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Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia (BEST-CLI)

Primary Purpose

Critical Limb Ischemia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Open surgical revascularization
Endovascular revascularization
Sponsored by
Carelon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Surgical revascularization, Endovascular revascularization, Amputation, Peripheral artery disease, Critical limb ischemia, claudication, leg pain, leg ulcer, gangrene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Alabama at Birmingham
  • Arizona Heart Hospital
  • University of Arizona - Banner University Medical Center
  • Carondelet Heart & Vascular Institute
  • University of Arkansas for Medical Services
  • University of California - Irvine
  • San Diego VAMC
  • UC San Diego Sulpizio Cardiovascular Center
  • Loma Linda University Medical Center
  • Loma Linda VA Medical Center
  • VA Long Beach Healthcare System
  • Kaiser Permanente Los Angeles Medical Center
  • VA Greater Los Angeles
  • Keck Medical Center of USC
  • UCLA-Gonda Vascular Surgery
  • VA Palo Alto Health Care
  • Sacramento VA Medical Center
  • University of California Davis Medical Center
  • Kaiser Permanente (San Diego)
  • Kaiser Permanente Northern California
  • San Francisco Veterans Affairs Medical Center
  • University of California-San Francisco Medical Center
  • Stanford Hospital
  • Harbor - UCLA Medical Center
  • University of Colorado Hospital
  • Denver Health
  • Vascular Institute of the Rockies
  • Rocky Mountain Regional VA
  • St. Francis Hospital and Medical Center
  • Yale-New Haven Hospital
  • West Haven VAMC
  • Medstar Washington Hospital Center
  • GW Medical Faculty Associates, Inc.
  • University of Florida (Gainesville)
  • Mount Sinai Miami
  • Baptist Hospital of Miami
  • Florida Hospital Ocala
  • Tampa General Hospital
  • Tampa VAMC
  • Emory University
  • Atlanta VA Medical Center
  • Kaiser Foundation Hospital
  • Central DuPage Hospital (Cadence)
  • Rush University Medical Center
  • University of Chicago Medicine
  • Decatur Memorial Hospital
  • Loyola University Medical Center
  • Southern Illinois University School of Medicine
  • Northwestern Memorial Hospital
  • Indiana University Medical School
  • Mercy Hospital Medical Center
  • Ochsner Medical Center
  • University Health System: LSU Health Sciences
  • Maine Medical Center
  • University of Maryland Medical System
  • Johns Hopkins Hospital
  • Loyola University Medical Center
  • MedStar Union Memorial Hospital
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Boston Medical Center
  • VA Boston Healthcare System
  • Beth Israel Deaconess Medical Center
  • Steward St. Elizabeth's Medical Center
  • South Shore Hospital
  • University of Massachusetts Medical School
  • VA Ann Arbor Healthcare System
  • Michigan Heart/St. Joseph Mercy Ann Arbor Hospital
  • University of Michigan Health System
  • Henry Ford Health System
  • Michigan Vascular Center
  • Spectrum Health
