Recruiting

Solitaire vs. Embotrap

Sponsor:

WellStar Health System

Code:

NCT05518240

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stent Retrievers

Stent Retriever

Study Details

Brief 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.

Conditions

Acute Ischemic Stroke

Study ID

NCT05518240

Start date

Aug 24, 2022

Status verified date

Aug, 2022

Completion date

Jan 1, 2025

Anticipated

Primary completion date

Aug 7, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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
2. Occlusion of intracranial cerebral circulation vessel involving the M1, M2 MCA or ICA-T (Tandem occlusions will be enrolled)
3. Subject or subject's legally authorized representative (LAR) has signed the informed consent 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 techniques for the first thrombectomy pass in the neurovasculature per Instructions for Use (IFU).

Exclusion Criteria:

1.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.

Study Design

Enrollment

418 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute ischemic stroke (AIS)

Patients who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature

Interventions

Stent Retrievers

Procedure: Embotrap device

Stent Retriever

Procedure: Solitaire device

Primary outcome measure

  • Severity of Disability [ Time Frame: Day 90 (+14) ]

Central Contacts and Locations

Locations

Wellstar Kennestone Hospital

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Wellstar Research Institute

research@wellstar.org

Principal Investigator:

Benjamin Zussman, MD

Wellstar North Fulton Hospital

Recruiting

Roswell, Georgia, United States, 30076

Contacts

Principal Investigator:

Benjamin Zussman, MD

More Information

Sponsor

WellStar Health System

Last update posted

Aug 26, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by WellStar Health System on 2022-08-26.