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Minor Stroke Therapy Evaluation

NCT03796468 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 824

Last updated 2023-08-31

No results posted yet for this study

Summary

Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. Approximately one-quarter of the patients suffering a stroke die within one year after the initial event and stroke is a leading cause of serious long-term disability. Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. However, patients with proximal occlusions may present with a low NIHSS, a proximal intraarterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4.

The evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke is demonstrated, STAIR IX (Stroke Treatment Academic Industry Roundtable) consensus recommendations were developed that outline priorities for future research in EVT.

Conditions

Interventions

OTHER

Best Medical Therapy

The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies. The rescue MT may be performed in case of deterioration within the 24 hours

PROCEDURE

Mechanical Thrombectomy

MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus medical, the MT is performed immediately after the randomization

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Vincent COSTALAT, PU-PH · Hôpital Gui de Chauliac

  • Caroline ARQUIZAN, PH · Hôpital Gui de Chauliac

  • Bertrand LAPERGUE, PH · Hôpital Foch

  • Tudor JOVIN, PU-PH · Cooper Neurological Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2025-07-31
Completion
2025-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT03796468 on ClinicalTrials.gov