Registry for carotid artery stenting procedures

The CREST-2 Registry

This study is tracking carotid artery stenting procedures to see how well they work and keep patients safe, focusing on people with serious carotid artery problems.

Quick facts

• Study type: Observational
• Enrollment: 8000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT02240862 on ClinicalTrials.gov

What this trial studies

The CREST-2 Registry aims to facilitate the enrollment of patients into the CREST-2 randomized clinical trial by monitoring carotid artery stenting (CAS) procedures performed by skilled interventionists. It collects data on patients with severe symptomatic and asymptomatic carotid artery occlusive disease, ensuring that only qualified interventionists participate. The registry will track clinical outcomes and complications, focusing on the occurrence of strokes or death within 30 days post-procedure. Data will be gathered through established quality initiatives to maintain high standards of care and safety.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with significant carotid artery stenosis, either symptomatic or asymptomatic, who meet specific risk criteria.

Not a fit: Patients outside the age range of 18 to 80 or those with less than 50% stenosis may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could improve the safety and efficacy of carotid artery stenting procedures for patients with carotid artery diseases.

How similar studies have performed: Other studies utilizing registries for monitoring procedural outcomes have shown success in improving patient safety and care standards.

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"

Where this trial is running

Baltimore, Maryland

• University of Maryland - Administrative Center — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Brajesh K Lal, MD — University of Maryland
• Study coordinator: Kimberlly A Castro-Roberts, MBA, CCRC

Conditions Carotid Artery Diseases