MedTrace Logo

Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours

NCT01692379 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2016-02-03

No results posted yet for this study

Summary

To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is superior to medical management alone in achieving favorable outcome in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke \< 8 hours from symptom onset.

Conditions

  • Acute Stroke

Interventions

DEVICE

Solitaire FR device

Mechanical embolectomy in anterior large vessel occlusion

OTHER

Medical treatment

Standard of care in acute ischemic stroke including intravenous rTPA

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Fundacio Ictus Malaltia Vascular

    lead OTHER

Principal Investigators

  • Antoni Dávalos, MD · Hospital Universitario Germans Trias i Pujol, Barcelona, Spain

  • Tudor Jovin, MD · UPMC Stroke Institute, Pittsburgh, PA, USA

  • Angel Chamorro, MD · Hospital Clinic Barcelona, Barcelona, Spain

  • Joaquin Serena, MD · Hospital Josep Trueta, Girona, Spain

  • Alex Rovira, MD · Hospital Vall D'Hebron, Barcelona, Spain

  • Maria A De Miquel, MD · Hospital de Bellvitge, Barcelona, Spain

  • Luis Sanromán, MD · Hospital Clinic, Barcelona, Spain

  • Erik Cobo, MD · UPC, Barcelona, Spain

  • Carlos Molina, MD · Hospital Vall D'Hebron, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-03-31
Completion
2015-12-31

Countries

  • Spain

Study Locations

More Related Trials

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 NCT01692379 on ClinicalTrials.gov