Trial Review

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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
Scientific title
The CREST-2 Registry
Secondary ID [1] 0 0
HP-00063876
Universal Trial Number (UTN)
Trial acronym
C2R
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carotid Artery Diseases 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]
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Any stroke or death within 30 days after the stenting procedure.
Timepoint [1] 0 0
30 days

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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"

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
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
8000
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
Maryland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Maryland, Baltimore
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
Government body
Name [2] 0 0
Centers for Medicare and Medicaid Services
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Mayo Clinic
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Society for Vascular Surgery
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
American College of Cardiology
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02240862
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
Brajesh K Lal, MD
Address 0 0
University of Maryland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kimberlly A Nordstrom, MBA, CCRC
Address 0 0
Country 0 0
Phone 0 0
410-706-3941
Fax 0 0
Email 0 0
knordstrom@som.umaryland.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02240862