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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Official Title

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

Details

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.

Keywords

Critical Limb Ischemia Surgical revascularization Endovascular revascularization Amputation Peripheral artery disease claudication leg pain leg ulcer gangrene

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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:
  8. Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
  9. Infrainguinal bypass with either venous or prosthetic conduit
  10. Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral,thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment
  11. Current chemotherapy or radiation therapy.
  12. 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.
  13. Pregnancy or lactation.
  14. Administration of an investigational drug for PAD within 30 days of randomization.
  15. Participation in a clinical trial (except observational studies) within the previous 30 days.
  16. Prior enrollment or randomization into BEST-CLI.

Locations

  • Kaiser Permanente North California accepting new patients
    San Francisco, California, United States
  • VA Palo Alto Health Care accepting new patients
    Palo Alto, California, 94304, United States
  • Stanford Hospital accepting new patients
    Standford, California, 94305, United States
  • University of California Davis Medical Center accepting new patients
    Sacramento, California, 95817, United States
  • Kaiser Permanente Los Angeles Medical Center accepting new patients
    Los Angeles, California, 90027, United States
  • Cedars-Sinai Heart Institute accepting new patients
    Los Angeles, California, 90048, United States
  • VA Greater Los Angeles accepting new patients
    Los Angeles, California, 90073, United States
  • Keck Medical Center of USC accepting new patients
    Los Angeles, California, 90089, United States
  • UCLA-Gonda Vascular Surgery accepting new patients
    Los Angeles, California, 90095, United States
  • Harbor - UCLA Medical Center accepting new patients
    Torrance, California, 90509, United States
  • St. Joseph Hospital withdrawn
    Orange, California, 92865, United States
  • Loma Linda University Medical Center accepting new patients
    Loma Linda, California, 92354, United States
  • Loma Linda VA Medical Center accepting new patients
    Loma Linda, California, 92357, United States
  • University of California - Irvine accepting new patients
    Irvine, California, 92697, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
New England Research Institutes
ID
NCT02060630
Lead Scientist
Jade Hiramoto
Study Type
Interventional
Last Updated
January 1, 2017
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