Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-16 @ 6:32 AM
Study NCT ID:
NCT05445258
Status:
TERMINATED
Last Update Posted:
2022-09-08
First Post:
2022-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Design of the study device will be modified', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-07-04', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerance', 'timeFrame': 'up to 30 days after intervention', 'description': 'Number of events, which are related to the medical device being tested'}], 'secondaryOutcomes': [{'measure': 'Procedural success', 'timeFrame': 'till the end of the procedure', 'description': 'defined as technical success (ability of the InnoCath AB® hyper-compliant bal-loon catheter to perform as intended, inflation of the device at the lesion site and retraction of the balloon catheter through the introductory sheath) in the ab-sence of vessel rupture, distal embolization, thrombosis, access complications, and major adverse cardiovascular events (cardiac death, myocardial infarction, stroke) as a consequence of the procedure and related to the study device till the end of the procedure'}, {'measure': 'Handling of the InnoCath AB® hyper-compliant balloon catheter', 'timeFrame': 'throughout the entirety of the procedure', 'description': 'The handling of the InnoCath AB® hyper-compliant balloon catheter will be evaluated by the investigator, who assesses various parameters using a scale from 0-2, where 0 describes the better outcome; e.g. balloon deflation and withdrawal of balloon catheter: 0=easy, without any problems, 1=difficult, abnormal, 2=not possible.'}, {'measure': 'Device deficiencies of the InnoCath AB® hyper-compliant balloon catheter', 'timeFrame': 'throughout the entirety of the procedure', 'description': 'The device deficiencies of the InnoCath AB® hyper-compliant balloon catheter will be assessed by the investigator as free-text. Device deficiencies means any inadequacy in the identity, quali-ty, durability, reliability, safety or performance of an investigational device, including malfunc-tion, use errors or inadequacy in information supplied by the manufacturer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II']}, 'descriptionModule': {'briefSummary': "This is a 'first in man' study to demonstrate compliance with the general safety and performance requirements of Regulation (EU) 2017/745 on medical devices (MDR) Annex I as part of the clinical evaluation and for the application of CE-marking. The aim of the study is to evaluate the safety and tolerability of the application and the success rate of the InnoCath AB® hyper-compliant balloon catheter after PTA in peripheral arteries."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* Patients with peripheral arterial occlusive disease and intended for endovascular therapy in the SFA and/or popliteal artery pars I/II\n* Patients suitable for endovascular therapy in the SFA and/or popliteal artery pars I/II with a hyper-compliant balloon without further luminal widening\n* Target vessels with a sufficient "runoff" to the foot with at least one vessel\n* Rutherford classification 1-4 if physical and medicinal therapies have not been successful\n\nExclusion Criteria:\n\n* Aneurysms at the site of inflation\n* Application directly in the area of large vessel wall injuries with heavy bleeding\n* Rutherford classification 5 and 6'}, 'identificationModule': {'nctId': 'NCT05445258', 'acronym': 'HYPER', 'briefTitle': 'Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon', 'organization': {'class': 'INDUSTRY', 'fullName': 'InnoRa GmbH'}, 'officialTitle': 'Evaluation of the Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon Catheters in Peripheral Arteries', 'orgStudyIdInfo': {'id': 'InnoCathAB®_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'InnoCath AB® Balloon', 'description': 'endovascular treatment of lesions in the superficial femoral artery (SFA) and/or popliteal artery pars I/II without further luminal widening, and/or for short-term interruption of blood flow with the InnoCath AB® hyper-compliant balloon cathe-ters (100 or 200 mm length)', 'interventionNames': ['Device: InnoCath AB® hyper-compliant balloon catheter']}], 'interventions': [{'name': 'InnoCath AB® hyper-compliant balloon catheter', 'type': 'DEVICE', 'description': 'endovascular treatment of lesions in the superficial femoral artery (SFA) and/or popliteal artery pars I/II without further luminal widening, and/or for short-term interruption of blood flow with the InnoCath AB® hyper-compliant balloon cathe-ters (100 or 200 mm length)', 'armGroupLabels': ['InnoCath AB® Balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14129', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinik für Diagnostische und Interventionelle Radiologie Evangelisches Krankenhaus Hubertus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14193', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinik für Radiologie und Nuklearmedizin Martin-Luther-Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Michael Werk, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Martin-Luther-Krankenhaus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InnoRa GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}