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Mechanical Thrombectomy in Acute Ischemic Stroke Beyond the Time of Window

NCT04087382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2020-09-09

No results posted yet for this study

Summary

Background: intravenous alteplase appears to be much less effective at opening proximal occlusions of the major intracranial arteries, which account for more than one third of cases of acute anterior-circulation stroke and expanding time window using mechanical thrombectomy can improve clinical outcome in patients that would have only received conservative treatment.

The aim of this work is to evaluate the effectiveness of endovascular therapy within 24 hours of symptom onset and to compare clinical outcome of endovascular therapy with the standard medical therapy at the end of 3rd month follow up.

Material and Methods 57 subjects presenting with an acute ischemic stroke caused by occlusion of the proximal middle cerebral artery (M1 segment) or Internal carotid artery ( ICA segment) within 24 hours from symptom onset as documented by Ct, and or MRI perfusion were recruited consecutively from 2 University hospitals Ain shams University Hospital (32 Patients) and Aswan University (25 patients). Assessment of each subject was performed using NIHSS, and MRS, Aspect score, before intervention. Follow up was done using the same clinical scale one week and the 3 month after the onset.

Primary outcome NIHSS and MRS at the end of 3 month after the onset. secondary outcome complications (cerebral Hge) and death at 3 months.

Conditions

  • Acute Ischemic Stroke

Interventions

DEVICE

thrombectomy

Transfemoral a microcatheter with its distal end was positioned a few millimeters beyond the distal aspect of the clot, the guide wire was exchanged by Solitaire stent device. The device was held in place when 3 mm was out of the microcatheter. The microcatheter was slowly pulled back to deploy the TR or ST device over the clot.

OTHER

non intervention group

medical treatment (Asprin, statin, nootropic drug)

Sponsors & Collaborators

  • Ain Shams University

    collaborator OTHER

  • Aswan University Hospital

    collaborator OTHER

  • Assiut University

    lead OTHER

Principal Investigators

  • Eman M khedr, Professor · Assiut University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2019-09-01
Completion
2019-10-20

Countries

  • Egypt

Study Locations

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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 NCT04087382 on ClinicalTrials.gov