Carotid Artery Stenting Without Protection

NCT02781181 | Completed

• 1 other identifier: AcibademU
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 6

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.

Conditions

Carotid Arteries

Keywords

Stenting; Protection device; EPD usage

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CAS with CPD

OTHER

CAS performed under neuroprotection

Device: CAS with CPD

CAS without CPD

ACTIVE COMPARATOR

CAS without neuroprotection

Other: CAS without CPD

Interventions

CAS with CPD DEVICE

using a neuroprotection device

CAS with CPD

CAS without CPD OTHER

No Neuroprotection

CAS without CPD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (6)

Adapazari Education and Research Hospital

Adapazarı, Turkey (Türkiye)

Location

Adiyaman University

Adıyaman, Turkey (Türkiye)

Location

Acibadem University

Istanbul, Turkey (Türkiye)

Location

Koşuyolu Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Marmara University

Istanbul, Turkey (Türkiye)

Location

Mehmet Akif Ersoy Education and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35469509 DERIVED

Study Officials

• SEVKET GORGULU, MD

  Acibadem University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 24, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (6)