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Trevo Aspiration Proximal Flow Control Registry (TRAP)

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ClinicalTrials.gov Identifier: NCT03199404
Recruitment Status : Terminated (Lead site preference)
First Posted : June 26, 2017
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Ajit Puri, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment
Stroke, Ischemic 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : October 3, 2019
Actual Study Completion Date : October 3, 2019

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Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.




Primary Outcome Measures :
  1. Recanalization after Endovascular Intervention [ Time Frame: Day 0: Conclusion of Thrombectomy Procedure ]
    Revascularization as assessed via Thrombolysis in Cerebral Infarction (TICI) score (TICI 2b/3) in affected vessels

  2. Time to Recanalization [ Time Frame: Day 0: Conclusion of Thrombectomy Procedure ]
    The time required to attain recanalization (TICI 2b/3) in affected vessels

  3. Number of Passes for Recanalization [ Time Frame: Day 0: Conclusion of Thrombectomy Procedure ]
    The total number of passes with the stent retriever need to attain recanalization will be captured.

  4. Distal Emboli [ Time Frame: Day 0: Conclusion of Thrombectomy Procedure ]
    Incidence of distal emboli (both to affected vessel and new vessel) will be assessed


Secondary Outcome Measures :
  1. Neurologic Outcomes [ Time Frame: 90 days after treatment ]
    Neurologic recovery as assessed by the National Institutes of Health Stroke Scale

  2. Functional Outcomes [ Time Frame: 90 days after treatment ]
    Neurologic recovery as assessed by the Modified Rankin Scale

  3. Adverse Events [ Time Frame: Day 1, Day 5-7 and Day 90 ]
    Incidence of serious procedure-related adverse events will be captured

  4. TRAP Technique [ Time Frame: Day 0: Conclusion of thrombectomy procedure ]
    Success of using all components of the TRAP technique will be assessed by questionnaire for the interventionalist



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199404


Locations
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United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01501
Sponsors and Collaborators
University of Massachusetts, Worcester
Stryker Neurovascular
Investigators
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Principal Investigator: Ajit Puri, MD UMass Medical School

Additional Information:

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Responsible Party: Ajit Puri, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03199404     History of Changes
Other Study ID Numbers: TRAPv1.9
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases