Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05545267
Status:
UNKNOWN
Last Update Posted:
2022-09-19
First Post:
2022-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}], 'ancestors': [{'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-14', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morbidity and mortality', 'timeFrame': 'during intervention', 'description': 'The primary outcome measure to evaluate morbidity and mortality will be the number of acute complications that occurred during the procedure and by type of complication (wall hematoma, thrombosis, rupture, spasm, injection site hematoma, pseudoaneurysm, failure)'}], 'secondaryOutcomes': [{'measure': 'Post-angioplasty permeability', 'timeFrame': '2 years', 'description': 'Post-angioplasty primary permeability, and post-angioplasty primary assisted permeability and post-angioplasty secondary permeability over the entire follow-up period'}, {'measure': 'Stenosis diameter', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Variation of the stenosis diameter'}, {'measure': 'Endoluminal reference diameter', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Variation of the endoluminal diameter'}, {'measure': 'Maximum systolic velocity (VSmax)', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Variation of the maximum systolic velocity'}, {'measure': 'Ratio of VSmax to upstream', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Varation of Ratio of VSmax to upstream'}, {'measure': 'End-diastolic velocity', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Variation of end-diastolic velocity'}, {'measure': 'Diameter of the anastomosis', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Variation of anastomosis diameter'}, {'measure': 'Brachial artery Maximum flow', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Variation of brachial artery maximum flow'}, {'measure': 'Brachial artery end-diastolic velocity (EDV)', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Varaition of Brachial artery end-diastolic velocity'}, {'measure': 'Brachial artery maximum systolic velocity', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Variation of brachial artery maximum systolic velocity'}, {'measure': 'Brachial artery Resistance Index', 'timeFrame': 'pre-intervention, immediately after the intervention, 1 month', 'description': 'Variation of brachial artery Resistance Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood vessel repair', 'arteriovenous fistula', 'ultrasound angioplasty'], 'conditions': ['Arteriovenous Fistula Stenosis']}, 'descriptionModule': {'briefSummary': 'Dialysis vascular accesses called arteriovenous fistulas ( AVF) are essential to ensure extra-renal purification by hemodialysis for patients with chronic end-stage renal disease. Complications of dialysis AVF cause significant morbidity and hospitalization. Dialysis AVF angioplasties are frequently used to treat stenosis, the 1st complication concerning them and which announces the complete thrombosis which may be the definitive loss of the AVF. Historically performed under X-ray, the progression in the quality of ultrasound scanners allows today to perform this procedure under echo-Doppler guidance and thus to avoid both radiation and the injection of iodinated contrast products and their complications. It is thus possible to preserve residual renal function, a situation with a better prognosis, or to help the maturation of the AVF without precipitating the patient towards dialysis. The procedure can then be less costly, requiring a much lighter infrastructure.\n\nThe complication rates of ultrasound angioplasty remain poorly known because only a few series have been published. In addition, the evolution of the echo-Doppler parameters of the AVF is unknown during angioplasty and it is difficult to know which are the most reliable to distinguish during the procedure a "good angioplasty gesture" from an incomplete angioplasty to be continued. The proposed study would provide initial insight into the question posed.', 'detailedDescription': 'This is an observational, retrospective study on data from routine care. All angioplasties concerning major patients, meeting the inclusion criteria and performed during the inclusion period will be taken into account. (For this purpose, a list of procedures performed at the Vichy Hospital will be established via the angioplasty procedure reports.\n\nIn order to establish the evolution of the echographic parameters over time, the echographic data will also be collected from each follow-up report corresponding to each procedure until the end of the follow-up. These reports correspond to the normal post-intervention control ultrasounds at 1 month, 3 months and the annual visits. If intermediate ultrasounds are available, their reports will also be used.\n\nIn the case of a patient having an emergency angioplasty, the data of the control ultrasound triggering the intervention will be used as pre-intervention data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with end-stage renal disease treated by dialysis whose AVF angioplasties is performed under echo-doppler at the Vcihy Hospital Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Patient undergoing whose fistula is treated by angioplasty under echo-doplerat the Vichy Hospital Center between 01/01/2015 and 31/12/2019\n\nExclusion Criteria:\n\n* Patients who are minors,\n* Patients with an AVF with a flow rate \\< 100 mL/min.\n* Patients with acute or chronic, segmental or total occlusion of an AVF segment\n* Patients with acute or chronic, segmental or total thrombosis of an AVF segment\n* Patients whose main obstacle is located on the arterial side.\n* Intervention that required the use of X-rays.'}, 'identificationModule': {'nctId': 'NCT05545267', 'acronym': 'SAVE', 'briefTitle': 'Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Vichy'}, 'officialTitle': 'Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler (SAVE)', 'orgStudyIdInfo': {'id': 'SAVE1 - CHV 2018-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Angioplasties', 'type': 'PROCEDURE', 'otherNames': ['Angioplasties performed under echo-doppler'], 'description': 'Transluminal angioplastie'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03200', 'city': 'Vichy', 'country': 'France', 'facility': 'Centre Hospitalier de Vichy (CHV)', 'geoPoint': {'lat': 46.12709, 'lon': 3.42577}}], 'overallOfficials': [{'name': 'Fabrice ABBADIE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre hopsitalier de Vichy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Immediately following publication ending 5 years following arti', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal. Proposals should be directed to Fabrice.Abbadie@ch-vichy.fr'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Vichy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}