Trevo Aspiration Proximal Flow Control Registry

NCT03199404 | Terminated

• 1 other identifier: TRAPv1.9
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Neurologic Outcomes

  90 days after treatment

• Functional Outcomes

  90 days after treatment

• Adverse Events

  Day 1, Day 5-7 and Day 90

• TRAP Technique

  Day 0: Conclusion of thrombectomy procedure

Study Arms (1)

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

Interventions

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Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.

Treated Subjects

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Stryker Neurovascular: collaborator

Study Sites (1)

University of Massachusetts

Worcester, Massachusetts, 01501, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ajit Puri, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 26, 2017
• Study Start: June 6, 2017
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

US (1)