NCT05518240

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 418 (estimated)
• Sponsor: WellStar Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Stent Retrievers	Procedure: Embotrap device
DEVICE	Stent Retriever	Procedure: Solitaire device

Timeline

• Start date: 2022-08-24
• Primary completion: 2024-08-07
• Completion: 2025-01-01
• First posted: 2022-08-26
• Last updated: 2022-08-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study