Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-11 @ 8:03 PM
Study NCT ID:
NCT06498960
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006850', 'term': 'Hydrocephalus, Normal Pressure'}], 'ancestors': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017287', 'term': 'Ventriculoperitoneal Shunt'}], 'ancestors': [{'id': 'D002557', 'term': 'Cerebrospinal Fluid Shunts'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Endpoint', 'timeFrame': '6 months', 'description': 'The Primary Effectiveness Endpoint of this study is change in gait impairment at 6-months, compared to baseline. Change in gait impairment is defined as reduction in time required to complete the Timed Up and Go (TUG) test (stand up, walk 3m, turnaround, walk 3m, sit down).'}, {'measure': 'Primary Safety Endpoint', 'timeFrame': '6 months', 'description': 'All adverse events will be reported for the investigational (eShunt System) and control (VP shunt) arms. Safety will be analyzed based on a review of all AEs in the investigational arm compared to the control arm, through 6-months post-procedure to demonstrate an acceptable safety profile of the eShunt System.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Normal Pressure Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.', 'detailedDescription': 'The STRIDE study is a prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEach subject must meet the following criteria:\n\n1. Patients ≥60 years old on the day of study informed consent\n2. Patient or legally authorized representative is able and willing to provide written informed consent\n3. History or evidence of gait impairment with a duration ≥3 months\n4. Clinical presentation consistent with NPH including two or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with all of the following:\n\n 1. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \\>0.3) and the absence of severe hippocampal atrophy,\n 2. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%,\n 3. CSF opening pressure ≥8 cmH2O,\n 4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12\n5. Patient is willing and able to attend all scheduled visits and comply with study procedures.\n6. Confirmation of anatomy suitable for the eShunt procedure, as determined by evaluation of pre-procedure imaging (CT and MRI) and approved by an independent anatomical screening committee.\n\nExclusion Criteria:\n\nEach subject may not:\n\n1. Be unable to walk 10 meters (33 feet) with or without an assistive device\n2. Be diagnosed with obstructive hydrocephalus\n3. Have an active systemic infection or infection detected in CSF\n4. Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus\n5. Demonstrate hypersensitivity or contraindication to heparin or radiographic contrast agents against which the subject cannot be adequately pre-medicated, desensitized or where no alternative is available\n6. Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS\n7. Present with venous distension in the neck on physical exam\n8. Have medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arteriovenous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain\n9. Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency\n10. Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure\n11. Have documented evidence of a deep vein thrombosis superior to the popliteal vein\n12. Have intrinsic blood clotting disorder\n13. Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure\n14. Have presence of a posterior fossa tumor or mass\n15. Have a life expectancy \\<1 year\n16. Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.\n17. Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia\n18. Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation\n19. Need an intracranial neurosurgical procedure within 180 days of study index procedure\n20. Be unwilling or unable to comply with follow-up requirements\n21. Have mRS of 0, 5, or 6"}, 'identificationModule': {'nctId': 'NCT06498960', 'acronym': 'STRIDE', 'briefTitle': 'Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus', 'organization': {'class': 'INDUSTRY', 'fullName': 'CereVasc Inc'}, 'officialTitle': 'Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus', 'orgStudyIdInfo': {'id': 'CLIN 0036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eShunt System', 'description': 'Endovascular placement of the eShunt Implant', 'interventionNames': ['Device: CereVasc eShunt System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VP Shunt', 'description': 'Surgical ventriculo-peritoneal shunt procedure', 'interventionNames': ['Device: VP Shunt']}], 'interventions': [{'name': 'CereVasc eShunt System', 'type': 'DEVICE', 'otherNames': ['eShunt System', 'eShunt Implant'], 'description': 'The eShunt System consists of the following components:\n\n* eShunt Implant\n* eShunt Delivery Catheter and Transfer Tool\n* eShunt Anchor', 'armGroupLabels': ['eShunt System']}, {'name': 'VP Shunt', 'type': 'DEVICE', 'description': 'Control arm - VP shunt', 'armGroupLabels': ['VP Shunt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Hu', 'role': 'CONTACT', 'email': 'kelly.hu@med.usc.edu'}, {'name': 'Kasra Khatibi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsey