Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
Status: | Recruiting |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2018 |
Start Date: | August 2014 |
End Date: | December 2019 |
Contact: | Flora S Siami, MPH |
Email: | ssiami@neriscience.com |
Phone: | 617-972-3317 |
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.
available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible
for both treatment options.
Male and female subjects aged 18 years or older will be randomized to receive either open
surgical treatment or endovascular treatment. They will be followed for at least 2 years and
up to 4 years and 2 months after treatment to primarily assess survival and major adverse
limb events in the index or treated limb, and secondarily, to determine clinical and cost
effectiveness outcomes after treatment. These outcomes (survival-free of major limb events
and clinical, functional and cost effectiveness) will be compared within two cohorts of
subjects: those with an available single-segment great saphenous vein, and those with an
alternative conduit. The null hypotheses for both cohorts is that there will be no difference
in MALE-free survival between best endovascular therapy and best surgical therapy.
surgical treatment or endovascular treatment. They will be followed for at least 2 years and
up to 4 years and 2 months after treatment to primarily assess survival and major adverse
limb events in the index or treated limb, and secondarily, to determine clinical and cost
effectiveness outcomes after treatment. These outcomes (survival-free of major limb events
and clinical, functional and cost effectiveness) will be compared within two cohorts of
subjects: those with an available single-segment great saphenous vein, and those with an
alternative conduit. The null hypotheses for both cohorts is that there will be no difference
in MALE-free survival between best endovascular therapy and best surgical therapy.
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.
We found this trial at
151
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University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Kansas City, Missouri 64116
Principal Investigator: Scott Kujath, MD
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Kingsport, Tennessee 37660
Principal Investigator: Chris Metzger, MD
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Knoxville, Tennessee 37920
Principal Investigator: Laura Findeiss, MD
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1900 South Avenue
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
Principal Investigator: Ezana Azene, MD
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La Jolla, California 92037
Principal Investigator: John Lane, MD
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Little Rock, Arkansas 72205
Principal Investigator: Matthew Smeds, MD
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11234 Anderson St
Loma Linda, California 92354
Loma Linda, California 92354
(909) 558-4000
![Loma Linda University Medical Center](/wp-content/uploads/logos/loma-linda-university-medical-center.png)
Principal Investigator: Ahmed Abou-Zamzam, MD
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Loma Linda, California 92357
Principal Investigator: Christian Bianchi, MD
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Long Beach, California 90822
Principal Investigator: Ian Gordon, MD
Phone: 562-618-1656
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Los Angeles, California 90095
Principal Investigator: Peter Lawrence, MD
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4733 Sunset Blvd
Los Angeles, California 90027
Los Angeles, California 90027
(800) 954-8000
![Kaiser Permanente Los Angeles Medical Center](/wp-content/uploads/logos/kaiser-permanente-los-angeles-medical-center.png)
Principal Investigator: Kaushal Patel, MD
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
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Madison, Wisconsin 53706
(608) 263-2400
![University of Wisconsin-Madison](/wp-content/uploads/logos/university-of-wisconsin-madison.jpg)
Principal Investigator: John Hoch, MD
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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8900 N Kendall Dr
Miami, Florida 33176
Miami, Florida 33176
(786) 596-1960
![Baptist Hospital of Miami](/wp-content/uploads/logos/baptist-hospital-of-miami.jpg)
Principal Investigator: James Benenati, MD
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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4300 Alton Road
Miami Springs, Florida 33140
Miami Springs, Florida 33140
Principal Investigator: Robert Beasley, MD
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
Milwaukee, Wisconsin
(414) 955-8296
![Medical College of Wisconsin](/wp-content/uploads/logos/medical-college-of-wisconsin.jpg)
Principal Investigator: Parag Patel, MD
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Minneapolis, Minnesota 55407
Principal Investigator: Jason Alexander, MD
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20 York St, N20 York St,
New Haven, Connecticut 06520
New Haven, Connecticut 06520
(203) 688-4242
![Yale-New Haven Hospital](/wp-content/uploads/logos/yale-new-haven-hospital.jpg)
Principal Investigator: Carlos Mena-Hurtado, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
504-842-3000
![Ochsner Medical Center](/wp-content/uploads/logos/ochsner-medical-center.jpg)
Principal Investigator: J. Stephen Jenkins, MD
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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630 W 168th St
New York, New York
New York, New York
212-305-2862
![Columbia University Medical Center](/wp-content/uploads/logos/columbia-university-medical-center.jpg)
Principal Investigator: Danielle Bajakian, MD
Phone: 212-305-8665
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
![University of Oklahoma Health Sciences Center](/wp-content/uploads/logos/university-of-oklahoma-health-sciences-center.png)
Principal Investigator: Beau Hawkins, MD
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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