  • William Beaumont Hospital
  • Minneapolis Heart Hospital/Abbott Northwestern Hosp.
  • Minneapolis VAMC
  • Mayo Clinic
  • University of Missouri
  • Midwest Aortic Vascular Institute
  • St. Louis VA Medical Center
  • University of Nebraska Medical Center
  • Dartmouth Hitchcock Medical Center
  • Deborah Heart and Lung Center
  • Englewood Hospital and Medical Center
  • Rutgers New Jersey Medical School
  • Holy Name Medical Center
  • New Mexico Heart Institute
  • New Mexico VA Medical Center
  • Albany Medical Center
  • Montefiore Medical Center
  • VA Western NY Healthcare System
  • Mount Sinai Medical Center
  • Columbia University Medical Center
  • Vascular Health Partners
  • University of Rochester Medical Center
  • Staten Island University Hospital
  • Stony Brook Medicine
  • SUNY Upstate Medical University
  • Westchester Medical Center
  • University of North Carolina
  • Duke University
  • Durham VAMC
  • North Carolina Heart and Vascular Research
  • Wake Forest Baptist Medical Center
  • University Hospitals of Cleveland/Case Western Reserve University
  • Cleveland Clinic Foundation
  • The Ohio State University
  • Ohio Health Research Institute
  • University of Toledo Medical Center
  • University of Oklahoma Health Sciences Center
  • University of Oklahoma College of Medicine at Tulsa
  • Providence Heart and Vascular Institute
  • Oregon Health and Science University
  • Portland VA Medical Center
  • Penn State Milton S. Hershey Medical Center
  • Temple University
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • Pinnacle Health System
  • Rhode Island Hospital
  • The Miriam Hospital/Brown Medical School
  • Medical University of South Carolina
  • Prisma Health-Upstate (Formerly Greenville Memorial Hospital)
  • North Central Heart Institute
  • Wellmont Holston Valley Medical Center
  • University of Tennessee Medical Center
  • Dallas VA Medical Center
  • Memorial Hermann Hospital TMC
  • Michael E. DeBakey VA Medical Center
  • Scott and White - Temple
  • The University of Utah
  • University of Vermont Medical Center
  • University of Virginia
  • Inova Fairfax Hospital
  • Sentara Vascular Specialists
  • Benaroya Research Institute at Virginia Mason
  • Harborview Medical Center
  • Swedish Medical Center
  • Providence Sacred Heart Medical Center
  • CAMC Clinical Trials Center
  • Gundersen Health System
  • University of Wisconsin-Madison
  • Meriter Wisconsin Heart
  • Medical College of Wisconsin
  • Milwaukee VAMC
  • Vancouver General Hospital
  • St. Boniface General Hospital
  • Queen Elizabeth II Health Science Center
  • University of Western Ontario
  • The Ottawa Hospital
  • Sunnybrook Health Sciences Centre
  • Toronto General Hospital
  • McGill
  • Jewish General Hostpital
  • Chu de Quebec
  • Regina Qu'Appelle
  • St. Paul's Hospital
  • Helsinki University Hospital
  • San Giovanni di Dio Hospital
  • Auckland City Hospital
  • Waikato Hospital
  • Wellington Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Available vein, open surg. revasc.

