The CREST-2 Registry

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT02240862
Status
Recruiting
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Conditions

  • Carotid Artery Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Carotid Artery Stent — DEVICE
    Placement of a stent within the carotid artery

Study Details

The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting (CAS) performed by experienced and skilled interventionists. Interventionists' eligibility will be determined by a multi-specialty Interventional Management Committee (IMC). Patient eligibility will include patients with standard or high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for the occurrence of post-procedural complications. The primary safety and quality endpoint will be the occurrence of any stroke or death within the 30-day period following the stenting procedure. The safety and quality results from C2R will guide selection of interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in 2015 and continue until publication of the primary results of the randomized trial.

Key Dates

Start date
Feb 28, 2015
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
8,000 participants (estimated)

Arms

  • Arm: Carotid Artery Disease
    Patients undergoing carotid artery stenting for high grade carotid artery stenosis with or without neurologic symptoms and with or without a high risk for carotid endarterectomy.

Primary Outcome Measure

Any stroke or death within 30 days after the stenting procedure. [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland - Administrative CenterBaltimoreMaryland21201
Kimberlly A Nordstrom, MBA, CCRC
[email protected]
410-706-3941
Brajesh K Lal, MD (PRINCIPAL_INVESTIGATOR)

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University of Maryland - Administrative Center· Baltimore, MD

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