Trevo Aspiration Proximal Flow Control Registry "TRAP"

Enrolling by invitation

Phase N/A Results N/A

Trial Description

This purpose of this retrospective, single-arm, non-randomized, multi-center study is to collect real-world data on the effectiveness of using the TRAP technique in acute ischemic stroke patients undergoing mechanical thrombectomy.

Detailed Description

The TRAP Registry is designed to collect real-world data on the use of the TRAP technique for mechanical thrombectomy in stroke patients. Recanalization success (as assessed using a TICI Score), along with the time to recanalization and number of passes needed for success will be assessed at the conclusion of the procedure. In addition, neurologic recovery (as evaluated using the Modified Rankin Scale and National Institutes of Health Score) will be assessed at 24 hours, discharge, and 90 days after the thrombectomy procedure.

Conditions

Interventions

  • TRAP Device
    Intervention Desc: Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.
    ARM 1: Kind: Experimental
    Label: Treated Subjects
    Description: Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA) and in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel and that meet the other inclusion-exclusion criteria.

Trial Population

Patients presenting with acute ischemic stroke at participating hospitals in which the TRAP technique is used for mechanical thrombectomy.

Outcomes

Type Measure Time Frame Safety Issue
Primary Recanalization after Endovascular Intervention Day 0: Conclusion of Thrombectomy Procedure
Primary Time to Recanalization Day 0: Conclusion of Thrombectomy Procedure
Primary Number of Passes for Recanalization Day 0: Conclusion of Thrombectomy Procedure
Primary Distal Emboli Day 0: Conclusion of Thrombectomy Procedure
Secondary Neurologic Outcomes 90 days after treatment
Secondary Functional Outcomes 90 days after treatment
Secondary Adverse Events Day 1, Day 5-7 and Day 90
Secondary TRAP Technique Day 0: Conclusion of thrombectomy procedure

Sponsors