Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT03388892
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Eluting Balloon in Arteriovenous Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Paclitaxel-coated balloon safety', 'timeFrame': '1 year', 'description': 'Record complications of paclitaxel-coated balloon such as graft failure and vessel dissection or rupture.'}], 'primaryOutcomes': [{'measure': 'patent rate in percentage after PTA', 'timeFrame': '1 year', 'description': 'Late luminal loss in patients was evaluated by quantitative angiography after PTA and intravascular ultrasound (IVUS) up to 12 months after PTA. Late luminal loss is defined as the difference between the minimal lumen diameter in percentage and the late luminal loss less than 50% was defined as patency.'}], 'secondaryOutcomes': [{'measure': 'The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)', 'timeFrame': '1 year', 'description': 'Measure the stenotic percentage every 2 months up to 1 year for angiography'}, {'measure': 'The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)', 'timeFrame': '1 year', 'description': 'Measure the stenotic percentage 1, 6, 12 months for IVUS'}, {'measure': 'Change of AVG flow in liter per minute', 'timeFrame': '1 year', 'description': 'measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA'}, {'measure': 'Change of AVG pressure in mmHg', 'timeFrame': '1 year', 'description': 'measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA'}, {'measure': 'Time interval of patent AVG after PTA', 'timeFrame': '1 year', 'description': 'Patent AVG was defined as luminal loss less than 50%'}, {'measure': 'The rate of AVG failure at 6 months and 12 months', 'timeFrame': '1 year', 'description': 'AVG failure was defined as AVG thrombosis, AVG re-intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Angioplasty', 'Drug Eluting Balloon', 'Arteriovenous Graft'], 'conditions': ['Kidney Failure, Chronic', 'Angioplasty', 'Dialysis']}, 'referencesModule': {'references': [{'pmid': '31611105', 'type': 'DERIVED', 'citation': 'Liao MT, Lee CP, Lin TT, Jong CB, Chen TY, Lin L, Hsieh MY, Lin MS, Chie WC, Wu CC. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg. 2020 Jun;71(6):1994-2003. doi: 10.1016/j.jvs.2019.07.090. Epub 2019 Oct 11.'}]}, 'descriptionModule': {'briefSummary': "The investigators' study aims is to evaluate the safety and efficacy of percutaneous transluminal angioplasty (PTA) with paclitaxel-coated balloon (PCB) at venous anastomotic stenosis of arteriovenous graft (AVG) in patients with hemodialysis"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 to 90 years\n2. Patients under hemodialysis via prosthetic arteriovenous graft in the arm\n3. Vascular access was created for more than 30 days and used at least one successful session\n4. Clinical failure for hemodialysis due to higher venous pressure or lower arterial flow\n5. Angiography proved venous anastomotic stenosis ≥50% (the entire lesion of venous anastomotic stenosis will be extended into AVG no more than 2cm and naive vein no more than 7 cm). There was no other obvious stenosis.\n6. Reference diameter of venous anastomosis within 7 mm\n\nExclusion Criteria:\n\n1. Patient could not write informed consent\n2. Being unwilling or unable to return for follow-up visits or reason to believe that adherence to follow-up visits would be irregular\n3. Current or scheduled enrollment in other, conflicting studies.\n4. Acute thrombosis in the past 3 months\n5. Central venous stenosis\n6. Concomitant disease (e.g., terminal cancer) or other medical condition likely to result in death within 6 months\n7. A blood coagulation disorder\n8. Sepsis or infected arteriovenous access graft\n9. A contraindication to the use of contrast medium\n10. Pregnancy'}, 'identificationModule': {'nctId': 'NCT03388892', 'briefTitle': 'Drug-Eluting Balloon in Arteriovenous Graft', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital Hsin-Chu Branch'}, 'officialTitle': 'A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft', 'orgStudyIdInfo': {'id': '103-065-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug-Eluting Balloon', 'description': 'PTA with DEB at venous anastomotic stenosis of AVG', 'interventionNames': ['Device: paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plain Balloon', 'description': 'PTA with PCB at venous anastomotic stenosis of AVG', 'interventionNames': ['Device: Plain Balloon']}], 'interventions': [{'name': 'paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)', 'type': 'DEVICE', 'description': "Arteriovenous graft (AVG) dysfunction or acute thrombosis is mainly caused by neointimal hyperplasia. Although endovascular intervention, such as percutaneous transluminal angioplasty (PTA), catheter-based directed thrombolysis with urokinase, mechanical thrombectomy with percutaneous thrombolytic device or even if graft stenting, can salvage the hemodialysis access, the long-term primary and secondary patent rate don't improve due to repeated restenosis from neointimal hyperplasia. Drug eluting balloon is used in reducing neointimal hypoplasia in patients with coronary in-stent restenosis and it's also effective in restenosis of peripheral arterial diseases. It's reasonable to hypothesize that PTA with PCB at venous anastomotic stenosis of AVG could prolong the patency and reduce the acute thrombosis rate.", 'armGroupLabels': ['Drug-Eluting Balloon']}, {'name': 'Plain Balloon', 'type': 'DEVICE', 'description': 'Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention', 'armGroupLabels': ['Plain Balloon']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hsinchu', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Hsinchu Branch', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital Hsin-Chu Branch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}