Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-26 @ 12:28 AM
Study NCT ID:
NCT06434194
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2024-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serrantor OCT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2024-05-03', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual Lumen Volume Stenosis', 'timeFrame': 'Baseline', 'description': 'Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated.'}], 'secondaryOutcomes': [{'measure': 'OCT Residual Diameter Stenosis', 'timeFrame': 'Baseline', 'description': 'Residual stenosis as measured by OCT'}, {'measure': 'Angiography Residual Diameter Stenosis', 'timeFrame': 'Baseline', 'description': 'Residual stenosis as measured by angiography'}, {'measure': 'Dissection Pattern', 'timeFrame': 'Baseline', 'description': 'The incidence of dissection pattern between the study arms as reported by the OCT Corelab. The CoreLab will evaluate OCT images of each dissection including analysis of the length of the dissection, arc of the dissection, number of serrations, and the length of the serration.'}, {'measure': 'Correlation of Luminal Gain and Plaque Modification', 'timeFrame': 'Baseline', 'description': 'The correlation of the plaque modification achieved as determine from the OCT evaluation after treatment with the Study Device to the luminal gain achieved by conventional angioplasty as evaluated by the Core Lab.'}, {'measure': 'Rate of Optimal PTA', 'timeFrame': 'Baseline', 'description': 'Rate of procedures that achieve optimal PTA (\\<30% diameter stenosis without flow-limiting dissection measured by angiography)'}, {'measure': 'Bail-out Stenting', 'timeFrame': 'Baseline', 'description': 'Rate of bail-out stenting'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Critical Limb Ischemia']}, 'descriptionModule': {'briefSummary': 'TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rutherford clinical category 4-6 of the target limb\n* Age of subjects is \\>18 years old\n* Patients has given informed consent to participate in this study\n\nExclusion Criteria:\n\n* De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion\n* Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.\n* Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.\n* Lesion length less than 220 mm'}, 'identificationModule': {'nctId': 'NCT06434194', 'briefTitle': 'Serrantor OCT Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cagent Vascular LLC'}, 'officialTitle': 'Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)', 'orgStudyIdInfo': {'id': 'CSP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Serrantor', 'description': 'Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon', 'interventionNames': ['Device: Serranator PTA Serration Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PTA', 'description': 'Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.', 'interventionNames': ['Drug: PTA (Standard of Care)']}], 'interventions': [{'name': 'Serranator PTA Serration Catheter', 'type': 'DEVICE', 'description': 'The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.', 'armGroupLabels': ['Serrantor']}, {'name': 'PTA (Standard of Care)', 'type': 'DRUG', 'description': 'A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.', 'armGroupLabels': ['PTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'K Dalton', 'role': 'CONTACT'}], 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'R Chu', 'role': 'CONTACT'}], 'facility': 'Weill Cornell Medical', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Feeny', 'role': 'CONTACT', 'email': 'kjclinconsulting@gmail.com', 'phone': '4197878496'}, {'name': 'Wittwer', 'role': 'CONTACT', 'email': 'twittwer@mededge.io'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cagent Vascular LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}