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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HL107407 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
| Boston Medical Center | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Available vein, open surg. revasc. | Other | Subjects with an available SSGSV cohort randomized to open surgical revascularization |
|
| Available vein, endovasc. revasc. | Other | Subjects with an available SSGSV cohort randomized to endovascular revascularization |
|
| Alternative conduit, open surg. revasc. | Other | Subjects with an alternative conduit cohort randomized to open surgical revascularization |
|
| Alternative conduit, endovasc. revasc. | Other | Subjects with an alternative conduit cohort randomized to endovascular revascularization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open surgical revascularization | Procedure |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Menard, MD | Brigham and Women's Hospital | Principal Investigator |
| Alik Farber, MD | Boston University | Principal Investigator |
| Kenneth Rosenfield, MD | Massachusetts General Hospital | Principal Investigator |
| Mark Cziraky, PharmD, CLS | Carelon Research | Principal Investigator |
| Taye Hamza, PhD | Carelon Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Arizona Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41534992 | Derived | Hicks CW, Farber A, Doros G, Kinlay S, Powell RJ, Strong MB, Rosenfield K, Aridi H, Motaganahalli R, Barleben A, Siracuse JJ, Azene E, Malas M, Conte MS, Zayed M, Menard MT. Atherectomy Is Not Associated With Improved Limb-Based Outcomes Among Patients in the BEST-CLI Trial Undergoing Endovascular Revascularization. JACC Cardiovasc Interv. 2026 Jan 12;19(1):96-107. doi: 10.1016/j.jcin.2025.10.065. | |
| 41453560 | Derived | Venermo MA, de Vega M, Houlind K, Siracuse JJ, Doros G, Kiang S, Barshes N, Rosenfield K, Menard MT, Farber A; BEST-CLI haemodynamic working group. Baseline Haemodynamic Measurements and Immediate Change in Parameters after Revascularisation: Ankle Pressure, Ankle Brachial Index, Toe Pressure, and Toe Brachial Index Analysis of the BEST-CLI Participants. Eur J Vasc Endovasc Surg. 2026 Jun;71(6):942-949. doi: 10.1016/j.ejvs.2025.12.042. Epub 2025 Dec 24. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 18, 2025 | |
| Reset | Mar 10, 2025 |
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| NIH |
| Abbott | INDUSTRY |
| Bard Ltd | INDUSTRY |
| Boston Scientific Corporation | INDUSTRY |
| Cordis US Corp. | INDUSTRY |
| Abbott Medical Devices | INDUSTRY |
| Canadian Society for Vascular Surgery | UNKNOWN |
| Eastern Vascular Society | UNKNOWN |
| W.L.Gore & Associates | INDUSTRY |
| Midwest Vascular Society | UNKNOWN |
| New England Society for Vascular Surgery | UNKNOWN |
| Society for Clinical Vascular Surgery | UNKNOWN |
| Society for Interventional Radiology | UNKNOWN |
| Southern Vascular Society | UNKNOWN |
| Society for Vascular Medicine | UNKNOWN |
| Society for Vascular Surgery | OTHER |
| Vascular and Endovascular Surgery Society | UNKNOWN |
| Vascular Interventional Advances | UNKNOWN |
| Western Vascular Society | UNKNOWN |
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| Endovascular revascularization |
| Device |
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. |
|
| 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 |
| Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Amputation-free survival (cohort 1) | Time to amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Amputation-free survival (cohort 2) | Time to amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Freedom from Myocardial Infarction (cohort 1) | Time to myocardial infarction (MI) in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Freedom from Myocardial Infarction (cohort 2) | Time to myocardial infarction (MI) in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Freedom from Stroke (cohort 1) | Time to stroke in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Freedom from Stroke (cohort 2) | Time to stroke in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Freedom from hemodynamic failure (cohort 1) | Time to hemodynamic failure in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Freedom from hemodynamic failure (cohort 2) | Time to hemodynamic failure in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Freedom from all-cause mortality (cohort 1) | Time to all-cause mortality in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Clinical: Freedom from all-cause mortality (cohort 2) | Time to all-cause mortality in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Quality of Life assessment using