CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
SOLITAIRE™ Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01054560
NCT01054560N/ACompleted
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SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

Medtronic Neurovascular Clinical Affairs·interventional·Posted Jan 22, 2010·Updated Oct 26, 2016

In Brief

A clinical study evaluating SOLITAIRE™ Device and MERCI® Device for Ischemic Stroke. Completed, enrolled 144 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Stroke
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 22, 2010
Enrollment StartJan 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.4 years ago

Interventions

SOLITAIRE™ Devicedevice

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

MERCI® Devicedevice

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