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NCT Number: NCT02781181

Carotid Artery Stenting Without Protection

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.

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Key information

Conditions

Carotid Arteries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adapazari Education and Research Hospital, Adapazarı, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAS with CPD

Device

using a neuroprotection device

CAS without CPD

Other

No Neuroprotection

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.

    Time frame: through hospital admission, an average of 2 days

    peri-procedural in hospital outcome

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 24, 2016
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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