VasuQoL (cohort 1) | VasuQOL measurements in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Quality of Life assessment using VasuQoL (cohort 2) | VasuQOL measurements in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Quality of Life assessment using EuroQoL (cohort 1) | EuroQOL measurements in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Quality of Life assessment using EuroQoL (cohort 2) | EuroQOL measurements in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Function assessment using SF-12, PCS (cohort 1) | Physical Component Summary (PCS) scores in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Function assessment using SF-12, PCS (cohort 2) | Physical Component Summary (PCS) scores in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Function assessment using SF-12, MCS (cohort 1) | Mental Component Summary (MCS) scores in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Function assessment using SF-12, MCS (cohort 2) | Mental Component Summary (MCS) scores in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Function assessment using SF-12, SF-6D R2 (cohort 1) | Utility Index (SF-6D R2) scores in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Function assessment using SF-12, SF-6D R2(cohort 2) | Utility Index (SF-6D R2) scores in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Numerical rating scale for Pain, Pain Now (cohort 1) | Scores for Pain Now in subjects with SSGSV available | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Functional: Numerical rating scale for Pain, Pain Now (cohort 2) | Scores for Pain Now in subjects without available SSGSV | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| 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 | Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| University of Arizona - Banner University Medical Center | Tucson | Arizona | 85719 | United States |
| Carondelet Heart & Vascular Institute | Tucson | Arizona | 85745 | United States |
| University of Arkansas for Medical Services | Little Rock | Arkansas | 72205 | United States |
| University of California - Irvine | Irvine | California | 92697 | United States |
| San Diego VAMC | La Jolla | California | 92037 | United States |
| UC San Diego Sulpizio Cardiovascular Center | La Jolla | California | 92037 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Loma Linda VA Medical Center | Loma Linda | California | 92357 | United States |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| VA Greater Los Angeles | Los Angeles | California | 90073 | United States |
| Keck Medical Center of USC | Los Angeles | California | 90089 | United States |
| UCLA-Gonda Vascular Surgery | Los Angeles | California | 90095 | United States |
| VA Palo Alto Health Care | Palo Alto | California | 94304 | United States |
| Sacramento VA Medical Center | Sacramento | California | 95655 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| Kaiser Permanente (San Diego) | San Diego | California | 92123 | United States |
| Kaiser Permanente Northern California | San Francisco | California | 94118 | United States |
| San Francisco Veterans Affairs Medical Center | San Francisco | California | 94121 | United States |
| University of California-San Francisco Medical Center | San Francisco | California | 94143 | United States |
| Stanford Hospital | Stanford | California | 94305 | United States |
| Harbor - UCLA Medical Center | Torrance | California | 90509 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Denver Health | Denver | Colorado | 80024 | United States |
| Vascular Institute of the Rockies | Denver | Colorado | 80218 | United States |
| Rocky Mountain Regional VA | Denver | Colorado | 80220 | United States |
| St. Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| West Haven VAMC | West Haven | Connecticut | 06516 | United States |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| GW Medical Faculty Associates, Inc. | Washington D.C. | District of Columbia | 20037 | United States |
| University of Florida (Gainesville) | Gainesville | Florida | 32610 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Mount Sinai Miami | Miami Springs | Florida | 33140 | United States |
| Florida Hospital Ocala | Ocala | Florida | 34471 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Tampa VAMC | Tampa | Florida | 33612 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Kaiser Foundation Hospital | Honolulu | Hawaii | 96819 | United States |
| Central DuPage Hospital (Cadence) | Chicago | Illinois | 60190 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Northwestern Memorial Hospital | Winfield | Illinois | 601611 | United States |
