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Lead site preference
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| Name | Class |
|---|---|
| Stryker Neurovascular | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Subjects | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRAP | Device | Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Recanalization after Endovascular Intervention | Revascularization as assessed via Thrombolysis in Cerebral Infarction (TICI) score (TICI 2b/3) in affected vessels | Day 0: Conclusion of Thrombectomy Procedure |
| Time to Recanalization | The time required to attain recanalization (TICI 2b/3) in affected vessels | Day 0: Conclusion of Thrombectomy Procedure |
| Number of Passes for Recanalization | The total number of passes with the stent retriever need to attain recanalization will be captured. | Day 0: Conclusion of Thrombectomy Procedure |
| Distal Emboli | Incidence of distal emboli (both to affected vessel and new vessel) will be assessed | Day 0: Conclusion of Thrombectomy Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Neurologic Outcomes | Neurologic recovery as assessed by the National Institutes of Health Stroke Scale | 90 days after treatment |
| Functional Outcomes | Neurologic recovery as assessed by the Modified Rankin Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting with acute ischemic stroke at participating hospitals in which the TRAP technique is used for mechanical thrombectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Ajit Puri, MD | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts | Worcester | Massachusetts | 01501 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 90 days after treatment |
| Adverse Events | Incidence of serious procedure-related adverse events will be captured | Day 1, Day 5-7 and Day 90 |
| TRAP Technique | Success of using all components of the TRAP technique will be assessed by questionnaire for the interventionalist | Day 0: Conclusion of thrombectomy procedure |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |