Trevo Aspiration Proximal Flow Control Registry (TRAP)
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|ClinicalTrials.gov Identifier: NCT03199404|
Recruitment Status : Terminated (Lead site preference)
First Posted : June 26, 2017
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment|
|Stroke, Ischemic||Device: TRAP|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||38 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry|
|Actual Study Start Date :||June 6, 2017|
|Actual Primary Completion Date :||October 3, 2019|
|Actual Study Completion Date :||October 3, 2019|
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.
Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.
- Recanalization after Endovascular Intervention [ Time Frame: Day 0: Conclusion of Thrombectomy Procedure ]Revascularization as assessed via Thrombolysis in Cerebral Infarction (TICI) score (TICI 2b/3) in affected vessels
- Time to Recanalization [ Time Frame: Day 0: Conclusion of Thrombectomy Procedure ]The time required to attain recanalization (TICI 2b/3) in affected vessels
- Number of Passes for Recanalization [ Time Frame: Day 0: Conclusion of Thrombectomy Procedure ]The total number of passes with the stent retriever need to attain recanalization will be captured.
- Distal Emboli [ Time Frame: Day 0: Conclusion of Thrombectomy Procedure ]Incidence of distal emboli (both to affected vessel and new vessel) will be assessed
- Neurologic Outcomes [ Time Frame: 90 days after treatment ]Neurologic recovery as assessed by the National Institutes of Health Stroke Scale
- Functional Outcomes [ Time Frame: 90 days after treatment ]Neurologic recovery as assessed by the Modified Rankin Scale
- Adverse Events [ Time Frame: Day 1, Day 5-7 and Day 90 ]Incidence of serious procedure-related adverse events will be captured
- TRAP Technique [ Time Frame: Day 0: Conclusion of thrombectomy procedure ]Success of using all components of the TRAP technique will be assessed by questionnaire for the interventionalist
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199404
|United States, Massachusetts|
|University of Massachusetts|
|Worcester, Massachusetts, United States, 01501|
|Principal Investigator:||Ajit Puri, MD||UMass Medical School|