RecruitingNCT02240862

The CREST-2 Registry

Sponsor

University of Maryland, Baltimore

Enrollment

8,000 participants

Start Date

Feb 1, 2015

Study Type

OBSERVATIONAL

Conditions

Carotid Artery Diseases

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria14

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

Exclusion Criteria7

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"

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