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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02060630




Registration number
NCT02060630
Ethics application status
Date submitted
6/02/2014
Date registered
12/02/2014

Titles & IDs
Public title
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
Scientific title
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Secondary ID [1] 0 0
1U01HL107407
Secondary ID [2] 0 0
BEST-CLI Trial
Universal Trial Number (UTN)
Trial acronym
BEST-CLI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Limb Ischemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Endovascular revascularization

Other: Available vein, open surg. revasc. - Subjects with an available SSGSV cohort randomized to open surgical revascularization

Other: Available vein, endovasc. revasc. - Subjects with an available SSGSV cohort randomized to endovascular revascularization

Other: Alternative conduit, open surg. revasc. - Subjects with an alternative conduit cohort randomized to open surgical revascularization

Other: Alternative conduit, endovasc. revasc. - Subjects with an alternative conduit cohort randomized to endovascular revascularization


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)
Timepoint [1] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [1] 0 0
Clinical: Re-intervention and amputation-free survival (cohort 1)
Timepoint [1] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [2] 0 0
Clinical: Re-intervention and amputation-free survival (cohort 2)
Timepoint [2] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [3] 0 0
Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)
Timepoint [3] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [4] 0 0
Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2)
Timepoint [4] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [5] 0 0
Clinical: Amputation-free survival (cohort 1)
Timepoint [5] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [6] 0 0
Clinical: Amputation-free survival (cohort 2)
Timepoint [6] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [7] 0 0
Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1)
Timepoint [7] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [8] 0 0
Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2)
Timepoint [8] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [9] 0 0
Clinical: Freedom from Myocardial Infarction (cohort 1)
Timepoint [9] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [10] 0 0
Clinical: Freedom from Myocardial Infarction (cohort 2)
Timepoint [10] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [11] 0 0
Clinical: Freedom from Stroke (cohort 1)
Timepoint [11] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [12] 0 0
Clinical: Freedom from Stroke (cohort 2)
Timepoint [12] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [13] 0 0
Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1)
Timepoint [13] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [14] 0 0
Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2)
Timepoint [14] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [15] 0 0
Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1)
Timepoint [15] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [16] 0 0
Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2)
Timepoint [16] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [17] 0 0
Clinical: Freedom from hemodynamic failure (cohort 1)
Timepoint [17] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [18] 0 0
Clinical: Freedom from hemodynamic failure (cohort 2)
Timepoint [18] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [19] 0 0
Clinical: Freedom from clinical failure (cohort 1)
Timepoint [19] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [20] 0 0
Clinical: Freedom from clinical failure (cohort 2)
Timepoint [20] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [21] 0 0
Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1)
Timepoint [21] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [22] 0 0
Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2)
Timepoint [22] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [23] 0 0
Clinical: Freedom from all-cause mortality (cohort 1)
Timepoint [23] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [24] 0 0
Clinical: Freedom from all-cause mortality (cohort 2)
Timepoint [24] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [25] 0 0
Functional: Quality of Life assessment using VasuQoL (cohort 1)
Timepoint [25] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [26] 0 0
Functional: Quality of Life assessment using VasuQoL (cohort 2)
Timepoint [26] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [27] 0 0
Functional: Quality of Life assessment using EuroQoL (cohort 1)
Timepoint [27] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [28] 0 0
Functional: Quality of Life assessment using EuroQoL (cohort 2)
Timepoint [28] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [29] 0 0
Functional: Function assessment using SF-12, PCS (cohort 1)
Timepoint [29] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [30] 0 0
Functional: Function assessment using SF-12, PCS (cohort 2)
Timepoint [30] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [31] 0 0
Functional: Function assessment using SF-12, MCS (cohort 1)
Timepoint [31] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [32] 0 0
Functional: Function assessment using SF-12, MCS (cohort 2)
Timepoint [32] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [33] 0 0
Functional: Function assessment using SF-12, SF-6D R2 (cohort 1)
Timepoint [33] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [34] 0 0
Functional: Function assessment using SF-12, SF-6D R2(cohort 2)
Timepoint [34] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [35] 0 0
Functional: Numerical rating scale for Pain, Pain Now (cohort 1)
Timepoint [35] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [36] 0 0
Functional: Numerical rating scale for Pain, Pain Now (cohort 2)
Timepoint [36] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [37] 0 0
Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1)
Timepoint [37] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [38] 0 0
Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2)
Timepoint [38] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [39] 0 0
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1)
Timepoint [39] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [40] 0 0
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2)
Timepoint [40] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [41] 0 0
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1)
Timepoint [41] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [42] 0 0
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2)
Timepoint [42] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [43] 0 0
Function: Six-minute walk test (cohort 1)
Timepoint [43] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcome [44] 0 0
Function: Six-minute walk test (cohort 2)
Timepoint [44] 0 0
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2022
Sample size
Target
Accrual to date
Final
1843
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
New Hampshire
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New Mexico
Country [25] 0 0
United States of America
State/province [25] 0 0
New York
Country [26] 0 0
United States of America
State/province [26] 0 0
North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Ohio
Country [28] 0 0
United States of America
State/province [28] 0 0
Oklahoma
Country [29] 0 0
United States of America
State/province [29] 0 0
Oregon
Country [30] 0 0
United States of America
State/province [30] 0 0
Pennsylvania
Country [31] 0 0
United States of America
State/province [31] 0 0
Rhode Island
Country [32] 0 0
United States of America
State/province [32] 0 0
South Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
South Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Tennessee
Country [35] 0 0
United States of America
State/province [35] 0 0
Texas
Country [36] 0 0
United States of America
State/province [36] 0 0
Utah
Country [37] 0 0
United States of America
State/province [37] 0 0
Vermont
Country [38] 0 0
United States of America
State/province [38] 0 0
Virginia
Country [39] 0 0
United States of America
State/province [39] 0 0
Washington
Country [40] 0 0
United States of America
State/province [40] 0 0
West Virginia
Country [41] 0 0
United States of America
State/province [41] 0 0
Wisconsin
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Manitoba
Country [44] 0 0
Canada
State/province [44] 0 0
Nova Scotia
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
Canada
State/province [47] 0 0
Saskatchewan
Country [48] 0 0
Finland
State/province [48] 0 0
Helsinki
Country [49] 0 0
Italy
State/province [49] 0 0
Florence
Country [50] 0 0
New Zealand
State/province [50] 0 0
Auckland
Country [51] 0 0
New Zealand
State/province [51] 0 0
Waikato
Country [52] 0 0
New Zealand
State/province [52] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Carelon Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Brigham and Women's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Massachusetts General Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Boston Medical Center
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/industry
Name [5] 0 0
Abbott
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Commercial sector/industry
Name [6] 0 0
Bard Ltd
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/industry
Name [7] 0 0
Boston Scientific Corporation
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Commercial sector/industry
Name [8] 0 0
Cordis Corporation
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Commercial sector/industry
Name [9] 0 0
Abbott Medical Devices
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Canadian Society for Vascular Surgery
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Eastern Vascular Society
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Commercial sector/industry
Name [12] 0 0
W.L.Gore & Associates
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Midwest Vascular Society
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
New England Society for Vascular Surgery
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Society for Clinical Vascular Surgery
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Society for Interventional Radiology
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
Southern Vascular Society
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
Society for Vascular Medicine
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
Society for Vascular Surgery
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Other
Name [20] 0 0
Vascular and Endovascular Surgery Society
Address [20] 0 0
Country [20] 0 0
Other collaborator category [21] 0 0
Other
Name [21] 0 0
Vascular Interventional Advances
Address [21] 0 0
Country [21] 0 0
Other collaborator category [22] 0 0
Other
Name [22] 0 0
Western Vascular Society
Address [22] 0 0
Country [22] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew Menard, MD
Address 0 0
Brigham and Women's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02060630