Registry for carotid artery stenting procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: knordstrom@som.umaryland.edu
• Phone: 410-706-3941

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.