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Active Clinical Trials

BEST-CLI

Active NCT: 02060630
Allegheny General Hospital
Allegheny General Hospital

Forbes Hospital
Forbes Hospital

Sponsor: 
New England Research Institutes
Contact: 

For more information, please contact Sheila Bernardini at 412-359-3281 or Sheila.Bernardini@ahn.org.

BEST-CLI: Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia

Purpose: 

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.

Inclusion criteria (all must be met for eligibility)

  1. Male or female, age 35 years or older.
  2. Atherosclerotic, infrainguinal PAD (occlusive disease of the arteries below the inguinal ligament caused by atherosclerosis).
  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 (see MOO for guidelines on decision-making).
  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 (none can be met for eligibility)

  1. Disease limited to the femoropopliteal segment with TASC II A pattern.
  2. Presence of severe (> 50% stenosis) ipsilateral common femoral artery disease
  3. Presence of a popliteal aneurysm (> 2 cm) in the index limb.
  4. Life expectancy of less than 2 years due to reasons other than PAD.
  5. Considered to be at excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team following pre-operative cardiac risk assessment).
  6. Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
  7. Known anti-phospholipid antibodies or lupus anticoagulant; or known Protein C deficiency, Protein S deficiency or Antithrombin III deficiency if treated or advised to be treated with long-term anticoagulation on the basis of this diagnosis.
  8. Non-atherosclerotic occlusive disease (e.g. embolic disease, trauma, vasculitis, Buerger’s disease) or acute limb-threatening ischemia (defined as tissue loss or ischemic rest pain of less than 14 days duration).
  9. Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis.
  10. Any of the following procedures performed on the index limb within 6 months prior to enrollment:
    1. Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
    2. Common, superficial, or deep femoral endarterectomy;
    3. Infrainguinal bypass with either venous or prosthetic conduit;
    4. Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass)
  11. Current immune-suppressive medication, 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. Known allergy to stainless steel or nitinol.
  14. Pregnancy or lactation.
  15. Administration of an investigational drug for PAD within 30 days of randomization.
  16. Participation in a clinical trial (except observational studies) within the previous 30 days.
  17. Prior enrollment or randomization into BEST-CLI.