Available vein, endovasc. revasc.

Alternative conduit, open surg. revasc.

Alternative conduit, endovasc. revasc.

Arm Description

Subjects with an available SSGSV cohort randomized to open surgical revascularization

Subjects with an available SSGSV cohort randomized to endovascular revascularization

Subjects with an alternative conduit cohort randomized to open surgical revascularization

Subjects with an alternative conduit cohort randomized to endovascular revascularization

Outcomes

Primary Outcome Measures

The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)
Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV

Secondary Outcome Measures

Clinical: Re-intervention and amputation-free survival (cohort 1)
Time to re-intervention of the index leg, above ankle amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available
Clinical: Re-intervention and amputation-free survival (cohort 2)
Time to re-intervention of the index leg, above ankle amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV
Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)
Time to re-intervention of the index leg, amputation of the index leg, or death within 30 days of index procedure, whichever occurs first in subjects with SSGSV available
Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2)
Time to re-intervention of the index leg, amputation of the index leg, or death within 30 days of index procedure, whichever occurs first in subjects without available SSGSV
Clinical: Amputation-free survival (cohort 1)
Time to amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available
Clinical: Amputation-free survival (cohort 2)
Time to amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV
Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1)
Time to death within 30 days of index procedure in subjects with SSGSV available
Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2)
Time to death within 30 days of index procedure in subjects without available SSGSV
Clinical: Freedom from Myocardial Infarction (cohort 1)
Time to myocardial infarction (MI) in subjects with SSGSV available
Clinical: Freedom from Myocardial Infarction (cohort 2)
Time to myocardial infarction (MI) in subjects without available SSGSV
Clinical: Freedom from Stroke (cohort 1)
Time to stroke in subjects with SSGSV available
Clinical: Freedom from Stroke (cohort 2)
Time to stroke in subjects without available SSGSV
Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1)
Time to re-intervention (major and minor) in index leg in subjects with SSGSV available
Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2)
Time to re-intervention (major and minor) in index leg in subjects without available SSGSV
Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1)
Number of re-interventions (major and minor) in per limb salvaged in subjects with SSGSV available
Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2)
Number of re-interventions (major and minor) in per limb salvaged in subjects without available SSGSV
Clinical: Freedom from hemodynamic failure (cohort 1)
Time to hemodynamic failure in subjects with SSGSV available
Clinical: Freedom from hemodynamic failure (cohort 2)
Time to hemodynamic failure in subjects without available SSGSV
Clinical: Freedom from clinical failure (cohort 1)
Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects with SSGSV available
Clinical: Freedom from clinical failure (cohort 2)
Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects without available SSGSV
Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1)
Time to resolution of presenting CLI symptoms in the index limb in subjects with SSGSV available
Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2)
Time to resolution of presenting CLI symptoms in the index limb in subjects without available SSGSV
Clinical: Freedom from all-cause mortality (cohort 1)
Time to all-cause mortality in subjects with SSGSV available
Clinical: Freedom from all-cause mortality (cohort 2)
Time to all-cause mortality in subjects without available SSGSV
Functional: Quality of Life assessment using VasuQoL (cohort 1)
VasuQOL measurements in subjects with SSGSV available
Functional: Quality of Life assessment using VasuQoL (cohort 2)
VasuQOL measurements in subjects without available SSGSV
Functional: Quality of Life assessment using EuroQoL (cohort 1)
EuroQOL measurements in subjects with SSGSV available
Functional: Quality of Life assessment using EuroQoL (cohort 2)
EuroQOL measurements in subjects without available SSGSV
Functional: Function assessment using SF-12, PCS (cohort 1)
Physical Component Summary (PCS) scores in subjects with SSGSV available
Functional: Function assessment using SF-12, PCS (cohort 2)
Physical Component Summary (PCS) scores in subjects without available SSGSV
Functional: Function assessment using SF-12, MCS (cohort 1)
Mental Component Summary (MCS) scores in subjects with SSGSV available
Functional: Function assessment using SF-12, MCS (cohort 2)
Mental Component Summary (MCS) scores in subjects without available SSGSV
Functional: Function assessment using SF-12, SF-6D R2 (cohort 1)
Utility Index (SF-6D R2) scores in subjects with SSGSV available
Functional: Function assessment using SF-12, SF-6D R2(cohort 2)
Utility Index (SF-6D R2) scores in subjects without available SSGSV
Functional: Numerical rating scale for Pain, Pain Now (cohort 1)
Scores for Pain Now in subjects with SSGSV available
Functional: Numerical rating scale for Pain, Pain Now (cohort 2)
Scores for Pain Now in subjects without available SSGSV
Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1)
Scores for Usual level of Pain during the last week in subjects with SSGSV available
Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2)
Scores for Usual level of Pain during the last week in subjects without available SSGSV
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1)
Scores for Best level of Pain during the last week in subjects with SSGSV available
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2)
Scores for Best level of Pain during the last week in subjects without available SSGSV
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1)
Scores for Worst level of Pain during the last week in subjects with SSGSV available
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2)
Scores for Worst level of Pain during the last week in subjects without available SSGSV
Function: Six-minute walk test (cohort 1)
Six-minute walk test measurements in subjects with SSGSV available. The six-minute walk test was performed at a subset of clinical sites (for whom this test was standard of care) and was limited to patients for whom rest pain, wounds, or foot surgery (recent or anticipated) did not preclude weight bearing
Function: Six-minute walk test (cohort 2)
Six-minute walk test measurements in subjects without available SSGSV. The six-minute walk test was performed at a subset of clinical sites (for whom this test was standard of care) and was limited to patients for whom rest pain, wounds, or foot surgery (recent or anticipated) did not preclude weight bearing

