Recruiting

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT02240862

Conditions

Carotid Artery Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Carotid Artery Stent

Study Details

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

Study ID

NCT02240862

Start date

Feb, 2015

Status verified date

Feb, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

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

Enrollment

8000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Carotid Artery Stent

Placement of a stent within the carotid artery

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kimberlly A Castro-Roberts, MBA, CCRC

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

Locations

University of Maryland - Administrative Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kimberlly A Nordstrom, MBA, CCRC

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

Principal Investigator:

Brajesh K Lal, MD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-02-18.