Study of best available surgical treatment/best available endovascular treatment in adults with CLI, eligible for both treatments

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"Is angiplasty (endovascular) or bypass graft (open surgery) best for critical limb ischemia (CLI)?"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
critical limb ischema, peripheral artery disease
Type:
Procedure study
Investigator:
Description
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.
CLI is usually treated by operations or procedures that increase blood flow to the leg and foot, in order to relieve these symptoms, heal the ulcers, and preserve the limb. There are two different ways to increase the blood flow in CLI. One is with open surgery, which creates a bypass around the blockage. The other is with endovascular treatment (often called angioplasty), a minimally invasive procedure that opens the blocked arteries directly. Angioplasty is performed with balloons and other tools that clear plaque, and sometimes permanent implantation of small, mesh-like metal tubes called “stents”. Both types of treatment – open surgery and angioplasty - are considered reasonable and appropriate for patients with CLI like you. The study doctors have determined, on the basis of your medical history and tests, that you are eligible for both treatments
This study requires
History and Physical
Vein mapping
X-ray imaging test
Hemodynamic assessment
Blood tests
Questionnaires
6-min walk test
Procedure visit: Either angioplasty(endovacular) or bypass graft (open surgery)
Follow up visits
Who can participate?
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.
Resources
Schedule
Study duration and period
Up to 4.5 years, 8 visits, 3 phone calls
Recruitment period
From Oct. 13, 2014
Location
UC Davis Vascular Center
4860 Y Street
Suite 2100
Sacramento, CA 95817
Contact
Lynda Painting
Research Topic
Conditions:
  • Critical Limb Ischemia

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