Full Information

First Posted
February 6, 2014
Last Updated
April 3, 2023
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 Corporation, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02060630
Brief Title
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
Acronym
BEST-CLI
Official Title
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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 Corporation, 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost effectiveness outcomes after treatment. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
Keywords
Surgical revascularization, Endovascular revascularization, Amputation, Peripheral artery disease, Critical limb ischemia, claudication, leg pain, leg ulcer, gangrene

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1843 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Available vein, open surg. revasc.
Arm Type
Other
Arm Description
Subjects with an available SSGSV cohort randomized to open surgical revascularization
Arm Title
Available vein, endovasc. revasc.
Arm Type
Other
Arm Description
Subjects with an available SSGSV cohort randomized to endovascular revascularization
Arm Title
Alternative conduit, open surg. revasc.
Arm Type
Other
Arm Description
Subjects with an alternative conduit cohort randomized to open surgical revascularization
Arm Title
Alternative conduit, endovasc. revasc.
Arm Type
Other
Arm Description
Subjects with an alternative conduit cohort randomized to endovascular revascularization
Intervention Type
Procedure
Intervention Name(s)
Open surgical revascularization
Intervention Type
Device
Intervention Name(s)
Endovascular revascularization
Intervention Description
A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.
Primary Outcome Measure Information:
Title
The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)
Description
Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary Outcome Measure Information:
Title
Clinical: Re-intervention and amputation-free survival (cohort 1)
Description
Time to re-intervention of the index leg, above ankle amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Re-intervention and amputation-free survival (cohort 2)
Description
Time to re-intervention of the index leg, above ankle amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)
Description
Time to re-intervention of the index leg, amputation of the index leg, or death within 30 days of index procedure, whichever occurs first in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2)
Description
Time to re-intervention of the index leg, amputation of the index leg, or death within 30 days of index procedure, whichever occurs first in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Amputation-free survival (cohort 1)
Description
Time to amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Amputation-free survival (cohort 2)
Description
Time to amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1)
Description
Time to death within 30 days of index procedure in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2)
Description
Time to death within 30 days of index procedure in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from Myocardial Infarction (cohort 1)
Description
Time to myocardial infarction (MI) in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from Myocardial Infarction (cohort 2)
Description
Time to myocardial infarction (MI) in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from Stroke (cohort 1)
Description
Time to stroke in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from Stroke (cohort 2)
Description
Time to stroke in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1)
Description
Time to re-intervention (major and minor) in index leg in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2)
Description
Time to re-intervention (major and minor) in index leg in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1)
Description
Number of re-interventions (major and minor) in per limb salvaged in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2)
Description
Number of re-interventions (major and minor) in per limb salvaged in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from hemodynamic failure (cohort 1)
Description
Time to hemodynamic failure in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from hemodynamic failure (cohort 2)
Description
Time to hemodynamic failure in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from clinical failure (cohort 1)
Description
Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from clinical failure (cohort 2)
Description
Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1)
Description
Time to resolution of presenting CLI symptoms in the index limb in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2)
Description
Time to resolution of presenting CLI symptoms in the index limb in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from all-cause mortality (cohort 1)
Description
Time to all-cause mortality in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Clinical: Freedom from all-cause mortality (cohort 2)
Description
Time to all-cause mortality in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Quality of Life assessment using VasuQoL (cohort 1)
Description
VasuQOL measurements in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Quality of Life assessment using VasuQoL (cohort 2)
Description
VasuQOL measurements in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Quality of Life assessment using EuroQoL (cohort 1)
Description
EuroQOL measurements in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Quality of Life assessment using EuroQoL (cohort 2)
Description
EuroQOL measurements in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Function assessment using SF-12, PCS (cohort 1)
Description
Physical Component Summary (PCS) scores in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Function assessment using SF-12, PCS (cohort 2)
Description
Physical Component Summary (PCS) scores in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Function assessment using SF-12, MCS (cohort 1)
Description
Mental Component Summary (MCS) scores in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Function assessment using SF-12, MCS (cohort 2)
Description
Mental Component Summary (MCS) scores in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Function assessment using SF-12, SF-6D R2 (cohort 1)
Description
Utility Index (SF-6D R2) scores in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Function assessment using SF-12, SF-6D R2(cohort 2)
Description
Utility Index (SF-6D R2) scores in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Numerical rating scale for Pain, Pain Now (cohort 1)
Description
Scores for Pain Now in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Numerical rating scale for Pain, Pain Now (cohort 2)
Description
Scores for Pain Now in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1)
Description
Scores for Usual level of Pain during the last week in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2)
Description
Scores for Usual level of Pain during the last week in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1)
Description
Scores for Best level of Pain during the last week in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2)
Description
Scores for Best level of Pain during the last week in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1)
Description
Scores for Worst level of Pain during the last week in subjects with SSGSV available
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2)
Description
Scores for Worst level of Pain during the last week in subjects without available SSGSV
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Function: Six-minute walk test (cohort 1)
Description
Six-minute walk test measurements in subjects with SSGSV available. The six-minute walk test was performed at a subset of clinical sites (for whom this test was standard of care) and was limited to patients for whom rest pain, wounds, or foot surgery (recent or anticipated) did not preclude weight bearing
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Title
Function: Six-minute walk test (cohort 2)
Description
Six-minute walk test measurements in subjects without available SSGSV. The six-minute walk test was performed at a subset of clinical sites (for whom this test was standard of care) and was limited to patients for whom rest pain, wounds, or foot surgery (recent or anticipated) did not preclude weight bearing
Time Frame
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age 18 years or older. Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament). CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6. Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators Adequate aortoiliac inflow. 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. Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent. Exclusion Criteria: Presence of a popliteal aneurysm (>2 cm) in the index limb. Life expectancy of less than 2 years due to reasons other than PAOD. Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team) Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure. Active vasculitis, Buerger's disease, or acute limb-threatening ischemia 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). Any of the following procedures performed on the index limb within 3 months prior to enrollment: Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft; Infrainguinal bypass with either venous or prosthetic conduit Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment Current chemotherapy or radiation therapy. 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. Pregnancy or lactation. Administration of an investigational drug for PAD within 30 days of randomization. Participation in a clinical trial (except observational studies) within the previous 30 days. Prior enrollment or randomization into BEST-CLI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Menard, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alik Farber, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Rosenfield, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Cziraky, PharmD, CLS
Organizational Affiliation
Carelon Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taye Hamza, PhD
Organizational Affiliation
Carelon Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
University of Arizona - Banner University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Carondelet Heart & Vascular Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
University of Arkansas for Medical Services
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California - Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
San Diego VAMC
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Sulpizio Cardiovascular Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Loma Linda VA Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
VA Greater Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
UCLA-Gonda Vascular Surgery
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
VA Palo Alto Health Care
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Sacramento VA Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente (San Diego)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente Northern California
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
San Francisco Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
University of California-San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Harbor - UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80024
Country
United States
Facility Name
Vascular Institute of the Rockies
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Regional VA
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
St. Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
West Haven VAMC
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
GW Medical Faculty Associates, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Florida (Gainesville)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mount Sinai Miami
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Hospital Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Tampa VAMC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Kaiser Foundation Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Central DuPage Hospital (Cadence)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
601611
Country
United States
Facility Name
Indiana University Medical School
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mercy Hospital Medical Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University Health System: LSU Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21210
