Comparison of Solitaire to Embotrap to Treat Large Vessel Occlusion in Acute Ischemic Stroke (SOLTRAP Study)
Status unconfirmed
Conditions studied: Acute Ischemic Stroke
In brief
The primary aim of this study is to assess if there is a difference in first pass reperfusion between the two devices. This is a randomized prospective study to assess if there is a difference in first pass reperfusion at two centers with large mechanical thrombectomy volumes. Data will also be collected on time-to treatment, outcomes and hemorrhagic complications.
Key facts
- Study ID
- NCT05518240
- Run by
- WellStar Health System
- People needed
- 418
- Starts
- 2022-08-24
- Expected to finish
- 2025-01-01
- Last updated by the study team
- 2022-08-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature
- Occlusion of intracranial cerebral circulation vessel involving the M1, M2 MCA or ICA-T (Tandem occlusions will be enrolled)
- Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 72 hours post-procedure
- Subject is willing to comply with the protocol follow-up requirements
- The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions for Use (IFU).
You may not qualify if…
- The subject can participate in another clinical trial if the study does not impact the endpoints defined in this protocol given this is a data collection trial. Patients who are unable to comply wit the 90 day follow up in person or via telephone will be excluded from the study.
Where it is running
- Wellstar Kennestone Hospital — Marietta, Georgia, United States (enrolling)
- Wellstar North Fulton Hospital — Roswell, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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