Comparison of Solitaire to Embotrap to Treat Large Vessel Occlusion in Acute Ischemic Stroke (SOLTRAP Study)

Last updated: August 24, 2022
Sponsor: WellStar Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Cardiac Ischemia

Occlusions

Treatment

N/A

Clinical Study ID

NCT05518240
Sol9058
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects who experienced acute ischemic stroke (AIS), eligible for restoration ofblood flow using a Solitaire or Embotrap device to remove thrombus from theneurovasculature
  2. Occlusion of intracranial cerebral circulation vessel involving the M1, M2 MCA orICA-T (Tandem occlusions will be enrolled)
  3. Subject or subject's legally authorized representative (LAR) has signed the informedconsent form prior to or within 72 hours post-procedure
  4. Subject is willing to comply with the protocol follow-up requirements
  5. The intended technique and treated technique must be one of the following techniquesfor the first thrombectomy pass in the neurovasculature per Instructions for Use (IFU).

Exclusion

Exclusion Criteria:

1.The subject can participate in another clinical trial if the study does not impact theendpoints defined in this protocol given this is a data collection trial. Patients who areunable to comply wit the 90 day follow up in person or via telephone will be excluded fromthe study.

Study Design

Total Participants: 418
Study Start date:
August 24, 2022
Estimated Completion Date:
January 01, 2025

Study Description

The SOLTRAP Study is an investigator initiated two hospital study designed to assess the procedural success and clinical outcomes associated with mechanical thrombectomy using the Medtronic Solitaire Device and the Cerenovous Embotrap device. Both devices are FDA approved for this indication of removal of a thrombus for patients suffering from stroke secondary to a large vessel occlusion.

Data collected will include device used during the procedure, mechanical thrombectomy techniques, time from onset to imaging, imaging to puncture, and overall time from onset to reperfusion as well as quality of life at 90 days post stroke.

The study will enroll up to 418 subjects and will be conducted at Wellstar North Fulton Hospital and Wellstar Kennestone Hospital. The devices will have regulatory authorization to be on the market in the geographic location of both sites.

The duration of the Registry protocol is approximately 24 months

Connect with a study center

  • Wellstar Kennestone Hospital

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Wellstar North Fulton Hospital

    Roswell, Georgia 30076
    United States

    Active - Recruiting

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