Trevo Aspiration Proximal Flow Control Registry



Status:Enrolling by invitation
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 85
Updated:9/15/2018
Start Date:June 6, 2017
End Date:December 30, 2019

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TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry

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.

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
We found this trial at
1
site
Worcester, Massachusetts 01655
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from
Worcester, MA
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