Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-26 @ 1:49 PM
Study NCT ID:
NCT05904951
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device success', 'timeFrame': '48 hours after index procedure', 'description': 'Measurement: Percentage of lesions among all attempted lesions with:\n\n* Successful device delivery, and\n* Successful inflation, achievement of appropriate diameter, and deflation of the balloon, and\n* Decrease in the percent stenosis after balloon procedure, and\n* No perforation, flow-limiting dissection or reduction in TIMI flow grade, and\n* No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)'}], 'secondaryOutcomes': [{'measure': 'Rate of individual components of device success', 'timeFrame': '48 hours after index procedure'}, {'measure': 'Procedural success:', 'timeFrame': '48 hours after index procedure', 'description': 'o Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction \\[MI\\], and clinically indicated target lesion revascularization \\[CI-TLR\\]).'}, {'measure': 'Rate of Target Lesion Failure (TLF)', 'timeFrame': '48 hours after index procedure', 'description': 'o Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Coronary Disease', 'Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of the present observational study is to collect clinical data on the non-implantable medical device INVADER™ PTCA in the daily use in an unselected population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of all consecutive patients treated with the INVADER™ PTCA at the study sites: all patients who met the inclusion/exclusion criteria were enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be a Turkish citizen,\n* To be \\>18 years of age,\n* Lesion must be successfully crossed with a guidewire without complication,\n* INVADER™ PTCA is used in the primary lesion treated during the procedure,\n* Patient has signed and dated the informed consent.\n\nExclusion Criteria:\n\n* Patients who have a known allergic reaction to any of the composition of INVADER™ PTCA Balloon Dilatation Catheter.\n* Device use not consistent with Instructions for Use (IFU).\n* Patients concurrently participating in another medical device or pharmaceutical clinical trial.'}, 'identificationModule': {'nctId': 'NCT05904951', 'briefTitle': 'The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alvimedica'}, 'officialTitle': 'Balloon Dilatation Catheter for the Dilation of Stenotic Atherosclerotic Lesions in Coronary Artery or Bypass Grafts: Evaluation of Safety and Performance in Everyday Clinical Practice. The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study', 'orgStudyIdInfo': {'id': 'C32104'}}, 'armsInterventionsModule': {'interventions': [{'name': 'INVADER™ PTCA Balloon Dilatation Catheter', 'type': 'DEVICE', 'description': 'INVADER™ PTCA Balloon Dilatation Catheter is a single use, EO sterilized, monorail rapid exchange (RX) coronary angioplasty balloon dilatation catheter. The INVADER™ PTCA has been designed to dilate the stenotic atherosclerotic lesions in coronary arteries or bypass grafts. The INVADER™ PTCA is an interventional, non-surgical device, and considered minimally invasive.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Alvimedica', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alvimedica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}