Country
United States
Facility Name
Loyola University Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21210
Country
United States
Facility Name
MedStar Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
VA Boston Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Steward St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
South Shore Hospital
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02189
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Michigan Heart/St. Joseph Mercy Ann Arbor Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Michigan Vascular Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Minneapolis Heart Hospital/Abbott Northwestern Hosp.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Minneapolis VAMC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Midwest Aortic Vascular Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
St. Louis VA Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Hanover
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New Mexico VA Medical Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
VA Western NY Healthcare System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Vascular Health Partners
City
Queensbury
State/Province
New York
ZIP/Postal Code
12804
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Stony Brook Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8191
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13215
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Durham VAMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
North Carolina Heart and Vascular Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals of Cleveland/Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Oklahoma College of Medicine at Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Providence Heart and Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Pinnacle Health System
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
The Miriam Hospital/Brown Medical School
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Prisma Health-Upstate (Formerly Greenville Memorial Hospital)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
North Central Heart Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Memorial Hermann Hospital TMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott and White - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
The University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Vascular Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Benaroya Research Institute at Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Providence Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
CAMC Clinical Trials Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
Facility Name
Meriter Wisconsin Heart
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53713
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Milwaukee VAMC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Queen Elizabeth II Health Science Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3A7
Country
Canada
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
McGill
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada
Facility Name
Jewish General Hostpital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Chu de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1L 3L5
Country
Canada
Facility Name
Regina Qu'Appelle
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada
Facility Name
St. Paul's Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M0Z9
Country
Canada
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
F100029
Country
Finland
Facility Name
San Giovanni di Dio Hospital
City
Florence
ZIP/Postal Code
50124
Country
Italy
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36342173
Citation
Farber A, Menard MT, Conte MS, Kaufman JA, Powell RJ, Choudhry NK, Hamza TH, Assmann SF, Creager MA, Cziraky MJ, Dake MD, Jaff MR, Reid D, Siami FS, Sopko G, White CJ, van Over M, Strong MB, Villarreal MF, McKean M, Azene E, Azarbal A, Barleben A, Chew DK, Clavijo LC, Douville Y, Findeiss L, Garg N, Gasper W, Giles KA, Goodney PP, Hawkins BM, Herman CR, Kalish JA, Koopmann MC, Laskowski IA, Mena-Hurtado C, Motaganahalli R, Rowe VL, Schanzer A, Schneider PA, Siracuse JJ, Venermo M, Rosenfield K; BEST-CLI Investigators. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med. 2022 Dec 22;387(25):2305-2316. doi: 10.1056/NEJMoa2207899. Epub 2022 Nov 7.
Results Reference
derived
PubMed Identifier
33825577
Citation
Albaghdadi MS, Young MN, Chowdhury MM, Assmann S, Hamza T, Siami S, Villarreal M, Strong M, Menard M, Farber A, Rosenfield K. Clinical practice patterns and ascertainment bias for cardiovascular events in a randomized trial: A survey of investigators in the BEST-CLI trial. Vasc Med. 2021 Apr;26(2):180-186. doi: 10.1177/1358863X21995897.
Results Reference
derived
PubMed Identifier
33314979
Citation
Rathakrishnan B, Secemsky EA. Turning the tide: Evolution of below-the-knee endovascular intervention. Vasc Med. 2021 Feb;26(1):26-27. doi: 10.1177/1358863X20978281. Epub 2020 Dec 14. No abstract available.
Results Reference
derived
PubMed Identifier
31010516
Citation
Powell R, Menard M, Farber A, Rosenfield K, Goodney P, Gray B, Lookstein R, Pena C, Schermerhorn M. Comparison of specialties participating in the BEST-CLI trial to specialists treating peripheral arterial disease nationally. J Vasc Surg. 2019 May;69(5):1505-1509. doi: 10.1016/j.jvs.2018.08.188.
Results Reference
derived
PubMed Identifier
30683195
Citation
Farber A, Rosenfield K, Siami FS, Strong M, Menard M. The BEST-CLI trial is nearing the finish line and promises to be worth the wait. J Vasc Surg. 2019 Feb;69(2):470-481.e2. doi: 10.1016/j.jvs.2018.05.255.
Results Reference
derived
PubMed Identifier
27402237
Citation
Menard MT, Farber A, Assmann SF, Choudhry NK, Conte MS, Creager MA, Dake MD, Jaff MR, Kaufman JA, Powell RJ, Reid DM, Siami FS, Sopko G, White CJ, Rosenfield K. Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial. J Am Heart Assoc. 2016 Jul 8;5(7):e003219. doi: 10.1161/JAHA.116.003219.
Results Reference
derived

Learn more about this trial

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

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