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โ† Trials
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The CREST-2 Registry

Recruitingn/aAges 18 Years - 80 YearsAllUniversity of Maryland, Baltimore
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In plain words

What the trial is, and whether it could suit you

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 part

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria Asymptomatic patients: Age โ‰ฅ 18 and โ‰ค 80 and any one of the following 1. โ‰ฅ70% stenosis, standard surgical risk for CEA 2. โ‰ฅ70% stenosis, high anatomic risk for CEA 3. โ‰ฅ70% 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) โ‰ค 3; and Ipsilateral transient monocular blindness: amaurosis fugax. \[Source: current Medicare NCD for CAS\] Age โ‰ฅ 18 and โ‰ค 80 and any one of the following 1. โ‰ฅ50% 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. โ‰ฅ70% 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. โ‰ฅ70% stenosis, post-CEA and -CAS - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R 6. โ‰ฅ70% 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"
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What it tests

  • Carotid Artery Stent
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Where

1 site
University of Maryland - Administrative Center
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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