| Indiana University Medical School | Indianapolis | Indiana | 46202 | United States |
| Mercy Hospital Medical Center | West Des Moines | Iowa | 50266 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| University Health System: LSU Health Sciences | Shreveport | Louisiana | 71130 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| University of Maryland Medical System | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21210 | United States |
| Loyola University Medical Center | Baltimore | Maryland | 21210 | United States |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| VA Boston Healthcare System | Boston | Massachusetts | 02132 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Steward St. Elizabeth's Medical Center | Brighton | Massachusetts | 02135 | United States |
| South Shore Hospital | Weymouth | Massachusetts | 02189 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States |
| Michigan Heart/St. Joseph Mercy Ann Arbor Hospital | Ann Arbor | Michigan | 48106 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Michigan Vascular Center | Flint | Michigan | 48507 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Minneapolis Heart Hospital/Abbott Northwestern Hosp. | Minneapolis | Minnesota | 55407 | United States |
| Minneapolis VAMC | Minneapolis | Minnesota | 55417 | United States |
| Mayo Clinic | Rochester | Minnesota | 55901 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Midwest Aortic Vascular Institute | Kansas City | Missouri | 64116 | United States |
| St. Louis VA Medical Center | St Louis | Missouri | 63106 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Dartmouth Hitchcock Medical Center | Hanover | New Hampshire | 03756 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | United States |
| New Mexico VA Medical Center | Albuquerque | New Mexico | 87108 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| VA Western NY Healthcare System | Buffalo | New York | 14215 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Vascular Health Partners | Queensbury | New York | 12804 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| Stony Brook Medicine | Stony Brook | New York | 11794-8191 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13215 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Durham VAMC | Durham | North Carolina | 27705 | United States |
| North Carolina Heart and Vascular Research | Raleigh | North Carolina | 27607 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals of Cleveland/Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44109 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| University of Toledo Medical Center | Toledo | Ohio | 43615 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Oklahoma College of Medicine at Tulsa | Tulsa | Oklahoma | 74135 | United States |
| Providence Heart and Vascular Institute | Portland | Oregon | 97213 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Portland VA Medical Center | Portland | Oregon | 97239 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Pinnacle Health System | Wormleysburg | Pennsylvania | 17043 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02905 | United States |
| The Miriam Hospital/Brown Medical School | Providence | Rhode Island | 02906 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Prisma Health-Upstate (Formerly Greenville Memorial Hospital) | Greenville | South Carolina | 29605 | United States |
| North Central Heart Institute | Sioux Falls | South Dakota | 57108 | United States |
| Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37660 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75390 | United States |
| Memorial Hermann Hospital TMC | Houston | Texas | 77030 | United States |
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| Scott and White - Temple | Temple | Texas | 76508 | United States |
| The University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | United States |
| Benaroya Research Institute at Virginia Mason | Seattle | Washington | 98101 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| CAMC Clinical Trials Center | Charleston | West Virginia | 25304 | United States |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53706 | United States |
| Meriter Wisconsin Heart | Madison | Wisconsin | 53713 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Milwaukee VAMC | Milwaukee | Wisconsin | 53295 | United States |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z1M9 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Queen Elizabeth II Health Science Center | Halifax | Nova Scotia | B3H3A7 | Canada |
| University of Western Ontario | London | Ontario | N6A5W9 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1Y4E9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| McGill | Montreal | Quebec | H3A1A1 | Canada |
