Clinical trial NCT02781181: Carotid Artery Stenting Without Protection
Official title: Carotid Artery Stenting Without Embolic Protection: A Randomized Multicenter Trial (the CASWEP Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Arteries
Keywords: Stenting
Protection device
EPD usage
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 279
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of patients experiencing new ischemic brain lesions on diffusion-weighted magnetic resonance imaging (DWMRI), transient ischemic attack (TIA), Stroke and death events.
timeFrame: through hospital admission, an average of 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Adapazari
country: Turkey
facility: Adapazari Education and Research Hospital
city: Adiyaman
country: Turkey
facility: Adiyaman University
city: İstanbul
country: Turkey
facility: Acibadem University
city: Istanbul
country: Turkey
facility: Koşuyolu Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University
city: Istanbul
country: Turkey
facility: Mehmet Akif Ersoy Education and Training Hospital
Study officials:
affiliation: Acibadem University
name: SEVKET GORGULU, MD
role: STUDY_DIRECTOR
References:
citation: Gorgulu S, Sahin M, Norgaz NT, Pala S, Sari M, Yalcin AA, Sipahi I. Carotid artery stenting without embolic protection: A randomized multicenter trial (the CASWEP trial). Interv Neuroradiol. 2023 Aug;29(4):419-425. doi: 10.1177/15910199221094388. Epub 2022 Apr 26.