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.
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.
- 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Desc: Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.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.
Patients presenting with acute ischemic stroke at participating hospitals in which the TRAP technique is used for mechanical thrombectomy.
|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|