Carotid Artery Stenting Without Protection

Acibadem University

Status: Completed

Conditions: Carotid Arteries

Treatments: Device: CAS with CPD; Other: CAS without CPD

Study type: Interventional

Funder types: Other

Identifiers

NCT02781181

AcibademU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 279 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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279 participants in 2 patient groups

CAS with CPD

Other group

Description:

CAS performed under neuroprotection

Treatment:

Device: CAS with CPD

CAS without CPD

Active Comparator group

Description:

CAS without neuroprotection

Treatment:

Other: CAS without CPD