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

> **NIH NIH U01** · MAYO CLINIC  JACKSONVILLE · 2023 · $153,370

## Abstract

CREST-2 Administrative Supplement – Clinical Research Monitor
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). Carotid stent use is FDA-approved for
revascularization of carotid stenosis for patients who meet criteria for being high-risk for complications
from endarterectomy (so-called SAPPHIRE trial-type patients). CREST-2 approved stent operators can
use FDA-approved devices off-label for the indication of revascularization of non-high-risk patients in the
context of the trial through an FDA Investigational Device Exemption (IDE G130221). CREST-2 is a
complex trial from the perspective of protecting human subjects, as there are widely divergent views of
what constitutes equipoise for patients with asymptomatic carotid stenosis, ranging from the view that
nearly everyone requires revascularization to just the opposite. Properly securing written informed
consent is vital for protection of subjects and minimizing crossover events from medicine to
revascularization is vital for ensuring the validity of the science. Monitoring plays a crucial role in
ensuring the protection of subjects and the validity of the science. Monitoring is required for the FDA
and NINDS as well. As of September 18, 2022, CREST-2 has enrolled a total of 2,137 patients: 1143 in the
endarterectomy trial and 994 in the stenting trial. Patients have been enrolled across 182 sites (170 US
and twelve international). Site monitoring has always been a part of the CREST-2 trial. The Covid-19
pandemic forced a dramatic shift in our monitoring from on-site to remote by live video conferencing.
To be cost-effective, the Clinical Coordinating Center has taken on the responsibility of hiring and
managing the monitor rather than outsourcing the responsibility to a Clinical Research Organization.
While this was successful for many years, challenges in the labor force caused us to lose our two
monitors. Currently we are temporizing with three site managers performing quality control checks on
sites. We believe this dilution of their responsibilities has had a negative impact on study-wide
recruitment. We prioritize quality control checks on sites that were recently activated, sites with a high
number of randomizations, and sites with recent randomizations. The proposal included in this
administrative supplement provides a plan and corresponding justification for hiring one full-time
clinical research monitor to provide on-site and remote monitoring for CREST-2 to pursue the following
specific aim: Resume site-level source document verification in the CREST-2 trial for fiscal y...

## Key facts

- **NIH application ID:** 10724282
- **Project number:** 3U01NS080168-10S1
- **Recipient organization:** MAYO CLINIC  JACKSONVILLE
- **Principal Investigator:** Thomas G Brott
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $153,370
- **Award type:** 3
- **Project period:** 2014-03-15 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10724282

## Citation

> US National Institutes of Health, RePORTER application 10724282, Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) (3U01NS080168-10S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10724282. Licensed CC0.

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