| Jewish General Hostpital | Montreal | Quebec | H3T 1E2 | Canada |
| Chu de Quebec | Québec | Quebec | G1L 3L5 | Canada |
| Regina Qu'Appelle | Regina | Saskatchewan | S4P 0W5 | Canada |
| St. Paul's Hospital | Saskatoon | Saskatchewan | S7M0Z9 | Canada |
| Helsinki University Hospital | Helsinki | F100029 | Finland |
| San Giovanni di Dio Hospital | Florence | 50124 | Italy |
| Auckland City Hospital | Grafton | Auckland | 1023 | New Zealand |
| Waikato Hospital | Hamilton | Waikato Region | 3240 | New Zealand |
| Wellington Hospital | Newtown | Wellington Region | 6021 | New Zealand |
| 41242623 | Derived | Tan TW, Dansey KD, Farber A, Doros G, Menard MT, Rosenfield K, Conte MS, Venermo M, Kolh P, Strong MB, Singh N. High rates of nonindex limb amputation in the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial. J Vasc Surg. 2026 Mar;83(3):905-913. doi: 10.1016/j.jvs.2025.11.009. Epub 2025 Nov 14. |
| 40886741 | Derived | Alameddine D, Hamouda M, Doros G, Conte MS, Rosenfield K, Strong MB, Menard MT, Farber A, Hamdan A, Malas M, Ochoa Chaar CI. Insulin therapy and outcomes of revascularization procedures for chronic limb-threatening ischemia in the BEST-CLI trial. J Vasc Surg. 2026 Jan;83(1):246-255.e3. doi: 10.1016/j.jvs.2025.08.033. Epub 2025 Aug 29. |
| 40885461 | Derived | Jones DW, Farber A, Armstrong DG, Azene E, Duncan A, Todoran TM, Doros G, Strong MB, Rosenfield K, Conte MS, Menard MT. Characteristics of multidisciplinary limb preservation teams and their impact on outcomes in the BEST-CLI trial. J Vasc Surg. 2026 Feb;83(2):528-538. doi: 10.1016/j.jvs.2025.08.028. Epub 2025 Aug 28. |
| 40484061 | Derived | Alonso A, Huang J, Oro CF, Maaneb de Macedo K, Lotfollahzadeh S, Kalish J, Farber A, King E, Chitalia VC, Siracuse JJ. Factors associated with cancellation of arteriovenous access creations. J Vasc Surg. 2025 Oct;82(4):1477-1484. doi: 10.1016/j.jvs.2025.05.211. Epub 2025 Jun 6. |
| 40464723 | Derived | Siracuse JJ, Kaufman JA, Farber A, Menard MT, Rosenfield K, Conte MS, Schanzer A, Powell RJ, Venermo M, Doros G, Faries P, Strong MB, Dake MD. Antiproliferative endovascular drug technology is associated with fewer major reinterventions after femoropopliteal interventions for chronic limb-threatening ischemia. J Vasc Surg. 2025 Oct;82(4):1375-1382. doi: 10.1016/j.jvs.2025.04.029. Epub 2025 Jun 4. |
| 40138771 | Derived | Ramkumar N, Goodney PP, Moore K, Goodney AJ, Ponukumati AS, Menard M, Farber A, Staiger D. Selecting Treatments for Peripheral Artery Disease: Differences Between Registry and a Randomized Controlled Trial Population. J Surg Res. 2025 Apr;308:286-294. doi: 10.1016/j.jss.2025.02.040. Epub 2025 Mar 25. |
| 40100950 | Derived | Conte MS, Farber A, Barleben A, Chisci E, Doros G, Kashyap VS, Kayssi A, Kolh P, Moreira CC, Nypaver T, Rosenfield K, Rowe VL, Schanzer A, Singh N, Siracuse JJ, Strong MB, Menard MT. Impact of Bypass Conduit and Early Technical Failure on Revascularization for Chronic Limb-Threatening Ischemia. Circ Cardiovasc Interv. 2025 Mar;18(3):e014716. doi: 10.1161/CIRCINTERVENTIONS.124.014716. Epub 2025 Mar 18. |
| 39984143 | Derived | Barleben AR, Patel RJ, Farber A, Menard MT, Venermo M, Creager MA, Reitz KM, Strong M, Rosenfield K, Doros G, Dake M, Chaer RA. An assessment of the BEST-CLI Trial demonstrates that infrainguinal bypass offers a potential advantage in smokers with chronic limb-threatening ischemia. J Vasc Surg. 2025 Jun;81(6):1411-1419.e1. doi: 10.1016/j.jvs.2025.02.015. Epub 2025 Feb 19. |
| 39923916 | Derived | Alonso A, Kobzeva-Herzog AJ, Levin SR, de Macedo KM, Melvin J, Farber A, King EG, Garg K, Shean KE, O'Donnell TFX, Rybin D, Siracuse JJ. Disability and associated outcomes among patients suffering periprocedural strokes after carotid artery stenting. J Vasc Surg. 2025 Jun;81(6):1343-1350. doi: 10.1016/j.jvs.2025.01.223. Epub 2025 Feb 7. |
| 39914761 | Derived | Ulloa JG, Alabi O, McGinigle K, Lane J, Doros G, Menard M, Moreira CC, Judelson DR, Farber A, Conte MS, Rosenfeld K, Hamouda M, Kirksey L, Strong MB, Malas M, Kernodle A, Rowe VL. Outcomes for Hispanic patients undergoing open bypass in BEST-CLI. J Vasc Surg. 2025 Jun;81(6):1420-1429. doi: 10.1016/j.jvs.2025.01.212. Epub 2025 Feb 4. |
| 39880293 | Derived | Alonso A, Kobzeva-Herzog A, Dalton-Petillo S, Haqqani M, Farber A, King EG, Hicks CW, Malas M, Garg K, Osborne N, Simons JP, Siracuse JJ. Evaluating the management of intermittent claudication before and after publication of the Society of Vascular Surgery's Appropriate Use Criteria. J Vasc Surg. 2025 Aug;82(2):526-533.e3. doi: 10.1016/j.jvs.2024.12.133. Epub 2025 Jan 27. |
