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SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

NCT01054560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2016-10-26

Study results available
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Summary

The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.

Conditions

Interventions

DEVICE

SOLITAIRE™ Device

The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure

DEVICE

MERCI® Device

The MERCI® Device is the control device that will be used in the interventional procedure.

Sponsors & Collaborators

  • Medtronic Neurovascular Clinical Affairs

    lead INDUSTRY

Principal Investigators

  • Jeffrey L. Saver, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

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 NCT01054560 on ClinicalTrials.gov