Carotid Artery Stenting Without Protection

Not Applicable

Completed

• Conditions: Carotid Arteries
• Interventions: Device: CAS with CPD; Other: CAS without CPD

• Registration Number: NCT02781181
• Lead Sponsor: Acibadem University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-24
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

• Symptomatic patients with ≥ 50% ipsilateral carotid stenosis by angiography, ≥70% by duplex ultrasound, or ≥70% by Computerized tomography (CT) angiography or Magnetic Resonance (MR) angiography if the stenosis on ultrasonography was 50% to 69%.
• Asymptomatic patients with ≥60% stenosis by angiography, ≥70% by ultrasound, or ≥80% by CT angiography or MR angiography if the stenosis on ultrasonography was 50% to 69%.

Exclusion Criteria

• Total occlusion,
• Visible thrombus at the lesion site
• Bleeding diathesis
• Cerebral vascular malformation,
• Degenerative cerebral diseases
• Cerebral tumors
• Illness impeding informed consent
• Life expectancy<2 years
• Previous CEA.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAS with CPD	CAS with CPD	CAS performed under neuroprotection
CAS without CPD	CAS without CPD	CAS without neuroprotection

Primary Outcome Measures

Name	Time	Method
The number of patients experiencing new ischemic brain lesions on diffusion-weighted magnetic resonance imaging (DWMRI), transient ischemic attack (TIA), Stroke and death events.	through hospital admission, an average of 2 days	peri-procedural in hospital outcome

Trial Locations

Locations (6)

Koşuyolu Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Marmara University; 🇹🇷 Istanbul, Turkey

Mehmet Akif Ersoy Education and Training Hospital; 🇹🇷 Istanbul, Turkey

Adiyaman University; 🇹🇷 Adiyaman, Turkey

Acibadem University; 🇹🇷 İstanbul, Turkey

Adapazari Education and Research Hospital; 🇹🇷 Adapazari, Turkey