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Completed

NCT Number: NCT02060630

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

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.

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Gangrene Intermittent Claudication Ischemia Leg Ulcer Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open surgical revascularization

Procedure

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.

Primary outcomes

  1. 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 frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    • 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 outcomes

  1. Clinical: Re-intervention and amputation-free survival (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    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

  2. Clinical: Re-intervention and amputation-free survival (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    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

  3. Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    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

  4. Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    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

  5. Clinical: Amputation-free survival (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available

  6. Clinical: Amputation-free survival (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV

  7. Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to death within 30 days of index procedure in subjects with SSGSV available

  8. Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to death within 30 days of index procedure in subjects without available SSGSV

  9. Clinical: Freedom from Myocardial Infarction (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to myocardial infarction (MI) in subjects with SSGSV available

  10. Clinical: Freedom from Myocardial Infarction (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to myocardial infarction (MI) in subjects without available SSGSV

  11. Clinical: Freedom from Stroke (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to stroke in subjects with SSGSV available

  12. Clinical: Freedom from Stroke (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to stroke in subjects without available SSGSV

  13. Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to re-intervention (major and minor) in index leg in subjects with SSGSV available

  14. Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to re-intervention (major and minor) in index leg in subjects without available SSGSV

  15. Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Number of re-interventions (major and minor) in per limb salvaged in subjects with SSGSV available

  16. Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Number of re-interventions (major and minor) in per limb salvaged in subjects without available SSGSV

  17. Clinical: Freedom from hemodynamic failure (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to hemodynamic failure in subjects with SSGSV available

  18. Clinical: Freedom from hemodynamic failure (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to hemodynamic failure in subjects without available SSGSV

  19. Clinical: Freedom from clinical failure (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects with SSGSV available

  20. Clinical: Freedom from clinical failure (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects without available SSGSV

  21. Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to resolution of presenting CLI symptoms in the index limb in subjects with SSGSV available

  22. Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to resolution of presenting CLI symptoms in the index limb in subjects without available SSGSV

  23. Clinical: Freedom from all-cause mortality (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to all-cause mortality in subjects with SSGSV available

  24. Clinical: Freedom from all-cause mortality (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Time to all-cause mortality in subjects without available SSGSV

  25. Functional: Quality of Life assessment using VasuQoL (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    VasuQOL measurements in subjects with SSGSV available

  26. Functional: Quality of Life assessment using VasuQoL (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    VasuQOL measurements in subjects without available SSGSV

  27. Functional: Quality of Life assessment using EuroQoL (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    EuroQOL measurements in subjects with SSGSV available

  28. Functional: Quality of Life assessment using EuroQoL (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    EuroQOL measurements in subjects without available SSGSV

  29. Functional: Function assessment using SF-12, PCS (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Physical Component Summary (PCS) scores in subjects with SSGSV available

  30. Functional: Function assessment using SF-12, PCS (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Physical Component Summary (PCS) scores in subjects without available SSGSV

  31. Functional: Function assessment using SF-12, MCS (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Mental Component Summary (MCS) scores in subjects with SSGSV available

  32. Functional: Function assessment using SF-12, MCS (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Mental Component Summary (MCS) scores in subjects without available SSGSV

  33. Functional: Function assessment using SF-12, SF-6D R2 (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Utility Index (SF-6D R2) scores in subjects with SSGSV available

  34. Functional: Function assessment using SF-12, SF-6D R2(cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Utility Index (SF-6D R2) scores in subjects without available SSGSV

  35. Functional: Numerical rating scale for Pain, Pain Now (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Scores for Pain Now in subjects with SSGSV available

  36. Functional: Numerical rating scale for Pain, Pain Now (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Scores for Pain Now in subjects without available SSGSV

  37. Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Scores for Usual level of Pain during the last week in subjects with SSGSV available

  38. Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Scores for Usual level of Pain during the last week in subjects without available SSGSV

  39. Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Scores for Best level of Pain during the last week in subjects with SSGSV available

  40. Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Scores for Best level of Pain during the last week in subjects without available SSGSV

  41. Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Scores for Worst level of Pain during the last week in subjects with SSGSV available

  42. Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    Scores for Worst level of Pain during the last week in subjects without available SSGSV

  43. Function: Six-minute walk test (cohort 1)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    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

  44. Function: Six-minute walk test (cohort 2)

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

    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

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Collaborators

  • Abbott
  • Abbott Medical Devices
  • Bard Ltd
  • Boston Medical Center
  • Boston Scientific Corporation
  • Brigham and Women's Hospital
  • Canadian Society for Vascular Surgery
  • Cordis US Corp.
  • Eastern Vascular Society
  • Massachusetts General Hospital
  • Midwest Vascular Society
  • National Heart, Lung, and Blood Institute (NHLBI)
  • New England Society for Vascular Surgery
  • Society for Clinical Vascular Surgery
  • Society for Interventional Radiology
  • Society for Vascular Medicine
  • Society for Vascular Surgery
  • Southern Vascular Society
  • Vascular Interventional Advances
  • Vascular and Endovascular Surgery Society
  • W.L.Gore & Associates
  • Western Vascular Society

Registry information

Official study title

Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

Acronym: BEST-CLI

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2014
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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