The CREST-2 Registry

NCT02240862 | Recruiting

• 1 other identifier: HP-00063876
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

• Any stroke or death within 30 days after the stenting procedure.

  30 days

Study Arms (1)

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.

Device: Carotid Artery Stent

Interventions

Carotid Artery Stent DEVICE

Placement of a stent within the carotid artery

Carotid Artery Disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 - 80 years old with symptomatic or asymptomatic carotid artery disease.

You may qualify if:

• Asymptomatic patients:
• Age ≥ 18 and ≤ 80 and any one of the following
• ≥70% stenosis, standard surgical risk for CEA
• ≥70% stenosis, high anatomic risk for CEA
• ≥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
• ≥50% stenosis, standard surgical risk for CEA
• % to 69% stenosis, high anatomic risk for CEA
• % to 69% stenosis, high physiologic risk
• ≥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
• ≥70% stenosis, post-CEA and -CAS - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
• ≥70% stenosis, post-irradiation - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R

You may not qualify if:

• Patients with any one of the following conditions are ineligible for enrollment in C2R
• NYHA Class IV CHF
• COPD on chronic continuous oxygen therapy
• Severe (Class Childs D) liver failure
• End-stage renal failure requiring dialysis
• Cancer with metastatic spread and/or undergoing active chemotherapeutic treatment
• Any dementia considered greater than "mild"

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Centers for Medicare and Medicaid Services: collaborator
• Mayo Clinic: collaborator
• Society for Vascular Surgery: collaborator
• American College of Cardiology: collaborator

Study Sites (1)

University of Maryland - Administrative Center

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brajesh K Lal, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberlly A Castro-Roberts, MBA, CCRC

CONTACT

410-706-3941; knordstrom@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 16, 2014
• Study Start: February 1, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)