Clinical trial NCT03199404: Trevo Aspiration Proximal Flow Control Registry
Official title: TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke, Ischemic
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Stryker Neurovascular
First posted: 2017-06-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with acute ischemic stroke at participating hospitals in which the TRAP technique is used for mechanical thrombectomy.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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)
* Subjects in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel
* Subjects that range in age from 18-85
* Subjects with a prestroke modified Rankin scale of 0-1 and presenting with an NIHSS of 8-30
* Subjects that the operator feels may be treated with endovascular therapy
* Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better
* Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration)
* Subjects who have consented in accordance with local Institutional Review Board requirements

Exclusion Criteria:

* Absence of large vessel occlusion on neuroimaging
* Evidence of tandem occlusion on neuroimaging
* Platelet count \< 100 x 10³ cells/mm³ or known platelet dysfunction
* Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging)
* Previously documented contrast allergy that is not amenable to medical treatment
* Women who are pregnant or breastfeeding at time of intervention
* Evidence of brain hemorrhage on CT and/or MRI at presenting hospital

Primary outcomes:
measure: Recanalization after Endovascular Intervention
timeFrame: Day 0: Conclusion of Thrombectomy Procedure
measure: Time to Recanalization
timeFrame: Day 0: Conclusion of Thrombectomy Procedure
measure: Number of Passes for Recanalization
timeFrame: Day 0: Conclusion of Thrombectomy Procedure
measure: Distal Emboli
timeFrame: Day 0: Conclusion of Thrombectomy Procedure
Secondary outcomes:
measure: Neurologic Outcomes
timeFrame: 90 days after treatment
measure: Functional Outcomes
timeFrame: 90 days after treatment
measure: Adverse Events
timeFrame: Day 1, Day 5-7 and Day 90
measure: TRAP Technique
timeFrame: Day 0: Conclusion of thrombectomy procedure
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Ajit Puri, MD
role: PRINCIPAL_INVESTIGATOR
References: