Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-26 @ 11:35 PM
Study NCT ID:
NCT04305704
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2020-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coated Mongolian Aneurysm Treatment Study 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001733', 'term': 'Bites and Stings'}, {'id': 'D020521', 'term': 'Stroke'}], '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': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-03-09', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Efficacy endpoint', 'timeFrame': '12 months after the intervention', 'description': 'Complete occlusion or the neck remnant of the target aneurysm(s), identified by DSA (Digital subtraction angiography).'}], 'primaryOutcomes': [{'measure': 'Safety endpoint', 'timeFrame': 'Within 30 days after the intervention', 'description': 'Occurence of ischemic or hemorrhagic stroke. Incidence of ischemic or hemorrhagic stroke in the territory supplied by the treated artery.'}], 'secondaryOutcomes': [{'measure': 'Safety endpoint', 'timeFrame': 'Within the first 12 months after the intervention', 'description': 'Occurence of all adverse events and serious adverse events, related directly or indirectly to the intervention, the used device or the required medication.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['p64 MW HPC', 'p48 MW HPC', 'Flow Diverter', 'HPC', 'Outcome', 'Occlusion', 'Stroke'], 'conditions': ['Intracranial Aneurysm', 'Aneurysm', 'Vascular Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/34233547/', 'label': 'Early clinical experience with the p48MW HPC and p64MW HPC flow diverters in the anterior circulation aneurysm using single anti-platelet treatment'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under prasugrel.', 'detailedDescription': 'Title: Observational Registry With p64 MW HPC in Unruptured Anterior Circulation Aneurysms Under prasugrel\n\nPurpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under prasugrel in consecutive patients with unruptured anterior circulation aneurysms.\n\nFollow-up intervals: Independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The target population for this Observational Registry are patients with unruptured intracranial aneurysms suitable for flow diversion on operators' discretion. All patients are tested for the extend of their platelet function inhibition prior treatment using VerifyNow (a point-of-care test).\n\nPatients can be included in the Observational Registry if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one unruptured sidewall aneurysm in the anterior circulation\n* No implant (e.g., stent) in the target vessel segment\n* Age \\>18 years and \\<80 years\n* Not pregnant and in women of childbearing age, on oral contraception for two years following the procedure\n* No participation in another trial\n* No concomitant disease limiting the life expectancy to \\<2 years\n* No allergy to non-ionic contrast medium or to ASA and P2Y12 receptor antagonists\n* No other neurovascular disorder in the same vascular territory requiring treatment in the foreseeable future\n* Ability and willingness to comply with the medication requirements within the study,\n* Ability to understand the goal and risks of this study.\n\nExclusion Criteria:\n\n* Intracranial aneurysm considered not suitable for FD using p64 MW HPC or p48 MW HPC.\n* Aneurysm previously treated with a device in the parent vessel (e.g., stent, flow diverter).\n* Another intracranial procedure scheduled for the following 6 months.\n* Age \\< 18 years and \\> 80 years.\n* Pregnancy possible or confirmed. Patient not able or willing to arrange contraception for 12 months after treatment.\n* Patient not able or willing to adhere to the study protocol.\n* Patient not able or willing to undergo the scheduled follow-up examinations.'}, 'identificationModule': {'nctId': 'NCT04305704', 'acronym': 'COMATS 2', 'briefTitle': 'Coated Mongolian Aneurysm Treatment Study 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Phenox GmbH'}, 'officialTitle': 'Clinical Evaluation of the p64 MW HPC and the p48 MW HPC Flow Diverters in an Observational Registry', 'orgStudyIdInfo': {'id': 'STUD-192207'}}, 'contactsLocationsModule': {'locations': [{'zip': '10th khoroolol-2', 'city': 'Ulaanbaatar', 'state': 'Bayangol District', 'status': 'RECRUITING', 'country': 'Mongolia', 'contacts': [{'name': 'Ganbaatar Rentsenkhuu, Dr.', 'role': 'CONTACT', 'email': 'ganbaatar.neuro@gmail.com'}, {'name': 'Ganbaatar Rentsenkhuu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shastin Central Hospital', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}], 'centralContacts': [{'name': 'Hans Henkes, Prof. Dr.', 'role': 'CONTACT', 'email': 'h.henkes@klinikum-stuttgart.de', 'phone': '+49 711 27834501'}, {'name': 'Andrey Petrov, Dr.', 'role': 'CONTACT', 'email': 'doctorpetrovandrey@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phenox GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}