Trevo Aspiration Proximal Flow Control Registry

NCT ID: NCT03199404

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2019-10-03

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.

Conditions

Stroke, Ischemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

TRAP

Intervention Type: 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Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.

Interventions

TRAP

Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Neurovascular

INDUSTRY

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Ajit Puri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ajit Puri, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Locations

University of Massachusetts

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

TRAPv1.9

Identifier Type: -

Identifier Source: org_study_id