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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

Award Number: U01NS080168
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2014
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) - PROJECT SUMMARY The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2, U01 NS080168) consists of two parallel randomized trials in patients with asymptomatic high- grade carotid artery stenosis. One trial compares Intensive Medical Management (IMM) plus carotid endarterectomy to IMM alone, and the other compares IMM plus carotid artery stenting to IMM alone. The trial is registered with clinicaltrials.gov (NCT02089217). Monitoring plays a crucial role in ensuring the protection of subjects and the validity of the science. Additionally, monitoring is required for the CREST-2 trial by the FDA and NINDS. As of July 31, 2024, CREST- 2 has enrolled a total of 2,486 patients: 1,241 in the endarterectomy trial and 1,245 in the stenting trial. Patients have been enrolled across 183 sites (171 US and 12 international). To be cost-effective in monitoring these clinical sites, the CREST-2 Clinical Coordinating Center has taken on the responsibility of hiring and managing the monitor rather than outsourcing the responsibility to a Clinical Research Organization. During the course of the trial, monitoring has adapted for various reasons most notably the COVID-19 pandemic. Most monitoring visits were conducted on-site prior to the COVID-19 pandemic, remote monitoring and quality control checks were implemented during the COVID-19 pandemic, and a combination of remote and on-site monitoring have been used since March 2023. The approval of a previous administrative supplement request provided funding to partially fund and support travel for our current Monitor. Through that approval, we were able to resume site-level source document verification in the CREST-2 trial. From March 2023 to July 2024, a total of 41 monitoring visits have been conducted, including 25 onsite and 16 remote visits. Furthermore, we have collaborated with our Statistical and Data Coordinating Center to develop forensic and risk-based monitoring approaches, developed and deployed a survey on remote vs. in person monitoring preferences to all CREST-2 sites, refined our site closeout monitoring process, developed a risk-based monitoring prioritization system, built reports and dashboards in Smartsheet to track monitoring efforts, and increased the frequency of data quality meetings to enhance data quality and completeness as we near the end of the trial. With approximately two years remaining of grant activities, we request additional funding through an Administrative Supplement to continue monitoring efforts. The goals of this supplement are to continue onsite and remote monitoring, close out CREST-2 sites once final follow-up visits occur, and help ensure a complete and verifiable dataset.


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: 2025 ( Subtotal = $459,324 )
2025	2025	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	12	9/22/2025	SUPPLEMENT FOR EXPANSION	$156,497
2025	2025	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	12	8/26/2025	NON-COMPETING CONTINUATION	$302,827
2025	2024	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	11	4/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $459,324

Issue Date FY: 2024 ( Subtotal = $1,284,994 )
2024	2024	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	11	8/22/2024	NON-COMPETING CONTINUATION	$1,284,994
2024	2024	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	11	9/19/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,284,994

Issue Date FY: 2023 ( Subtotal = $2,928,081 )
2023	2023	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	10	9/20/2023	NON-COMPETING CONTINUATION	$2,774,711
2023	2023	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	10	9/21/2023	SUPPLEMENT FOR EXPANSION	$153,370
2023	2022	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	9	5/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,928,081

Issue Date FY: 2022 ( Subtotal = $4,512,527 )
2022	2022	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	9	8/24/2022	NON-COMPETING CONTINUATION	$4,512,527
2022	2021	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	8	2/18/2022	COMPETING CONTINUATION	$1
2022	2020	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	2/18/2022	NON-COMPETING CONTINUATION	-$1
														Subtotal = $4,512,527

Issue Date FY: 2021 ( Subtotal = $6,951,418 )
2021	2021	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	8	8/27/2021	COMPETING CONTINUATION	$6,951,418
2021	2020	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	7	8/26/2021	NON-COMPETING CONTINUATION	$0
2021	2020	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	4/23/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $6,951,418

Issue Date FY: 2020 ( Subtotal = $4,069,399 )
2020	2020	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	7	5/1/2020	NON-COMPETING CONTINUATION	$0
2020	2020	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	4/3/2020	NON-COMPETING CONTINUATION	$4,069,399
2020	2020	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	7	5/5/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $4,069,399

Issue Date FY: 2019 ( Subtotal = $2,910,600 )
2019	2019	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	004	6	4/18/2019	NON-COMPETING CONTINUATION	$0
2019	2019	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	005	6	6/14/2019	NON-COMPETING CONTINUATION	$0
2019	2019	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	6	3/29/2019	NON-COMPETING CONTINUATION	$2,910,600
2019	2018	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	5	3/27/2019	NON-COMPETING CONTINUATION	$0
2019	2017	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	3/27/2019	NON-COMPETING CONTINUATION	$0
2019	2016	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	3/27/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,910,600

Issue Date FY: 2018 ( Subtotal = $6,131,342 )
2018	2018	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	3/7/2018	NON-COMPETING CONTINUATION	$6,131,342
														Subtotal = $6,131,342

Issue Date FY: 2017 ( Subtotal = $13,280,995 )
2017	2017	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	4	9/22/2017	NON-COMPETING CONTINUATION	$6,131,342
2017	2017	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	3/10/2017	NON-COMPETING CONTINUATION	$6,434,687
2017	2017	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	6/5/2017	NON-COMPETING CONTINUATION	$714,966
														Subtotal = $13,280,995

Issue Date FY: 2016 ( Subtotal = $6,297,501 )
2016	2016	MAYO CLINIC JACKSONVILLE	4500 SAN PABLO ROAD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	3/2/2016	NON-COMPETING CONTINUATION	$6,297,501
														Subtotal = $6,297,501

Issue Date FY: 2015 ( Subtotal = $4,678,363 )
2015	2015	MAYO CLINIC JACKSONVILLE	4500 SAN PABLO ROAD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	3/3/2015	NON-COMPETING CONTINUATION	$4,678,363
														Subtotal = $4,678,363

Issue Date FY: 2014 ( Subtotal = $2,640,107 )
2014	2014	MAYO CLINIC JACKSONVILLE	4500 SAN PABLO ROAD	JACKSONVILLE	FL	32224	DUVAL	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	3/11/2014	NEW	$2,640,107
														Subtotal = $2,640,107

Grand Total All Awards = $56,144,651

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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

Award Number: U01NS080168

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 03/15/2014

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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