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NCT01054560 · ClinicalTrials.gov registry record · NA
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
A NA study, sponsored by Medtronic Neurovascular Clinical Affairs.
- Completed
- Registry status
- NA
- Development phase
- 144
- Enrollment target
NCT01054560: Completed NA study, sponsored by Medtronic Neurovascular Clinical Affairs.
NCT01054560 is a NA study that has completed, run by Medtronic Neurovascular Clinical Affairs. The registered enrollment target is 144 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01054560, a NA study, has completed, sponsored by Medtronic Neurovascular Clinical Affairs.
- COMPLETED
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
Study 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.
Primary Outcome
Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes. Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy. TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but
Interventions
- DEVICE SOLITAIRE™ Device
- DEVICE MERCI® Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-07 |
| Phase | NA |
What the finished NCT01054560 record still lists
NCT01054560 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which SOLITAIRE™ Device is the first listed.
NCT01054560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01054560 about?
NCT01054560 is a clinical study titled "SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study". 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...
What is the current status of trial NCT01054560?
This trial is currently completed. It is a NA study. The enrollment target is 144 participants. The study started on 2010-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01054560?
The interventions under investigation include: SOLITAIRE™ Device (DEVICE), MERCI® Device (DEVICE).
Who is sponsoring clinical trial NCT01054560?
This trial is sponsored by Medtronic Neurovascular Clinical Affairs, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01054560's enrollment target sits among peer trials
144 706th of 2000 higher than 1,290 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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