Principal Investigator: Benjamin Brooke
Keywords: peripheral arterial disease , critical limb ischemia , endovascular , angiography , surgery , vein mapping , revascularization , bypass , vascular surgery Department: Vascular Surgery
IRB Number: 00072080 Co Investigator: Benjamin Brooke
Specialty: Vascular Surgery
Sub Specialties:
Recruitment Status: Active, not recruiting

Contact Information

Julie  Beckstrom
julie.beckstrom@hsc.utah.edu
801-587-1450

Simple 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 either treatment option.

Inclusion Criteria

There are no differences in the inclusion and exclusion criteria between VA and University populations.

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 either open or endovascular infrainguinal revascularization as judged by the treating investigators (see MOO for guidelines on decision-making approach).

- Adequate aortoiliac inflow (see protocol section 4.1 for definition)

- 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.

- Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Exclusion Criteria

There are no differences in the inclusion and exclusion criteria between VA and University populations.

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

- Acute 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 the 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:

a.- Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;

b.- Infrainguinal bypass with either venous or prosthetic conduit;

c.- Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral 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) and which would preclude patient participation in angiographic procedures.

- Pregnancy or lactation.

- Administration of an investigational drug for PAOD 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

Participant Reimbursement

$270.00 If you finish the whole studyYou will be given a $30 gift card as a token of thanks for helping with our research at each face-to-face visit for the screening period and for visits after your procedure during months 1,3, 6,12,18, 24, 36 and 48. You will receive this gift card from the University of Utah clinic after each of your scheduled and completed study clinic visits.