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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/NCT02240862
Registration number
NCT02240862
Ethics application status
Date submitted
12/09/2014
Date registered
16/09/2014
Date last updated
21/08/2023
Titles & IDs
Public title
The CREST-2 Registry
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Scientific title
The CREST-2 Registry
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Secondary ID [1]
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HP-00063876
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Universal Trial Number (UTN)
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Trial acronym
C2R
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carotid Artery Diseases
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Carotid Artery Stent
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.
Treatment: Devices: Carotid Artery Stent
Placement of a stent within the carotid artery
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Any stroke or death within 30 days after the stenting procedure.
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Assessment method [1]
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Timepoint [1]
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30 days
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Eligibility
Key inclusion criteria
Inclusion Criteria
Asymptomatic patients:
Age = 18 and = 80 and any one of the following
1. =70% stenosis, standard surgical risk for CEA
2. =70% stenosis, high anatomic risk for CEA
3. =70% stenosis, high physiologic risk for CEA
Symptomatic patients:
Symptomatic patients are defined by the following characteristics: Ipsilateral carotid
Transient Ischemic Attack (TIA), with neurologic symptoms persisting less than 24 hours;
Ipsilateral non-disabling stroke: Modified Rankin Scale (mRS) = 3; and Ipsilateral
transient monocular blindness: amaurosis fugax. [Source: current Medicare NCD for CAS]
Age = 18 and = 80 and any one of the following
1. =50% stenosis, standard surgical risk for CEA
2. 50% to 69% stenosis, high anatomic risk for CEA
3. 50% to 69% stenosis, high physiologic risk
4. =70% stenosis, high anatomic and/or physiologic risk for CEA - currently covered by
Medicare, but sites are strongly encouraged to voluntarily include these patients in
C2R
5. =70% stenosis, post-CEA and -CAS - currently covered by Medicare, but sites are
strongly encouraged to voluntarily include these patients in C2R
6. =70% stenosis, post-irradiation - currently covered by Medicare, but sites are
strongly encouraged to voluntarily include these patients in C2R
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with any one of the following conditions are ineligible for enrollment in C2R
1. NYHA Class IV CHF
2. COPD on chronic continuous oxygen therapy
3. Severe (Class Childs D) liver failure
4. End-stage renal failure requiring dialysis
5. Cancer with metastatic spread and/or undergoing active chemotherapeutic treatment
6. Any dementia considered greater than "mild"
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2025
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Actual
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Sample size
Target
8000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Maryland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Maryland, Baltimore
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Institute of Neurological Disorders and Stroke (NINDS)
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Address [1]
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Country [1]
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Other collaborator category [2]
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Government body
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Name [2]
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Centers for Medicare and Medicaid Services
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Mayo Clinic
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Society for Vascular Surgery
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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American College of Cardiology
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02240862
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Trial related presentations / publications
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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
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Contacts
Principal investigator
Name
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Brajesh K Lal, MD
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Address
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University of Maryland
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kimberlly A Nordstrom, MBA, CCRC
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Address
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Country
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Phone
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410-706-3941
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02240862
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