Fraczkiewicz', 'role': 'CONTACT', 'email': 'lindsey.fraczkiewicz@yale.edu'}, {'name': 'Ryan Hebert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jefferson Atillo, RN, BSN', 'role': 'CONTACT', 'email': 'jefferson.atillo@bmcjax.com'}, {'name': 'Ricardo Hanel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baptist Medical Center - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shalini Nampally', 'role': 'CONTACT', 'email': 'snampally@tgh.org'}, {'name': 'Naomi Abel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pouya Nazari', 'role': 'CONTACT', 'email': 'pouya.nazari@northwestern.edu'}, {'name': 'Matthew B. Potts, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gina Littlejohn, BSN, RN, CCRC', 'role': 'CONTACT', 'email': 'Gina.Littlejohn@aah.org', 'phone': '847-723-2099'}, {'name': 'Demetrius Lopes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advocate Lutheran General Hospital', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caliel Hines', 'role': 'CONTACT', 'email': 'calhines@iu.edu'}, {'name': 'Bradley Bohnstedt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Max Hardenbrook', 'role': 'CONTACT', 'email': 'mhardenbrook@kumc.edu'}, {'name': 'Koji Ebersole, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Norris', 'role': 'CONTACT', 'email': 'rachel.norris@uky.edu'}, {'name': 'Justin Fraser, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky Research Foundation', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shayna Hollander', 'role': 'CONTACT', 'email': 'sdhollander@mgh.harvard.edu'}, {'name': 'Aman Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Odysseas Nikas', 'role': 'CONTACT', 'email': 'onikas@bwh.harvard.edu'}, {'name': 'Mohammad Aziz-Sultan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Rotondo, MS', 'role': 'CONTACT', 'email': 'mrotondo@bidmc.harvard.edu'}, {'name': 'Christopher Ogilvy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rehnuma Newaz', 'role': 'CONTACT', 'email': 'rnewaz1@hfhs.org'}, {'name': 'Pouya Entezami, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Health', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sean Behnke', 'role': 'CONTACT', 'email': 'Behnke-sean@cooperhealth.edu'}, {'name': 'Ajith Thomas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cooper Neurological Institute', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia Zajaceskowski', 'role': 'CONTACT', 'email': 'zajacej@amc.edu'}, {'name': 'Alexandra Paul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Carl', 'role': 'CONTACT', 'email': 'ecarl@ubns.com'}, {'name': 'Adnan Siddiqui, MD, PhD, FAHA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University at Buffalo Neurosurgery', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ajith Vellat', 'role': 'CONTACT', 'email': 'avellat1@northwell.edu'}, {'name': 'Mark B. Eisenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Sclafani', 'role': 'CONTACT', 'email': 'michelle.sclafani@nyulangone.org'}, {'name': 'Howard Riina, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin Buttet', 'role': 'CONTACT', 'email': 'kevin.buttet@mountsinai.org'}, {'name': 'Christopher Kellner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Peter Morgenstern, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Massimo', 'role': 'CONTACT', 'email': 'smassimo@northwell.edu'}, {'name': 'Yafell Serulle, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tilor Hallquist', 'role': 'CONTACT', 'email': 'Tilor_Hallquist@URMC.Rochester.edu'}, {'name': 'Tarun Bhalla, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lyanna Gomez, MD', 'role': 'CONTACT', 'email': 'lygomez@montefiore.org'}, {'name': 'David Altschul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joyce Barmen', 'role': 'CONTACT', 'email': 'BARMENJ2@ccf.org'}, {'name': 'Mark Bain, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Sha'Mere Herder", 'role': 'CONTACT', 'email': 'shamere.herder@jefferson.edu'}, {'name': 'Pascal M Jabbour, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wendy Smith, BS, RTRCV, CCRP', 'role': 'CONTACT', 'email': 'wsmith@brownhealth.org'}, {'name': 'Mahesh Jayaraman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Erickson', 'role': 'CONTACT', 'email': 'amy.e.stout@vcuhealth.org'}, {'name': 'Mally Jones', 'role': 'CONTACT', 'phone': 'mallory.jones@vcuhealth.org'}, {'name': 'John Reavey-Cantwell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': 'C1426B', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Carlos Toranzo', 'role': 'CONTACT', 'email': 'ctoranzo@lylyk.com.ar'}, {'name': 'Pedro Lylyk, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica La Sagrada Familia', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'M5C 2W6', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Eileen Liu', 'role': 'CONTACT', 'email': 'Eileen.liu@unityhealth.to'}, {'name': 'Vitor Mendes Pereira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Ona Whelove', 'role': 'CONTACT', 'email': 'clinicaltrials@cerevasc.com', 'phone': '917-275-5340'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CereVasc Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}