Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 5:22 AM
Study NCT ID:
NCT06173960
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-22'}], 'estimatedResultsFirstSubmitDate': '2025-12-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017073', 'term': 'Atherectomy'}], 'ancestors': [{'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the long-term clinical effects (after 3 years of follow-up) of Jetstream atherectomy combined with Ranger - Target Lesion Revascularization', 'timeFrame': 'From the date of the procedure until the date of the Target Lesion Revascularization, assessed up to 3 years', 'description': 'Estimation of median time between the procedure and the Target Lesion Revascularization'}, {'measure': 'Evaluation of the long-term clinical effects (after 3 years of follow-up) of Jetstream atherectomy combined with Ranger - Lesions number and proportion', 'timeFrame': '3 years after the procedure', 'description': 'Number and proportion of lesions with absence of Target Lesion Revascularization at 3-year follow-up after the surgery'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the 3-year clinical outcome of Jetstream atherectomy combined with Ranger, without reoperation, in patients with calcified femoropopliteal lesions', 'timeFrame': '3 years following the procedure', 'description': 'Clinical outcome at 3 years will be assessed by the number and proportion of patients with a reduction in Rutherford category ≥1, or stable at 1 for patients with Rutherford category =1 at inclusion, compared with the baseline value before surgery and without re-intervention'}, {'measure': 'Evaluation of the procedural success of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions - stenosis', 'timeFrame': 'During the procedure', 'description': 'The procedural success of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with presence of stenosis of residual diameter \\<30%'}, {'measure': 'Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - dissection', 'timeFrame': 'During the procedure', 'description': 'The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with absence of dissection'}, {'measure': 'Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - ruptured vessels', 'timeFrame': 'During the procedure', 'description': 'The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with presence of ruptured vessels'}, {'measure': 'Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - distal embolisation', 'timeFrame': 'During the procedure', 'description': 'The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with presence of distal embolisation'}, {'measure': 'Evaluation of the success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions - arteriovenous fistula', 'timeFrame': 'During the procedure', 'description': 'The success of the Jetstream atherectomy device combined with Ranger in patients with calcified femoropopliteal lesions will be assessed at the time of the procedure by the number and proportion of patients with presence of arteriovenous (AV) fistula'}, {'measure': 'Assessing the primary patency of Jetstream atherectomy combined with Ranger in patients with calcified femoropopliteal lesions', 'timeFrame': 'At 12 months and 36 months', 'description': 'Primary patency assessed by echo-Doppler'}, {'measure': 'Description of the atherectomy procedure in patients with calcified femoropopliteal lesions - bailout', 'timeFrame': 'During the procedure', 'description': 'Atherectomy procedure described by the number and type of additional stents (bailout) implanted'}, {'measure': 'Description of the atherectomy procedure in patients with calcified femoropopliteal lesions - paclitaxel eluting balloons', 'timeFrame': 'During the procedure', 'description': 'Atherectomy procedure described by the number of paclitaxel eluting balloons, Ranger (Drug Coat Balloons, DCB), used'}, {'measure': 'Check that there is no revascularisation of clinical origin after the surgery - Target Lesion Revascularization', 'timeFrame': 'At 1, 6, 12 and 24 months post-procedure', 'description': 'The absence of revascularisation after the surgery will be verified by the number and proportion of patients with clinically-induced Target Lesion Revascularization'}, {'measure': 'Check that there is no revascularisation of clinical origin after the surgery - Target Vessel Revascularization', 'timeFrame': 'At 1, 6, 12, 24 and 36 months post-procedure', 'description': 'The absence of revascularisation after the surgery will be verified by the number and proportion of patients with clinically-induced Target Vessel Revascularization'}, {'measure': 'Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Rutherford category', 'timeFrame': 'At 1, 6, 12, 24 and 36 months post-procedure', 'description': 'The 3-year clinical follow-up will be described by the number and proportion of patients with an improvement in the Rutherford category (reduction \\<1) compared with the reference value before surgery'}, {'measure': 'Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Systolic Pressure Index', 'timeFrame': 'At 1, 6, 12, 24 and 36 months post-procedure', 'description': 'The 3-year clinical follow-up will be described by the number and proportion of patients with an improvement in Systolic Pressure Index (SPI) (increase ≥0.10) compared with the baseline value before surgery'}, {'measure': 'Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Deaths', 'timeFrame': '3 years following the procedure', 'description': 'The 3-year clinical follow-up will be described by the number and proportion of total deaths and number and proportion of cardiovascular deaths'}, {'measure': 'Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Amputations', 'timeFrame': 'At 1, 6, 12, 24 and 36 months post-procedure', 'description': 'The 3-year clinical follow-up will be described by the number and proportion of patients with major amputations'}, {'measure': 'Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - MACE', 'timeFrame': 'At 1, 6, 12, 24 and 36 months post-procedure', 'description': 'The 3-year clinical follow-up will be described by the number and proportion of patients with a major cardiovascular event (MACE)'}, {'measure': 'Description of the 3-year clinical follow-up of patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions - Repeat surgery', 'timeFrame': '3 years following the procedure', 'description': 'The 3-year clinical follow-up will be described by the number and proportion of patients who had a repeat surgery and the total number of repeat surgeries (by cutaneous or bypass route)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Femoropopliteal Lesions'], 'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this non interventional study is to evaluate the long-term clinical effects (3-year follow-up after the procedure) of Jetstream atherectomy combined with a paclitaxel-eluting balloon (Ranger) in all patients who were treated for calcified femoropopliteal lesions (de novo, single or multiple, mono- or bilateral) between December 1, 2016 and December 31, 2020 at the Clinique Rhône-Durance, Avignon, France', 'detailedDescription': 'This study is a non-interventional, retrospective, descriptive, single-centre study of adult male and female patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions, in order to assess the long-term clinical effects of this treatment.\n\nThe study will be conducted at the Clinique Rhône-Durance. Data on the management of all adult patients with calcified femoropopliteal lesions treated with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020 will be collected and recorded for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients treated for femoropopliteal lesions (de novo, single or multiple, mono or bilateral) by Jetstream atherectomy in combination with a Ranger paclitaxel-eluting balloon (Drug Coated Balloon (DCB)) between December 1st, 2016 and December 31st, 2020 at the Rhône-Durance Clinic in Avignon, France, will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* treated for femoropopliteal lesions with Jetstream atherectomy in combination with a Ranger paclitaxel-eluting balloon (Drug Coated Balloon (DCB)) between 1 December 2016 and 31 December 2020.\n* Informed and not opposed to the use of their data in this study.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT06173960', 'acronym': 'FIDJI', 'briefTitle': '3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions', 'organization': {'class': 'OTHER', 'fullName': "Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique"}, 'officialTitle': '3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions', 'orgStudyIdInfo': {'id': 'FIDJI-2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with calcified femoropopliteal lesions', 'description': 'Patients presenting calcified femoropopliteal lesions (de novo, unique or multiple, mono or bilateral) and treated by atherectomy with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020', 'interventionNames': ['Device: atherectomy']}], 'interventions': [{'name': 'atherectomy', 'type': 'DEVICE', 'description': 'Jetstream atherectomy in combination with Ranger paclitaxel elution balloon (Drug Coated Balloon (DCB))', 'armGroupLabels': ['Patients with calcified femoropopliteal lesions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': 'Clinique Rhône-Durance', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}], 'overallOfficials': [{'name': 'Jérôme BRUNET, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Rhône-Durance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}