Carotid Artery Stenting Without Protection

Carotid Arteries Clinical Trial

Official title: Carotid Artery Stenting Without Embolic Protection: A Randomized Multicenter Trial (the CASWEP Trial)

Status Completed

Clinical Trial Summary

A recent randomized Carotid artery stenting (CAS) trial in which carotid protection device (CPD)s were used to demonstrate equivalence with carotid endarterectomy (CEA) by achieving noninferiority regarding periprocedural risk. However, the clinical efficacy and safety of CPDs are still a matter of controversy. It has been argued that the limited reduction provided by CPDs may be due to the devices themselves. Probably, they serve as sources for emboli during the procedure or removal technique. In general, 30- day adverse outcome for CAS with the use of CPDs seems not to be different from the outcome without CPDs.

Thus, the main goal in this study is to test the hypothesis that CAS without CPD usage is as safe as in those patients who undergo CAS with CPD neuroprotection.

Clinical Trial Description

The Carotid Artery Stenting without Embolic Protection (CASWEP) trial is designed in a prospective, randomized, multi-center fashion to determine if CAS without CPD is feasible and safe in patients with symptomatic or asymptomatic severe carotid stenosis.

Study participants After the exclusion criterias were applied 279 patients were divided as 139 patients in the CAS with CPD arm and 140 patients in the CAS without CPD arm. Our study population includes patients with severe carotid artery stenosis referred to the 3 study center hospitals. ;

Related Conditions & MeSH terms

• Carotid Arteries

• NCT number: NCT02781181
• Study type: Interventional
• Source: Acibadem University
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Completion date: March 2020