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Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia (BEST-CLI)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by New England Research Institutes
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Boston Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT02060630
First received: February 6, 2014
Last updated: June 20, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Critical Limb Ischemia Procedure: Open surgical revascularization Device: Endovascular revascularization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

Secondary Outcome Measures:
  • Time to re-intervention of the index leg, amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Time to re-intervention of the index leg, amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Number of re-interventions in the index leg in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Number of re-interventions in the index leg in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Time to all-cause mortality in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Time to all-cause mortality in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Change in VascuQoL score in subjects with SSGSV available [ Time Frame: 30 days post-procedure, 3 months, 12 months, 24 months, 36 months, and 48 months ]
  • Change in VascuQoL score in subjects without available SSGSV [ Time Frame: 30 days post-procedure, 3 months, 12 months, 24 months, 36 months, and 48 months ]
  • Change in EuroQoL EQ-5D score in subjects with SSGSV available [ Time Frame: 30 days post-procedure, 3 months, 12 months, 24 months, 36 months, and 48 months ]
  • Change in EuroQoL EQ-5D score in subjects without available SSGSV [ Time Frame: 30 days post-procedure, 3 months, 12 months, 24 months, 36 months, and 48 months ]
  • Treatment associated costs in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Treatment associated costs in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Major adverse cardiovascular events in subjects with SSGSV available [ Time Frame: 30 days post-procedure ]
  • Major adverse cardiovascular events in subjects without available SSGSV [ Time Frame: 30 days post-procedure ]
  • Proportion of subjects with at least one peri-operative complication in subjects with SSGSV available [ Time Frame: 30 days post-procedure ]
  • Proportion of subjects with at least one peri-operative complication in subjects without available SSGSV [ Time Frame: 30 days post-procedure ]

Estimated Enrollment: 2100
Study Start Date: August 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Available vein, open surg. revasc.
Subjects with an available SSGSV cohort randomized to open surgical revascularization
Procedure: Open surgical revascularization
Available vein, endovasc. revasc.
Subjects with an available SSGSV cohort randomized to endovascular revascularization
Device: Endovascular revascularization
A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.
Alternative conduit, open surg. revasc.
Subjects with an alternative conduit cohort randomized to open surgical revascularization
Procedure: Open surgical revascularization
Alternative conduit, endovasc. revasc.
Subjects with an alternative conduit cohort randomized to endovascular revascularization
Device: Endovascular revascularization
A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060630

Contacts
Contact: Flora S Siami, MPH 617-972-3317 ssiami@neriscience.com

  Show 156 Study Locations
Sponsors and Collaborators
New England Research Institutes
Brigham and Women's Hospital
Massachusetts General Hospital
Boston Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Matthew Menard, MD Brigham and Women's Hospital
Principal Investigator: Alik Farber, MD Boston University
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
Principal Investigator: Flora S Siami, MPH New England Research Institutes, Inc.
Principal Investigator: Susan Assmann, PhD New England Research Institutes, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT02060630     History of Changes
Other Study ID Numbers: BEST-CLI Trial
1U01HL107407 ( U.S. NIH Grant/Contract )
Study First Received: February 6, 2014
Last Updated: June 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by New England Research Institutes:
Surgical revascularization
Endovascular revascularization
Amputation
Peripheral artery disease
Critical limb ischemia
claudication
leg pain
leg ulcer
gangrene

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2017