Carotid Artery Stenting Without Protection

Carotid Arteries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781181
• Other study ID #: AcibademU
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: March 2020

Study information

• Verified date: April 2020
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Arteries

Intervention

Device:
• CAS with CPD
using a neuroprotection device

Other:
• CAS without CPD
No Neuroprotection

Locations

Country	Name	City	State
Turkey	Adapazari Education and Research Hospital	Adapazari
Turkey	Adiyaman University	Adiyaman
Turkey	Acibadem University	Istanbul
Turkey	Kosuyolu Training and Research Hospital	Istanbul
Turkey	Marmara University	Istanbul
Turkey	Mehmet Akif Ersoy Education and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

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