Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:38 AM
Study NCT ID:
NCT07436156
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SUMMIT RISE Study of Acute Ischemic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periprocedural eTICI measurement of revascularization', 'timeFrame': 'Periprocedural', 'description': 'Revascularization status checklist'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Acute Ischemic Stroke'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'SUMMIT RISE Study of Acute Ischemic Stroke Patients', 'detailedDescription': 'SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ischemic stroke patient initially treated (first pass) with a Route 92 Medical Reperfusion System\n* Informed consent completed and documented within 72 hours following thrombectomy procedure\n* Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07436156', 'briefTitle': 'SUMMIT RISE Study of Acute Ischemic Stroke Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Route 92 Medical, Inc.'}, 'officialTitle': 'SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.', 'orgStudyIdInfo': {'id': 'CIP 4262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Route 92 Medical Reperfusion Systems', 'description': 'Aspiration of thrombus using the Route 92 Medical Reperfusion Systems', 'interventionNames': ['Device: Route 92 Medical Reperfusion Systems']}], 'interventions': [{'name': 'Route 92 Medical Reperfusion Systems', 'type': 'DEVICE', 'description': 'Mechanical thrombectomy with the Route 92 Medical Reperfusion Systems', 'armGroupLabels': ['Route 92 Medical Reperfusion Systems']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Renee Kochevar Vice President, Clinical Research, PhD, ALM', 'role': 'CONTACT', 'email': 'reneek@r92m.com', 'phone': '650-581-1179'}], 'facility': 'Route 92 Medical, Inc.', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}], 'centralContacts': [{'name': 'Renee Kochevar Vice President, Clinical Research, PhD, ALM', 'role': 'CONTACT', 'email': 'reneek@r92m.com', 'phone': '650-581-1179'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Depending on trial completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Route 92 Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}