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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518240
• Other study ID #: Sol9058
• Status: Recruiting
• Start date: August 24, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2022
• Source: WellStar Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 418
• Est. completion date: January 1, 2025
• Est. primary completion date: August 7, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Stent Retrievers
Procedure: Embotrap device
• Stent Retriever
Procedure: Solitaire device

Locations

Country	Name	City	State
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	Wellstar North Fulton Hospital	Roswell	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
WellStar Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Disability	assessed by mRS with a good functional outcome defined as mRS of 0-2 for each technique	Day 90 (+14)
Secondary	Excellent functional outcome	defined as mRS 0-1 at Day 90	Day 90 (+14)