Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-29 @ 2:17 AM
Study NCT ID:
NCT01321866
Status:
TERMINATED
Last Update Posted:
2016-06-03
First Post:
2011-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}, {'id': 'D005402', 'term': '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': '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'Inclusion curve too slow.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-02', 'studyFirstSubmitDate': '2011-03-23', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary patency', 'timeFrame': '12 months', 'description': 'Primary patency following a first angioplasty of a first stenose in the affected zone.'}], 'secondaryOutcomes': [{'measure': 'Number of early re-stenoses', 'timeFrame': '3 months', 'description': 'stenosis defined as lumen diameter \\< 2mm'}, {'measure': 'Number of re-stenoses', 'timeFrame': '12 months', 'description': 'Stenosis defined as lumen diameter \\< 2mm'}, {'measure': 'Total days in hospital', 'timeFrame': '12 months', 'description': 'The total number of days hospitalized for stenosis, thrombosis, or recovering vascular access. This does not include regular hemodialysis activities.'}, {'measure': 'Number of stents used', 'timeFrame': '12 months', 'description': 'The total number of stents placed between the study angioplasty and the end-of-study visit.'}, {'measure': 'Total number of venous thromboses', 'timeFrame': '12 months', 'description': 'Total number of venous thromboses between study angioplasty and end-of-study visit'}, {'measure': 'Direct medical costs (€)', 'timeFrame': '12 months'}, {'measure': 'Indirect costs (€)', 'timeFrame': '12 months'}, {'measure': 'Questionnaire KDQOL', 'timeFrame': '12 months'}, {'measure': 'Questionnaire SF36', 'timeFrame': '12 months'}, {'measure': 'Questionnaire KDQOL', 'timeFrame': '3 months'}, {'measure': 'Questionnaire KDQOL', 'timeFrame': '6 months'}, {'measure': 'Questionnaire SF36', 'timeFrame': '3 months'}, {'measure': 'Questionnaire SF36', 'timeFrame': '6 months'}, {'measure': 'Fistula quality (cm*ml/min)', 'timeFrame': 'Baseline', 'description': 'cumulative length of "usable" fistula (cm) \\* venous flow during the last hemodialysis (ml/min)'}, {'measure': 'Fistula quality (cm*ml/min)', 'timeFrame': '6 months', 'description': 'cumulative length of "usable" fistula (cm) \\* venous flow during the last hemodialysis (ml/min)'}, {'measure': 'Fistula quality (cm*ml/min)', 'timeFrame': '12 months', 'description': 'cumulative length of "usable" fistula (cm) \\* venous flow during the last hemodialysis (ml/min)'}, {'measure': '% Stenosis', 'timeFrame': 'Baseline', 'description': '100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))\\*100)'}, {'measure': '% Stenosis', 'timeFrame': '6 months', 'description': '100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))\\*100)'}, {'measure': '% Stenosis', 'timeFrame': '12 months', 'description': '100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))\\*100)'}, {'measure': 'Presence/absence of complications associated with the angioplasty', 'timeFrame': 'Day of intervention'}, {'measure': '% Stenosis', 'timeFrame': '3 months', 'description': '100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))\\*100)'}, {'measure': 'Presence/absence of complications since the last visit', 'timeFrame': '6 months'}, {'measure': 'Presence/absence of complications since the last visit', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Angioplasty', 'cutting balloon'], 'conditions': ['Arteriovenous Fistula', 'Fistula']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 12 months of follow-up\n* The patient is on hemodialysis because of chronic renal insufficiency\n* The patient\'s vascular access is an arterio-venous fistula\n* The patient has a venous stenosis in the fistula (first event in the studied zone)\n* The patient is scheduled for angioplasty\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient cannot fluently read French\n* The patient cannot understand French\n* The patient is pregnant\n* The patient is breastfeeding\n* Short term dialysis\n* The vascular access is a "graft"\n* The stenosis in question is a recurrence, and not a first event in the studied zone\n* The life expectancy of the patient is \\< 12 months\n* Medical emergency situation\n* Peritoneal dialysis\n* At-home dialysis'}, 'identificationModule': {'nctId': 'NCT01321866', 'acronym': 'PREST', 'briefTitle': 'Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Randomized Trial Comparing a Cutting Balloon to a Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients', 'orgStudyIdInfo': {'id': 'AOI/2010/EP-01'}, 'secondaryIdInfos': [{'id': '2011-A00332-39', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon', 'interventionNames': ['Procedure: Cutting balloon angioplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard arm', 'description': 'Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon.', 'interventionNames': ['Procedure: Angioplasty']}], 'interventions': [{'name': 'Cutting balloon angioplasty', 'type': 'PROCEDURE', 'description': 'Angioplasty of fistula stenosis using a cutting balloon', 'armGroupLabels': ['Experimental arm']}, {'name': 'Angioplasty', 'type': 'PROCEDURE', 'description': 'Angioplasty of fistula stenosis using a non-cutting balloon', 'armGroupLabels': ['Standard arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Eric Picard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}