Cardiology

Recruiting

Baptist Health Lexington

Sara Calhoun

Principal Investigator

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Overview

C2R: CREST-2 Registry
Description

The CREST-2 Registry is a companion to accompany the CREST-2 trial for expansion of Medicare coverage for CAS to include procedures performed as part of C2R on symptomatic and asymptomatic patients beyond those categories covered under the 2005 CMS decision.

Learn more at clinicaltrials.gov
Eligibility Criteria

Inclusion

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]

Exclusion

Patients with any one of the following conditions are ineligible for enrollment in C2R
1. 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"