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Bridging Thrombolysis Versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke

NCT03192332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2024-11-14

No results posted yet for this study

Summary

Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal vessel occlusion in the anterior circulation has currently become a matter of debate and is a relevant unanswered question in clinical practice.

The main objective is to determine whether subjects experiencing an AIS due to large intracranial vessel occlusion in the anterior circulation will have non-inferior functional outcome at 90 days when treated with direct mechanical thrombectomy (MT) compared to subjects treated with combined IV t-PA and MT.

The secondary objectives are to study causes of mortality, dependency and quality of life in these AIS patients.

Conditions

Interventions

DEVICE

Stent-retriever thrombectomy with revascularization device of the Solitaire™ type

Mechanical thrombectomy with a stent-retriever revascularization device

DRUG

Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA)

Bridging thrombolysis (IV t-PA plus mechanical thrombectomy) according to current European and North American stroke guidelines.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Urs Fischer, Prof. Dr. · Dept. of Neurology, Inselspital Bern

  • Jan Gralla, Prof. Dr. · Dept. of Neuroradiology, Inselspital Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2021-05-14
Completion
2021-08-11

Countries

  • Austria
  • Canada
  • Finland
  • France
  • Germany
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

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 NCT03192332 on ClinicalTrials.gov