Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT07214220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-17
First Post:
2025-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2025-10-01', 'studyFirstSubmitQcDate': '2025-10-06', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Adverse Events', 'timeFrame': 'peri-procedural', 'description': 'All peri-procedural adverse events (AE) from the index procedure.'}, {'measure': 'Effectiveness', 'timeFrame': 'peri-procedural', 'description': 'Image quality, defined as clear image length (CIL) for images obtained during the index procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intracranial aneurysm treatment', 'OCT'], 'conditions': ['Intracranial Aneurysm']}, 'descriptionModule': {'briefSummary': 'This is an investigational study for a new medical device called the nOCT (neuro optical coherence tomography) Imaging System, which is manufactured by Spryte Medical, LLC. The nOCT Imaging System takes pictures from inside a blood vessel in your brain. These pictures give your doctor information about the inside of your blood vessel including the disease and any implanted devices.\n\nThe nOCT Imaging System consists of a probe and a console. The probe is a small, flexible wire-like device designed to navigate through catheters which have already been inserted in your body as part of your planned procedure. Catheters are small, flexible, tubes inserted in your blood vessels which allow your doctor to deliver treatments such as medications, coils, or stents directly to the affected area. The console is a unit that includes a computer, screen and laser light source. The probe is connected to the console. The console provides the probe with low-power light from the laser which is used to scan and create pictures of your blood vessel. The pictures are displayed on the screen of the console for review by your doctor and may be stored for future viewing.\n\nThe objective of the study is to evaluate the safety and effectiveness of the nOCT Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubject age ≥ 18 and ≤ 75 years\n\nSubject has a pre-procedure mRS ≤ 3\n\nSubject is undergoing a planned treatment for an intracranial aneurysm, unruptured or ruptured\n\nSubject understands the investigational procedure, consents to participation, is willing to comply with study follow-up requirements and provides a signed informed consent document\n\nParent artery has a diameter ≥ 1.3 mm and ≤ 6.0 mm as measured by angiography.\n\nExclusion Criteria:\n\nSubjects with a minimum platelet count of \\< 100,000/μL.\n\nSubjects who have suffered an ischemic stroke or transient ischemic attack within the past 30 days.\n\nSubject has an acutely ruptured aneurysm with a Hunt \\& Hess score ≥ 4\n\nSubject has an infectious, blister-like, fusiform, dissecting, traumatic or mycotic aneurysm confirmed by angiography\n\nSubject has challenging anatomy that in the investigator\'s opinion is not suitable for safe delivery of an 0.021" catheter, including stenosis \\> 70% or excessive tortuosity\n\nSubject presents with other medical or surgical co-morbidities limiting his/her life expectancy to less than one year\n\nSubject is, in the opinion of the investigator, unlikely to comply with the study protocol or follow-up requirements.\n\nSubject with any condition which in the opinion of the treating physician would place the subject at an elevated risk of embolic stroke\n\nSubject with known allergy or other contraindication to heparin, iodinated contrast, or dual-antiplatelet medication\n\nSubject has ipsilateral carotid or vertebral artery stenosis greater than 50%\n\nSubject underwent stenting, angioplasty, or endarterectomy procedures of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment.\n\nSubject has serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk\n\nSubject has severe intracranial vasospasm not responsive to medical therapy\n\nSubject has chronic kidney disease stage ≥ 4 and is not undergoing dialysis\n\nThe subject is pregnant or breastfeeding at the time of admission or plans to become pregnant during their participation in the trial\n\nSubject is currently participating in another clinical research trial involving an investigational device or drug\n\nSubject is under judicial protection or legal guardianship'}, 'identificationModule': {'nctId': 'NCT07214220', 'acronym': 'INSYTE', 'briefTitle': 'Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spryte Medical'}, 'officialTitle': 'Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation', 'orgStudyIdInfo': {'id': 'CIP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm: Use of nOCT during treatment and follow-up', 'description': 'Use of nOCT during intracranial aneurysm treatment and subsequent follow-up', 'interventionNames': ['Procedure: Endovascular Intracranial aneurysm treatment', 'Device: nOCT imaging']}], 'interventions': [{'name': 'Endovascular Intracranial aneurysm treatment', 'type': 'PROCEDURE', 'description': 'Endovascular Intracranial aneurysm treatment using devices such as coils, flow diverters, etc. The treatment will include devices that are all FDA approved.', 'armGroupLabels': ['Single arm: Use of nOCT during treatment and follow-up']}, {'name': 'nOCT imaging', 'type': 'DEVICE', 'description': 'During the aneurysm treatment and during the subsequent follow-up, nOCT imaging will be performed.', 'armGroupLabels': ['Single arm: Use of nOCT during treatment and follow-up']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD sharing plans are under evaluation pending sponsor policy and regulatory guidance'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spryte Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}