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ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

NCT01437774 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2012-09-06

No results posted yet for this study

Summary

The ReStore™ Thrombectomy device restores blood flow in the neurovascular by removing thrombus in patients experiencing ischemic stroke. Patients enrolled in the ReStore Trial will be randomized to treatment with the ReStore™ Thrombectomy Device (investigational treatment) or to treatment with a commercially available thrombectomy device It is expected that the investigational treatment safety profile in terms of clinically significant procedural adverse events will be comparable to the control group.

Conditions

Interventions

DEVICE

thrombectomy (ReStore or Merci)

Each arm will use either ReStore or Merci as the primary thrombectomy device

Sponsors & Collaborators

  • Reverse Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Marilyn M Rymer, MD · Mid America Brain and Stroke Institute, St Lukes Hospital, Kansas City MO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • United States

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 NCT01437774 on ClinicalTrials.gov