Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT03686358
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2018-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint at 3 years', 'timeFrame': 'The inclusion day', 'description': 'Composite endpoint at 3 years :\n\n* Cardiovascular or renal mortality,\n* Initiation of a renal replacement therapy or estimated glomerular filtration rate decrease of more than 50%, Cardiovascular morbidity: hospitalization for congestive heart failure, myocardial infarction, myocardium, stroke.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Angioplasty on Atherosclerotic Stenosis']}, 'descriptionModule': {'briefSummary': 'The interest of renal angioplasty in the nosological framework of atherosclerotic stenosis has been significantly challenged by STAR and ASTRAL clinical trials in 2009, confirmed by the CORAL study in 2014.\n\nThese studies did not show any benefit of the gesture on renal function, morbidity and cardiovascular mortality or the tension control. The aim of the study is to evaluate renal angioplasty on atherosclerotic stenosis.', 'detailedDescription': 'Previous studies did not concern the indication of renal angioplasty in some high-risk situations, such as malignant or resistant renal vascular hypertension, OAP (Acute pulmonary oedema) flash or acute renal failure of ischemic origin.\n\nThere is no work in the literature that has studied retrospectively the evolution of angioplasty practices renal artery disease on atherosclerotic stenosis since 2009, nor their remote results of the gesture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having undergone renal arterial angioplasty on atherosclerotic stenosis between 01/01/2010 and 12/31/2013 at Rennes University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OAP flash: hospitalization for Acute congestive heart failure without any other identified etiology than renal artery stenosis\n* Resistant arterial hypertension under treatment including a diuretic\n* Acute renal failure or ischemic renal failure quickly progressive\n* Radiological criteria: renal ischemia visualized at arterial time of angio-CT or renal angio-MRI\n\nExclusion Criteria:\n\n* Renal transplant patients\n* Patients with another etiology of secondary hypertension, including fibro-muscular dysplasia of renal artery\n* Restenosis on stent, angioplasty of accessory renal artery\n* Patients subject to legal protection (safeguard of justice, guardianship) and persons deprived of liberty\n* Patients objecting to participate to the study'}, 'identificationModule': {'nctId': 'NCT03686358', 'acronym': 'PARAS', 'briefTitle': 'Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010', 'orgStudyIdInfo': {'id': '35RC17_3069'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Renal artery angioplasty', 'type': 'PROCEDURE', 'description': 'Patients meeting the inclusion criteria were selected from the medical records of renal angioplasty performed at the Rennes University Hospital between 01/01/2010 and 12/31/2013. Each selected patient will receive a notice by mail of information. In the absence of opposition from them within a two weeks, the processing of their data will begin :\n\n* Evaluation of the results at 3 years of renal angioplasty on atherosclerotic stenosis performed at Rennes University Hospital\n* Evaluation of indications of renal angioplasty on stenosis atherosclerosis performed after 2009 at Rennes University Hospital\n* Identification of prognostic factors'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'state': 'Brittany Region', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Thierry FROUGET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rennes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}