The CREST-2 Registry

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Sep 12, 2014

Keywords

ClinConnect Summary

The CREST-2 Registry is a clinical trial that aims to study a treatment for people with carotid artery diseases, which can lead to serious conditions like stroke. The trial will include patients who have either severe symptoms or no symptoms at all. Eligible participants will be adults aged 18 to 80 who have a significant narrowing (stenosis) of their carotid arteries. This narrowing can be diagnosed through imaging tests. For symptomatic patients, this may include those who have had a mini-stroke or certain types of temporary vision loss.

Participants in the trial will undergo a procedure called carotid artery stenting, where a small tube is placed in the artery to help keep it open. The main goal is to see how safe this procedure is, specifically looking for any major complications like stroke or death within 30 days after the treatment. If you or a loved one meet the eligibility criteria and choose to participate, you will be closely monitored for any side effects after the procedure. This trial is not only important for individual patients but will also help improve treatment approaches in the future.

Gender

ALL

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"