Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

HealthCore-NERI

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Stanford Investigator(s):

Intervention(s):

  • Procedure: Open surgical revascularization
  • Device: Endovascular revascularization

Phase:

N/A

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Venita Chandra, MD
Recruiting