Trevo Aspiration Proximal Flow Control Registry (TRAP)

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.

Study Overview

• Status: Terminated
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: TRAP

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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01501
      • University of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Stryker Neurovascular
• Investigators: Principal Investigator: Ajit Puri, MD, UMass Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): October 3, 2019
• Study Completion (Actual): October 3, 2019

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: TRAPv1.9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No