HVP BEST-CLI-Best Endovascular Versus 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.

Key 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.

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Heart and Vascular
Peripheral Artery Disease, Atherosclerosis, Endovascular
Ethan Korngold MD
NERI (New England Research Institutes)
Ellen Muir
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center
  • TOC Gateway - Heart Clinic