Trevo Aspiration Proximal Flow Control Registry

Stopped early

Conditions studied: Stroke, Ischemic

In brief

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.

Key facts

Study ID

NCT03199404

Run by

University of Massachusetts, Worcester

People needed

38

Starts

2017-06-06

Expected to finish

2019-10-03

Last updated by the study team

2019-10-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Massachusetts — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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