Monday, September 8, 2025 9/8/2025

BEST-CLI Trial-DCC

Award Number: U01HL107407
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2013
PERIOD OF PERFORMANCE END DATE: 09/30/2022

Group Awards By:

View Award Description

BEST-CLI Trial-DCC - DESCRIPTION (provided by applicant): This resubmission is comprised of three applications (Clinical and Data Coordinating Centers (CCC, DCC) and Cost-Effectiveness Analysis Core). We propose to conduct a large (N=2100) simple, superiority trial in the US and Canada - BEST - comparing best open surgery to best endovascular revascularization to prevent mortality, limb-amputation or further revascularization in a target limb with critical limb ischemia (CLI), meeting the current mandate for assessing comparative effectiveness. Trial leadership is comprised of a closely integrated and highly experienced group of investigators based at a CCC (Brigham and Women's Hospital, BWH , Boston University Medical Center, BUMC, and Massachusetts Hospital, MGH, Boston, MA), a DCC (New England Research Institutes, Inc., Watertown, MA) and an Executive Committee of experts in the field. The Health Economics Group at BWH will work closely with the DCC to address assessment of quality of life and cost-effectiveness (C-E). The trial will be conducted at approximately 120 sites in the U.S. and Canada, builds upon prior feasibility data and endeavors to address limitations of current research in this area. Peripheral artery disease prevalence is 15-20% over 70 years, with higher rates in smokers and diabetics. In the subset with CLI, 40% require limb amputation and annual mortality exceeds 20%. With the advent of endovascular techniques for revascularization, we demonstrate from our completed surveys that there is current equipoise among practitioners with respect to best therapy in the majority of CLI cases. The BEST trial will provide, for the first time, urgently needed clinical guidance for CLI management in the context of C-E by using: a pragmatic design, including a range of established techniques; a novel primary endpoint - MALE (major adverse limb event including limb amputation or major re-intervention, bypass graft/graft revision or thrombectomy/thrombolysis) - free survival; multi-disciplinary recruitment of vascular surgeons and interventional cardiologists and radiologists; and an innovative, cost-efficient C-E approach. Additional endpoints include other clinical event rates, functional status and QOL and C-E, all using standard definitions and instruments. 140 eligible centers in North America will be approached to ensure 120 are initiated and 80 sites each recruit 1 subject/month over 27 months accrual. Trial duration is 4.25 yrs - 2.25 yrs accrual and 2.0 yrs minimum follow-up. Two cohorts will be studied: All-Vein (N=1620) and Prosthetic Conduit (N=480). Within each cohort, the trial is stratified on 2 factors (4 strata): tissue loss vs. isolated rest pain and infrainguinl with/without significant infrapopliteal occlusive disease. In the All-Vein cohort, BEST has 85% power to detect an EVT vs. OPEN hazard ratio of 1.25 in the primary endpoint (MALE-free survival) with crossover rates accounted for, as well as 2% loss to follow-up. In the Prosthetic Conduit cohort, there is 80% power to detect a hazard ratio of 0.70 for the primary endpoint. This resubmission fully addresses all prior reviewer concerns, to successfully and efficiently execute a trial that will provide important information for the CLI community.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = -$1,491 )
2023	2019	NEW ENGLAND RESEARCH INSTITUTES INC	220 VIRGINIA AVE	INDIANAPOLIS	IN	46204	MARION	USA	Cardiovascular Diseases Research	000	5	9/27/2023	NON-COMPETING CONTINUATION	-$1,491
														Subtotal = -$1,491

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	000	5	3/9/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	000	5	2/11/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	001	5	7/28/2020	NON-COMPETING CONTINUATION	$0
2020	2019	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	000	5	4/4/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $4,787,572 )
2019	2019	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	000	5	5/18/2019	NON-COMPETING CONTINUATION	$4,787,572
														Subtotal = $4,787,572

Issue Date FY: 2018 ( Subtotal = $3,671,871 )
2018	2018	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	000	4	4/19/2018	NON-COMPETING CONTINUATION	$3,671,871
														Subtotal = $3,671,871

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	001	3	5/19/2017	EXTENSION WITH OR WITHOUT FUNDS	$0
2017	2016	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	000	3	4/13/2017	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $6,194,631 )
2016	2016	NEW ENGLAND RESEARCH INSTITUTE, INC	9 GALEN STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	001	3	4/4/2016	EXTENSION WITH OR WITHOUT FUNDS	$6,194,631
2016	2015	NEW ENGLAND RESEARCH INSTITUTE, INC	9 GALEN STREET	WATERTOWN	MA	02172		USA	Cardiovascular Diseases Research	000	2	11/20/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $6,194,631

Issue Date FY: 2015 ( Subtotal = $4,085,127 )
2015	2015	NEW ENGLAND RESEARCH INSTITUTE, INC	9 GALEN STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	000	2	1/8/2015	NON-COMPETING CONTINUATION	$4,085,127
														Subtotal = $4,085,127

Issue Date FY: 2014 ( Subtotal = $0 )
2014	2013	NEW ENGLAND RESEARCH INSTITUTE, INC	9 GALEN STREET	WATERTOWN	MA	02172		USA	Cardiovascular Diseases Research	000	1	6/26/2014	NEW	$0
														Subtotal = $0

Issue Date FY: 2013 ( Subtotal = $1,228,887 )
2013	2013	NEW ENGLAND RESEARCH INSTITUTE, INC	9 GALEN STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Cardiovascular Diseases Research	000	1	9/17/2013	NEW	$1,228,887
														Subtotal = $1,228,887

Grand Total All Awards = $19,966,597

Top

All Categories

About

Search

Reports

Data Submission

Award Information

BEST-CLI Trial-DCC

Award Number: U01HL107407

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/17/2013

PERIOD OF PERFORMANCE END DATE: 09/30/2022

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer