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Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial

NCT01657461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2017-05-18

Study results available
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Summary

The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)

Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)

DEVICE

Solitaire revascularization device

Clot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator

Sponsors & Collaborators

  • Medtronic Neurovascular Clinical Affairs

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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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 NCT01657461 on ClinicalTrials.gov