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Trial record 1 of 2 for:    BEST-CLI
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Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia (BEST-CLI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02060630
Recruitment Status : Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : February 26, 2020
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):
HealthCore-NERI

Tracking Information
First Submitted Date  ICMJE February 6, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE August 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Major Adverse Limb Event (MALE) [ Time Frame: At 48 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • Clinical status [ Time Frame: 30 days, 3, 6, 12, 18 and 24 months (30, 36, 42 and 48 months for subjects enrolled early in the trial) ]
    Clinical status will be determined by assessing amputation status, myocardial infarction status, stroke status, secondary intervention (major or minor) status in index leg, number of interventions (major and minor) per limb salvaged, hemodynamic failure status, and clinical failure status.
  • Quality of life [ Time Frame: 30 days, 3, 12, and 24 months (36 and 48 months for subjects enrolled early in the trial) ]
    Quality of life (QoL) assessments will be determined by using the VascuQoL, EuroQoL EQ-5D, SF-12 and (at selected sites) the six-minute walk test.
  • Cost-Effectiveness Status [ Time Frame: 30 days, 3, 6, 12, 18 and 24 months (30, 36, 42 and 48 months for subjects enrolled early in the trial) ]
    Treatment-associated costs (in- and out-patient) and incremental cost-effectiveness measured in dollars per quality-adjusted life years.
  • Major adverse limb event [ Time Frame: 30 days ]
    Composite of major adverse limb event (MALE)
  • Pain status [ Time Frame: 30 days, 3, 6, 12, 18 and 24 months (36 and 48 months for those enrolled early in the trial) ]
    Numeric rating scale (NRS) for pain
  • Perioperative death [ Time Frame: 30 days ]
    Composite of perioperative death (POD) (death within 30 days of index procedure)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
Official Title  ICMJE Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Brief 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 both treatment options.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Critical Limb Ischemia
Intervention  ICMJE
  • Procedure: Open surgical 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.
Study Arms  ICMJE
  • Available vein, open surg. revasc.
    Subjects with an available SSGSV cohort randomized to open surgical revascularization
    Intervention: Procedure: Open surgical revascularization
  • Available vein, endovasc. revasc.
    Subjects with an available SSGSV cohort randomized to endovascular revascularization
    Intervention: Device: Endovascular revascularization
  • Alternative conduit, open surg. revasc.
    Subjects with an alternative conduit cohort randomized to open surgical revascularization
    Intervention: Procedure: Open surgical revascularization
  • Alternative conduit, endovasc. revasc.
    Subjects with an alternative conduit cohort randomized to endovascular revascularization
    Intervention: Device: Endovascular revascularization
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 24, 2020)
1843
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
2100
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Finland,   Italy,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02060630
Other Study ID Numbers  ICMJE BEST-CLI Trial
1U01HL107407 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party HealthCore-NERI
Study Sponsor  ICMJE HealthCore-NERI
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Boston Medical Center
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
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.
PRS Account HealthCore-NERI
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP