Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT05018650
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-24', 'mcpReleaseN': 10, 'releaseDate': '2025-10-14'}], 'estimatedResultsFirstSubmitDate': '2025-10-14'}}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater', 'timeFrame': 'During procedure', 'description': 'mTICI of 2b or greater indicates successful reperfusion following blood clot removal'}, {'measure': 'Incidence of all symptomatic intracerebral hemorrhage (sICH)', 'timeFrame': 'within 24 hours post-procedure', 'description': 'Evaluation of sICH per von Kummer et al'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '40395106', 'type': 'DERIVED', 'citation': 'Nguyen TN, Dabus G, McGuinness B, Caldwell J, Priest R, Rai AT, Zaidat OO, Gross BA, Hanel R, Lee S, Hussain S, Shaikh H, Abdalkader M, Budzik R, Kilburg C, Woodward K, Colasurdo M, Liu J, Yoo AJ, Khandelwal P, Boo S, Vu P, Lin E, Almajali M, Singh J, Al-Bayati A, Lang MJ, Abraham M, Hassan AE, Pema P, Martin C, Grandhi R, Tonetti DA, Hixson HR, Aghaebrahim A, Sauvageau E, Ortega-Gutierrez S, Yavagal DR, Cheng-Ching E, Khalife J, Linfante I, Vulkanov V, Soomro J, Fifi JT, Maidan L, Copelan A, Schirmer CM, Bain M, Toth G, Jayaraman M, Novakovic-White R, Satti S, Villelli N, Jabbour P, Page M, McAllister DJ, Araujo Contreras R, Samaniego EA, Liebeskind DS, Hetts SW, Nogueira RG, English J, Puri AS. SUMMIT MAX: A Randomized Trial of the Super Large Bore HiPoint Reperfusion System Versus Vecta System for Aspiration Thrombectomy. Stroke. 2025 Aug;56(8):1980-1990. doi: 10.1161/STROKEAHA.125.051742. Epub 2025 May 21.'}]}, 'descriptionModule': {'briefSummary': 'The SUMMIT MAX study is a prospective, randomized, controlled, interventional clinical trial to evaluate the safety and effectiveness of the Route 92 Medical MonoPoint® Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters for aspiration thrombectomy in acute ischemic stroke patients.', 'detailedDescription': 'The purpose of the SUMMIT MAX study is to obtain the safety and effectiveness data necessary to demonstrate substantial equivalence of the Route 92 Medical Reperfusion System with a predicate aspiration device to support a 510(k) application to the U.S. Food and Drug Administration (FDA) under the classification product code, NRY.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The consent process has been completed and documented according to applicable country regulations and as approved by the IRB / Ethics Committee\n2. Age \\>=18 years\n3. Patient presenting with clinical signs consistent with an acute ischemic stroke\n4. Baseline National Institutes of Health Stroke Scale (NIHSS) score \\>= 6\n5. Pre-stroke modified Rankin Score (mRS) \\<= 2\n6. Baseline ASPECTS \\>= 6\n7. Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well\n8. If indicated, thrombolytic therapy shall be initiated per clinical guidelines. If eligible for thrombolytic therapy, subjects should be treated as soon as possible and lytic use should not be delayed regardless of potential eligibility for mechanical neurothrombectomy.\n9. The patient is indicated for aspiration neurothrombectomy with the Route 92 Medical Reperfusion System as determined by the Investigator\n10. Angiographic confirmation of a large vessel occlusion of the M1 segment of the middle cerebral artery or distal internal carotid artery\n\nExclusion Criteria:\n\n1. Known pregnancy or breast feeding\n2. In the Investigator's opinion, any known comorbidity (including COVID-19 positivity) that may complicate treatment or prevent improvement or follow-up\n3. Known serious, advanced, or terminal illness with anticipated life expectancy \\< 12 months\n4. Known history of severe allergy to contrast medium\n5. Known to have suffered a stroke in the past 90 days\n6. Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, Ehlers-Danlos syndrome)\n7. Any known previous cerebral hemorrhagic event\n8. Any known pre-existing coagulation deficiency\n9. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \\>3.0\n10. Known baseline platelet count \\<50,000/µL\n11. Known baseline blood glucose of \\<50 mg/dL or \\>400 mg/dL\n12. Known to be participating in another study involving an investigational device or drug\n13. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.\n14. Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh cerebral hemorrhage (the presence of microbleeds is allowed)\n15. Baseline CT or MRI showing intracranial tumor (except small meningioma \\<= 2cm) or significant mass effect with midline shift due to the tumor\n16. Presumed septic thrombus, or suspicion of bacterial endocarditis\n17. Inability to access the cerebral vasculature in the opinion of the neurointerventional team\n18. Unlikely to be available for a 90-day follow-up (e.g. no fixed home address)\n19. Evidence of arterial dissection in a vessel that must be traversed\n20. Evidence of high-grade stenosis or occlusion (i.e., tandem occlusion) in a vessel that must be traversed\n21. Known active or recent history of cocaine or methamphetamine abuse (within last 6 months)\n22. Known history or presence of aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion\n23. For all patients, severe sustained hypertension with SBP \\>200 and/or DBP \\>120; for patients treated with a lytic, sustained hypertension despite treatment with SBP \\>185 and/or DBP \\>110\n24. Treatment with heparin within 48 hours with a partial thromboplastic time more than two times the laboratory normal or treatment with any LMWH within 48 hours\n25. Renal failure with serum creatinine \\>3.0 or Glomerular Filtration Rate (GFR) \\<30\n26. Ongoing seizure due to stroke\n27. Evidence of active systemic infection\n28. Known cancer with metastases\n29. Angiographic evidence of a dissection in the extracranial or intracranial cerebral arteries\n30. Arterial stenosis requiring balloon angioplasty or stenting at the time of the procedure\n31. Angiographic evidence of multiple cerebrovascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation, tandem occlusions)\n32. Angiographic evidence of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion\n33. Angiographic evidence or suspicion of aortic dissection\n34. Angiographic evidence of an aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion"}, 'identificationModule': {'nctId': 'NCT05018650', 'briefTitle': 'A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Route 92 Medical, Inc.'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients (SUMMIT MAX)', 'orgStudyIdInfo': {'id': 'CIP 0974'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Route 92 Medical Monopoint Reperfusion System', 'description': 'Aspiration thrombectomy with the Route 92 Medical HiPoint 88 and HiPoint 70 Reperfusion Catheters as part of the Monopoint Reperfusion System to treat acute ischemic stroke', 'interventionNames': ['Device: Route 92 Medical Reperfusion System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspiration Predicate', 'description': 'Aspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke', 'interventionNames': ['Device: Route 92 Medical Reperfusion System']}], 'interventions': [{'name': 'Route 92 Medical Reperfusion System', 'type': 'DEVICE', 'description': 'Mechanical thrombectomy for acute ischemic stroke patients with large vessel occlusions will be performed with direct aspiration consisting of navigating a large-bore catheter up to the face of the clot and initiating vacuum suction.', 'armGroupLabels': ['Aspiration Predicate', 'Route 92 Medical Monopoint Reperfusion System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Health', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Mercy San Juan Medical Center', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Aurora Health', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Health System', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Hospital', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Health', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45409', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State University', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '43608', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Health St. Vincent', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97219', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Clinic', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37902', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Fort Sanders Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78550', 'city': 'Harlingen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Baptist', 'geoPoint': {'lat': 26.19063, 'lon': -97.6961}}, {'zip': '75075', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical City Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '84123', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Guilherme Dabus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baptist Health - Miami'}, {'name': 'Ajit Puri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}, {'name': 'Thanh Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Route 92 Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}