A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection
The primary objective of this study is to evaluate carotid artery stenting (CAS) with and without cerebral protection (CP) to determine if CP improves safety and effectiveness of CAS.
University of Pittsburgh has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection|
- Primary Endpoint
- Safety: The 30-day composite of stroke or death,
- Effectiveness: The percentage of subjects who show evidence of new ischemic injury on diffusion MRI imaging, as well as the amount of infarcted tissue
- Secondary Endpoints
- Successful stent deployment at the target lesion,
- Successful CP device deployment and retrieval,
- Successful resolution of the stenosis (<30% residual stenosis) determined by angiography immediately post-stent placement,
- Access site vascular complications, defined as need for surgical repair or blood transfusion,
- Restenosis (>50% diameter reduction) rates both in-stent or of the adjacent artery determined by carotid ultrasound imaging at 1 year post-procedure,
- Ipsilateral neurologic deficits on neurologic assessments at 24 hours and 30 days post-procedure.
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||January 2007|
This study is a single center, prospective, randomized trial evaluating the safety and effectiveness of CAS with and without CP. The study population will be comprised of subjects with atherosclerotic, post endarterectomy restenotic or other obstructive lesions in native carotid arteries. Other carotid artery pathology not amenable to surgical repair (for example carotid artery dissection) will also be considered. Subjects at high risk for complications from standard CEA will be the target population for this study. High risk status will be confirmed by two physicians, one of whom is a vascular surgeon. Both symptomatic and asymptomatic subjects will be enrolled. This will ensure that the proportion of symptomatic subjects is the same in the two arms of the study. “Symptomatic” is defined in the exclusion criteria. The expected duration of this clinical trial is 3 years.
In this study there are there are two arms that a subject may be randomized to:
Group1: CAS with the use of the RX ACCUNET Group 2: CAS without the use of the RX ACCUNET
**This study has been designed to test whether the addition of CP enhances the safety and effectiveness of CAS.
|United States, Pennsylvania|
|University of Pittsburgh Medical Center Presbyterian &Shadyside Hospitals|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Michel S Makaroun, M.D.||University of Pittsburgh|