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New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis

NCT03764306 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-12-05

No results posted yet for this study

Summary

Background and purpose. Even if periprocedural cerebral microembolism associated with carotid endarterectomy or stenting usually does not manifest as clinically overt stroke, neuropsychological disturbances resulting from these events represent an important clinical and socioeconomic problem. Still, it remains unclear whether the use proximal protection can lower the incidence of cerebral embolism associated with the treatment of carotid stenosis.

Materials and methods. This was a prospective randomised single-centre study, which was aimed at comparison of surgical eversion endarterectomy with stenting under proximal protection in symptomatic patients. The investigators evaluated the incidence of new ischaemic lesions revealed by the diffusion-weighted magnetic resonance imaging 2-4 days after the treatment and neurologic events.

Conditions

  • Carotid Artery Stenosis
  • Carotid Atherosclerosis
  • Stroke, Ischemic

Interventions

PROCEDURE

Carotid Artery Stenting

Carotid artery stenting was considered successful if there was no residual stenosis greater than 20%, and there was no dissection of target artery following the procedure.

PROCEDURE

Endarterectomy carotid artery

Surgical endarterectomy was considered successful if there was no residual stenosis after procedure, without symptoms.

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Pawel Latacz, PhD MD · Jagiellonian University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2015-05-01
Completion
2018-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764306 on ClinicalTrials.gov