Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-01-11 @ 1:29 PM
Study NCT ID:
NCT03199404
Status:
TERMINATED
Last Update Posted:
2019-10-21
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trevo Aspiration Proximal Flow Control Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Lead site preference', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-16', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recanalization after Endovascular Intervention', 'timeFrame': 'Day 0: Conclusion of Thrombectomy Procedure', 'description': 'Revascularization as assessed via Thrombolysis in Cerebral Infarction (TICI) score (TICI 2b/3) in affected vessels'}, {'measure': 'Time to Recanalization', 'timeFrame': 'Day 0: Conclusion of Thrombectomy Procedure', 'description': 'The time required to attain recanalization (TICI 2b/3) in affected vessels'}, {'measure': 'Number of Passes for Recanalization', 'timeFrame': 'Day 0: Conclusion of Thrombectomy Procedure', 'description': 'The total number of passes with the stent retriever need to attain recanalization will be captured.'}, {'measure': 'Distal Emboli', 'timeFrame': 'Day 0: Conclusion of Thrombectomy Procedure', 'description': 'Incidence of distal emboli (both to affected vessel and new vessel) will be assessed'}], 'secondaryOutcomes': [{'measure': 'Neurologic Outcomes', 'timeFrame': '90 days after treatment', 'description': 'Neurologic recovery as assessed by the National Institutes of Health Stroke Scale'}, {'measure': 'Functional Outcomes', 'timeFrame': '90 days after treatment', 'description': 'Neurologic recovery as assessed by the Modified Rankin Scale'}, {'measure': 'Adverse Events', 'timeFrame': 'Day 1, Day 5-7 and Day 90', 'description': 'Incidence of serious procedure-related adverse events will be captured'}, {'measure': 'TRAP Technique', 'timeFrame': 'Day 0: Conclusion of thrombectomy procedure', 'description': 'Success of using all components of the TRAP technique will be assessed by questionnaire for the interventionalist'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with acute ischemic stroke at participating hospitals in which the TRAP technique is used for mechanical thrombectomy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Subjects in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel\n* Subjects that range in age from 18-85\n* Subjects with a prestroke modified Rankin scale of 0-1 and presenting with an NIHSS of 8-30\n* Subjects that the operator feels may be treated with endovascular therapy\n* 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\n* Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration)\n* Subjects who have consented in accordance with local Institutional Review Board requirements\n\nExclusion Criteria:\n\n* Absence of large vessel occlusion on neuroimaging\n* Evidence of tandem occlusion on neuroimaging\n* Platelet count \\< 100 x 10³ cells/mm³ or known platelet dysfunction\n* Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging)\n* Previously documented contrast allergy that is not amenable to medical treatment\n* Women who are pregnant or breastfeeding at time of intervention\n* Evidence of brain hemorrhage on CT and/or MRI at presenting hospital'}, 'identificationModule': {'nctId': 'NCT03199404', 'acronym': 'TRAP', 'briefTitle': 'Trevo Aspiration Proximal Flow Control Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry', 'orgStudyIdInfo': {'id': 'TRAPv1.9'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treated Subjects', 'description': '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.', 'interventionNames': ['Device: TRAP']}], 'interventions': [{'name': 'TRAP', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treated Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01501', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Ajit Puri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Neurovascular', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ajit Puri', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}