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Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia

CompletedNot applicableNCT02060630
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

Study details

Official title
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Interventions
  • Procedure: Open surgical revascularization
  • Device: Endovascular revascularization
Sponsor
Carelon Research
Collaborators
Brigham and Women's Hospital; Massachusetts General Hospital; Boston Medical Center; National Heart, Lung, and Blood Institute (NHLBI); Abbott; Bard Ltd; Boston Scientific Corporation; Cordis US Corp.; Abbott Medical Devices; Canadian Society for Vascular Surgery; Eastern Vascular Society; W.L.Gore & Associates; Midwest Vascular Society; New England Society for Vascular Surgery; Society for Clinical Vascular Surgery; Society for Interventional Radiology; Southern Vascular Society; Society for Vascular Medicine; Society for Vascular Surgery; Vascular and Endovascular Surgery Society; Vascular Interventional Advances; Western Vascular Society
Start date
2014-08
Primary completion
2022-03-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Canada, Finland, Italy, New Zealand, United States
Total sites listed
161

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Male or female, age 18 years or older. 2. Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament). 3. CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6. 4. Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators 5. Adequate aortoiliac inflow. 6. Adequate popliteal, tibial or pedal revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass. 7. Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent. Exclusion Criteria: 1. Presence of a popliteal aneurysm (\>2 cm) in the index limb. 2. Life expectancy of less than 2 years due to reasons other than PAOD. 3. Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team) 4. Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure. 5. Active vasculitis, Buerger's disease, or acute limb-threatening ischemia 6. Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis within 1 cm of stent or stent-graft, unless the occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial vessel that is not currently intended to be revascularized as a part of the treatment for CLI). 7. Any of the following procedures performed on the index limb within 3 months prior to enrollment: 1. Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft; 2. Infrainguinal bypass with either venous or prosthetic conduit 8. Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment 9. Current chemotherapy or radiation therapy. 10. Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) which would preclude patient participation in angiographic procedures. 11. Pregnancy or lactation. 12. Administration of an investigational drug for PAD within 30 days of randomization. 13. Participation in a clinical trial (except observational studies) within the previous 30 days. 14. Prior enrollment or randomization into BEST-CLI.

Canadian sites (12)

FacilityCityProvince
Vancouver General HospitalVancouverBritish Columbia
St. Boniface General HospitalWinnipegManitoba
Queen Elizabeth II Health Science CenterHalifaxNova Scotia
University of Western OntarioLondonOntario
The Ottawa HospitalOttawaOntario
Sunnybrook Health Sciences CentreTorontoOntario
Toronto General HospitalTorontoOntario
Jewish General HostpitalMontrealQuebec
McGillMontrealQuebec
Chu de QuebecQuébecQuebec
Regina Qu'AppelleReginaSaskatchewan
St. Paul's HospitalSaskatoonSaskatchewan
Canadian sites for NCT02060630VancouverWinnipegHalifaxLondonOttawaTorontoMontrealQuébec
Canadian sites for NCT02060630. 10 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02060630