Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT05536167
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2022-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy endpoint', 'timeFrame': 'up to end of procedure', 'description': 'successful debris aspiration (macroscopic observation of the retrieved material in the filter) during the procedure.'}, {'measure': 'Safety endpoint', 'timeFrame': 'up to end of procedure', 'description': 'insertion and retrieval of the catheter up to the treated vessel without complication.'}], 'secondaryOutcomes': [{'measure': 'Performance - TIMI flow grade', 'timeFrame': 'up to end of procedure', 'description': 'Final Thrombolysis In Myocardial Infarction (TIMI) Flow Grade at procedure'}, {'measure': 'Safety - absence of complications', 'timeFrame': 'up to end of procedure', 'description': 'Absence of complications during hospitalization (per standard hospital of care): cardiovascular death, recurrent myocardial infarction, cardiogenic shock, worsening of TIMI flow due to aspiration catheter, new or worsening New York Heart Association (NYHA) Class IV heart failure,'}, {'measure': 'Performance - TIMI thrombus grade', 'timeFrame': 'up to end of procedure', 'description': 'Final TIMI Thrombus Grade at procedure'}, {'measure': 'Performance', 'timeFrame': 'up to end of procedure', 'description': 'Distal Embolization Rate at procedure'}, {'measure': 'Safety - absence of Serious Adverse Event', 'timeFrame': 'up to end of procedure', 'description': 'Incident of Device Related SAEs during aspiration catheter use'}, {'measure': 'Safety - absence of stroke', 'timeFrame': 'up to end of procedure', 'description': 'Stroke during aspiration catheter use (per hospital standard of care).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts']}, 'descriptionModule': {'briefSummary': 'The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing PTA/PTCA and/or stenting procedures and presenting thrombus in the central and peripheral circulatory system, including saphenous vein grafts.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):\n\n 1. Patient with a percutaneous intervention to a native coronary, saphenous vein graft, or peripheral arteries;\n 2. Patient with angiographic evidence of thrombus;\n 3. Patient \\> or = 50 kg;\n 4. Patient \\>18 years;\n 5. Patient who understands the trial requirements and the treatment procedures and provides written informed consent.\n\nExclusion Criteria:\n\n* Patients will be excluded as per IFU, Hospital standard of care and GCP, also if there are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.'}, 'identificationModule': {'nctId': 'NCT05536167', 'briefTitle': 'Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arthesys'}, 'officialTitle': 'Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family', 'orgStudyIdInfo': {'id': 'ART-ASPI CATHETER-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'La Rochelle', 'country': 'France', 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arthesys', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}