Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)

Study ID
STU 012011-146

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
David Timaran Montenegro
214-645-0545
david.timaran@utsouthwestern.edu

Principal Investigator
Carlos Timaran

Summary

CREST is a randomized, controlled trial with blinded end-point adjudication. Patients with symptomatic or asymptomatic carotid stenosis were randomly assigned to undergo carotid-artery stenting or carotid endarterectomy. The primary composite end point was stroke, myocardial infarction, or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization. The study enrolled 2,522 patients at 119 sites in North America.

As part of the Amendment VI Protocol for CREST, patient currently enrolled in the long term follow up will be asked to disclosure their Social Security Number (SSN) through the use of Script for Verbal Consent for Amendment VI. This is designed to maximize data collection for all subjects originally treated within the CREST protocol. T his can be done through retrieving records from national databases. However, to access these records it is necessary to request permission to have and use the social security number (SSN) to identify their records in these databases.

Participant Eligibility

Clinical Inclusions
1. Patient age >= 18 years old.
2. Asymptomatic patient with compatible history and findings on physical and neurological exam.
3. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
4. Patient and the patient's physician agree to have the patient return for all required clinical contacts following study enrollment.
5. Patient has been informed of the nature of the study, and has provided written informed consent.
6. Patient is a candidate for CEA and meets all other eligibility requirements.
7. Spanish-speaking subjects will be eligible to participate in the study.
Anatomic Inclusion
a) Symptomatic patients with carotid stenosis >=50% defined as stenosis >=70% by ultrasound or stenosis >=50% by angiography. If the ultrasound indicates 50-69% stenosis, the patient may be randomized on the basis of results from a CT angiogram or MR angiogram IF a radiologist or neuro-imaging specialist documents his/her opinion that a CT angiogram or MR angiogram indicate >= 70% stenosis.
b) Asymptomatic patients with carotid stenosis >=50% defined as stenosis >=70% by ultrasound or stenosis >=60% by angiography. If the ultrasound indicates 50-69% stenosis, the patient may be randomized on the basis of results from a CT angiogram or MR angiogram IF a radiologist or neuro-imaging specialist documents his/her opinion that a CT angiogram or MR angiogram indicate >= 80% stenosis.
c) Target ICA vessel reference diameter must be visually estimated to be >= 4.0 mm and < 9.0 mm. Patients with bilateral carotid stenosis are eligible. An expected ability to deliver the stent to the lesion (absence of excessive tortuosity) must be present