| 39846933 | Derived | Malas MB, Hamouda M, Farber A, Menard MT, Conte MS, Rosenfield K, Strong MB, Doros G, Powell RJ, Mena-Hurtado C, Gasper W, Schermerhorn ML, Allievi S, Smolderen KG, Dake MD, Rymer JA, Tuttle KR. Outcomes of chronic limb-threatening ischemia revascularization in patients with chronic kidney disease in the BEST-CLI trial. J Vasc Surg. 2025 Apr;81(4):945-956.e3. doi: 10.1016/j.jvs.2024.12.128. Epub 2025 Jan 23. |
| 39638100 | Derived | Siracuse JJ, Farber A, Menard MT, Rosenfield K, Conte MS, Schanzer A, Doros G, Motaganahalli R, Laskowski IJ, Barshes NR, Genovese EA, Strong MB, Mills JL. Advanced Wound, Ischemia, and Foot Infection stage is associated with poor outcomes in the BEST-CLI trial. J Vasc Surg. 2025 Mar;81(3):720-729.e1. doi: 10.1016/j.jvs.2024.11.027. Epub 2024 Dec 3. |
| 39368637 | Derived | McGinigle KL, Doros G, Alabi O, Brooke BS, Vouyouka A, Hiramoto J, Charlton-Ouw K, Strong MB, Rosenfield K, Menard MT, Farber A, Giles KA. Female patients have fewer limb amputations compared to male patients in the BEST-CLI trial. J Vasc Surg. 2025 Feb;81(2):366-373.e1. doi: 10.1016/j.jvs.2024.09.031. Epub 2024 Oct 4. |
| 39332785 | Derived | Ochoa Chaar CI, Malas M, Doros G, Schermerhorn M, Conte MS, Alameddine D, Siracuse JJ, Yadavalli SD, Dake MD, Creager MA, Tan TW, Rosenfield K, Menard MT, Farber A, Hamdan A. The impact of diabetes mellitus on the outcomes of revascularization for chronic limb-threatening ischemia in the BEST-CLI trial. J Vasc Surg. 2025 Feb;81(2):376-385.e3. doi: 10.1016/j.jvs.2024.09.026. Epub 2024 Sep 25. |
| 39069016 | Derived | Menard MT, Farber A, Doros G, McGinigle KL, Chisci E, Clavijo LC, Kayssi A, Schneider PA, Hawkins BM, Dake MD, Hamza T, Strong MB, Rosenfield K, Conte MS. The impact of revascularization strategy on clinical failure, hemodynamic failure, and chronic limb-threatening ischemia symptoms in the BEST-CLI Trial. J Vasc Surg. 2024 Dec;80(6):1755-1765.e4. doi: 10.1016/j.jvs.2024.07.085. Epub 2024 Jul 26. |
| 38906430 | Derived | Alonso A, Kobzeva-Herzog AJ, Yahn C, Farber A, King EG, Hicks C, Eslami MH, Patel VI, Rybin D, Siracuse JJ. Higher stroke risk after carotid endarterectomy and transcarotid artery revascularization is associated with relative surgeon volume ratio. J Vasc Surg. 2024 Oct;80(4):1097-1103. doi: 10.1016/j.jvs.2024.05.035. Epub 2024 Jun 19. |
| 38626847 | Derived | Siracuse JJ, Menard MT, Rosenfield K, Conte MS, Powell R, Hamburg N, Doros G, Strong MB, Farber A. Characterization of cardiovascular serious adverse events after bypass or endovascular revascularization for limb-threatening ischemia in the BEST-CLI trial. J Vasc Surg. 2024 Sep;80(3):774-779. doi: 10.1016/j.jvs.2024.04.025. Epub 2024 Apr 16. |
| 37318428 | Derived | Siracuse JJ, Farber A, Menard MT, Conte MS, Kaufman JA, Jaff M, Kiang SC, Ochoa Chaar CI, Osborne N, Singh N, Tan TW, Guzman RJ, Strong MB, Hamza TH, Doros G, Rosenfield K. Perioperative complications following open or endovascular revascularization for chronic limb-threatening ischemia in the BEST-CLI Trial. J Vasc Surg. 2023 Oct;78(4):1012-1020.e2. doi: 10.1016/j.jvs.2023.05.040. Epub 2023 Jun 14. |
| 37040850 | Derived | Levin SR, Farber A, Kobzeva-Herzog A, King EG, Eslami MH, Garg K, Patel VI, Rockman CB, Rybin D, Siracuse JJ. Postoperative disability and one-year outcomes for patients suffering a stroke after carotid endarterectomy. J Vasc Surg. 2023 Aug;78(2):413-422.e1. doi: 10.1016/j.jvs.2023.04.002. Epub 2023 Apr 10. |
| 36435274 | Derived | Siracuse JJ, Rowe VL, Menard MT, Rosenfield K, Conte MS, Powell R, Clavijo LC, Giles KA, Hamza TH, Van Over M, Cziraky M, White CJ, Strong MB, Farber A. Relationship between WIfI stage and quality of life at revascularization in the BEST-CLI trial. J Vasc Surg. 2023 Apr;77(4):1099-1106.e4. doi: 10.1016/j.jvs.2022.11.050. Epub 2022 Nov 23. |
| 36342173 | Derived | 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. |
| 33825577 | Derived | 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. |
| 33314979 | Derived | 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. |
| 31010516 | Derived | 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. |
| 30683195 | Derived | 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. |
| 27402237 | Derived | 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. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 18, 2025 | Mar 10, 2025 |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D007871 | Leg Ulcer |
| D005734 | Gangrene |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D012816 | Signs and Symptoms |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009336 | Necrosis |
Not provided
Not provided