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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05465122




Registration number
NCT05465122
Ethics application status
Date submitted
30/06/2022
Date registered
19/07/2022
Date last updated
29/08/2023

Titles & IDs
Public title
Long-Term Observational Extension of Participants in CREST-2Trial
Scientific title
Long-Term Observational Extension of Participants in CREST-2
Secondary ID [1] 0 0
1U01NS119169-01A1
Secondary ID [2] 0 0
21-007363
Universal Trial Number (UTN)
Trial acronym
C2LOE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stenoses, Carotid 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Carotid Endarterectomy
Treatment: Surgery - FDA-approved carotid stents
Other interventions - Intensive Medical Management

Carotid Stenting Group (CAS) - Subjects assigned to the intensive medical management with carotid stenting group in the CREST-2 study (NCT02089217)

Carotid Endarterectomy Group (CEA) - Subjects assigned to the intensive medical management with carotid endarterectomy group in the CREST-2 study (NCT02089217)

Intensive Medical Management Group - no CAS - Subjects assigned to the intensive medical management alone with no carotid stenting (CAS) group in the CREST-2 study (NCT02089217)

Intensive Medical Management Group - no CEA - Subjects assigned to the intensive medical management alone with no carotid endarterectomy (CEA) group in the CREST-2 study (NCT02089217)


Treatment: Surgery: Carotid Endarterectomy
This is the standard proven therapy for carotid stenosis that involves an arterotomy followed by removal of plaque and reconstruction of the vessel.

Treatment: Surgery: FDA-approved carotid stents
This is the standard proven therapy for carotid stenosis that involves an arterotomy followed by removal of plaque and reconstruction of the vessel.

Other interventions: Intensive Medical Management
INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stroke
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion criteria
- Currently active or graduated participants in the CREST-2 randomized trial at a site
located in the United States

- Able to provide written informed consent by self

- Fluent in English
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to provide written informed consent

- Inability to follow study procedures

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
2480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Other
Name
Mayo Clinic
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Alabama at Birmingham
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Maryland
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Medical University of South Carolina
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this Long-Term Observational Extension of Participants in the CREST-2
Randomized Clinical Trial (C2LOE - ClinicalTrials.gov Identifier: NCT02089217) study is to
study is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05465122
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
James Meschia, MD
Address 0 0
Mayo Clinic
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05465122