Cardiovascular Institute of the South Clinical Research Corporation
Houma, Louisiana, United States
Advanced Cardiac & Vascular Centers for Amputation Prevention
Grand Rapids, Michigan, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
New Mexico Heart Institute, PA
Albuquerque, New Mexico, United States
New York University Medical Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Amputation Prevention Center of North Carolina
Cary, North Carolina, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States
Wake Medical Center
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital
Erie, Pennsylvania, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Heart Hospital of Austin
Austin, Texas, United States
Texas Tech University Health
Lubbock, Texas, United States
THR Presbyterian Plano
Plano, Texas, United States
AZ Sint-Blasius
Dendermonde, , Belgium
ZOL Genk (Ziekenhuis Oost-Limburg)
Genk, , Belgium
UZ Gent (Universitair Ziekenhuis Gent)
Ghent, , Belgium
CHU Nantes
Nantes, , France
Hopital Paris Saint Joseph
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Clinique Pasteur
Toulouse, , France
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu-shi, Chiba, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Asahikawa Medical University Hospital
Asahikawa-shi, Hokkaido, Japan
Kansai Rosai Hospital
Amagasaki, Hyōgo, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Tokyo Medical and Dental University, Medical Hospital
Bunkyō-Ku, Tokyo, Japan
Toho University Ohashi Medical Center
Meguro City, Tokyo, Japan
HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag)
The Hague, , Netherlands
Countries
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References
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Kolte D, Kennedy KF, Shishehbor MH, Abbott JD, Khera S, Soukas P, Mamdani ST, Hyder ON, Drachman DE, Aronow HD. Thirty-Day Readmissions After Endovascular or Surgical Therapy for Critical Limb Ischemia: Analysis of the 2013 to 2014 Nationwide Readmissions Databases. Circulation. 2017 Jul 11;136(2):167-176. doi: 10.1161/CIRCULATIONAHA.117.027625. Epub 2017 May 2.
Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.
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Spreen MI, Martens JM, Hansen BE, Knippenberg B, Verhey E, van Dijk LC, de Vries JP, Vos JA, de Borst GJ, Vonken EJ, Wever JJ, Statius van Eps RG, Mali WP, van Overhagen H. Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial. Circ Cardiovasc Interv. 2016 Feb;9(2):e002376. doi: 10.1161/CIRCINTERVENTIONS.114.002376.
Kinlay S. Management of Critical Limb Ischemia. Circ Cardiovasc Interv. 2016 Feb;9(2):e001946. doi: 10.1161/CIRCINTERVENTIONS.115.001946.
Elsayed S, Clavijo LC. Critical limb ischemia. Cardiol Clin. 2015 Feb;33(1):37-47. doi: 10.1016/j.ccl.2014.09.008.
Conte MS. Critical appraisal of surgical revascularization for critical limb ischemia. J Vasc Surg. 2013 Feb;57(2 Suppl):8S-13S. doi: 10.1016/j.jvs.2012.05.114.
Gray BH, Diaz-Sandoval LJ, Dieter RS, Jaff MR, White CJ; Peripheral Vascular Disease Committee for the Society for Cardiovascular Angiography and Interventions. SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):539-45. doi: 10.1002/ccd.25395. Epub 2014 Jul 18.
Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5.
Popplewell MA, Davies HOB, Narayanswami J, Renton M, Sharp A, Bate G, Patel S, Deeks J, Bradbury AW. A Comparison of Outcomes in Patients with Infrapopliteal Disease Randomised to Vein Bypass or Plain Balloon Angioplasty in the Bypass vs. Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial. Eur J Vasc Endovasc Surg. 2017 Aug;54(2):195-201. doi: 10.1016/j.ejvs.2017.04.020. Epub 2017 Jun 8.
Sadaghianloo N, Jean-Baptiste E, Declemy S, Mousnier A, Brizzi S, Hassen-Khodja R. Percutaneous angioplasty of long tibial occlusions in critical limb ischemia. Ann Vasc Surg. 2013 Oct;27(7):894-903. doi: 10.1016/j.avsg.2013.02.008.
Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.
Spreen MI, Martens JM, Knippenberg B, van Dijk LC, de Vries JPM, Vos JA, de Borst GJ, Vonken EPA, Bijlstra OD, Wever JJ, Statius van Eps RG, Mali WPTM, van Overhagen H. Long-Term Follow-up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia. J Am Heart Assoc. 2017 Apr 14;6(4):e004877. doi: 10.1161/JAHA.116.004877.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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S2348
Identifier Type: -
Identifier Source: org_study_id
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