| NCT ID | NCT02240862 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Carotid Artery Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 8,000 participants |
| Start Date | 2015-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 8,000 participants in total. It began in 2015-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 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"
Contact & Investigator
Brajesh K Lal, MD
PRINCIPAL INVESTIGATOR
University of Maryland
Frequently Asked Questions
Who can join the NCT02240862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Carotid Artery Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02240862 currently recruiting?
Yes, NCT02240862 is actively recruiting participants. Contact the research team at knordstrom@som.umaryland.edu for enrollment information.
Where is the NCT02240862 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT02240862 clinical trial?
NCT02240862 is sponsored by University of Maryland, Baltimore. The principal investigator is Brajesh K Lal, MD at University of Maryland. The trial plans to enroll 8,000 participants.