Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01247402
Status:
UNKNOWN
Last Update Posted:
2010-12-09
First Post:
2010-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paclitaxel Balloon Versus Standard Balloon in In-stent Restenoses of the Superficial Femoral Artery (PACUBA I Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-08', 'studyFirstSubmitDate': '2010-11-23', 'studyFirstSubmitQcDate': '2010-11-23', 'lastUpdatePostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary patency rate', 'timeFrame': '6 months', 'description': 'Primary patency at 6 month follow up, defined as \\<50%\\* diameter stenosis as demonstrated by CDUS and CTA in the absence of clinically driven TLR (Target Lesion Revascularization) during follow-up. Clinically driven TLR defined as reintervention of the target lesion due to presence of a symptomatic \\>50%\\* diameter stenosis.'}], 'secondaryOutcomes': [{'measure': 'severe adverse events', 'timeFrame': '30 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['peripheral arterial disease', 'in-stent restenosis', 'drug eluting balloon'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '27388828', 'type': 'DERIVED', 'citation': 'Kinstner CM, Lammer J, Willfort-Ehringer A, Matzek W, Gschwandtner M, Javor D, Funovics M, Schoder M, Koppensteiner R, Loewe C, Ristl R, Wolf F. Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery: 1-Year Results of the PACUBA Trial. JACC Cardiovasc Interv. 2016 Jul 11;9(13):1386-92. doi: 10.1016/j.jcin.2016.04.012.'}]}, 'descriptionModule': {'briefSummary': 'Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will be assigned to one of two study arms:\n\n1. Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA)\n2. Control Arm: standard percutaneous transluminal angioplasty (sPTA).\n\nPurpose:\n\nTo evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents compared to standard percutaneous transluminal angioplasty (sPTA).', 'detailedDescription': 'Introduction\n\nRestenosis after endovascular stenting with nitinol stents occurs in up to 30% of the patients at 12 months and up to 50% at 24 months. The rate of recurrence after repeated treatment of SFA in-stent restenoses ranges up to 70% at 6 months.\n\nA recent clinical trial suggested significant inhibition of re-restenosis after treatment of restenosis in coronary stents by Paclitaxel-coated angioplasty balloons.\n\nStudy Design\n\nProspective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will be assigned to one of two study arms:\n\n1. Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA)\n2. Control Arm: standard percutaneous transluminal angioplasty (sPTA).\n\nSubject Population:\n\nConsecutive subjects with symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will be screened and enrolled based on the study inclusion and exclusion criteria.\n\nObjectives:\n\nTo evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents compared to standard percutaneous transluminal angioplasty (sPTA).\n\nPrimary Endpoints:\n\nPrimary patency at 6 month follow up, defined as \\<50%\\* diameter stenosis as demonstrated by CDUS and CTA in the absence of clinically driven TLR (Target Lesion Revascularization) during follow-up. Clinically driven TLR defined as reintervention of the target lesion due to presence of a symptomatic \\>50%\\* diameter stenosis.\n\nSecondary Endpoints:\n\n1. Technical Success: achievement of a \\<30%\\* residual diameter stenosis by visual estimate.\n2. Clinical Success: improvement in clinical Rutherford-Becker category after the index procedure.\n3. Procedural Success: defined as Device Success without the occurrence of major adverse events (MAE) during the index hospitalization.\n4. MAE rate through 30 days post index procedure.\n5. Thrombotic occlusion of the Target Lesion at 30 days, 6 months, and 12 months post index procedure.\n6. Clinically driven Target Lesion Revascularization (TLR) at 6 months, and 12 months post index procedure.\n7. Binary Restenosis rate at 6 month and 12 month FU.\n\nFollow-Up Schedule:\n\nAll patients will be followed pre-study, 24 hours post-study, and follow-up evaluations at 30 days, 6 months, and 12 months after the Index procedure. Clinical evaluation and ankle brachial index (ABI) will be assessed pre-study, at 24 hours post-study, and at 6 months, and 12 months after the Index procedure. Colour Doppler ultrasound will be performed at 24 hours post-study, and at 6 months, and 12 months after the Index procedure. Computed tomography angiography (CTA) will be performed at 6 months after the Index procedure.\n\nStudy duration:\n\nThe enrolment period and follow-up study duration is projected for 24 months.\n\nSubject duration:\n\nEach subject is expected to be enrolled in the study for 12 months.\n\nInclusion Criteria:\n\nAll criteria 1-6 should apply for inclusion.\n\n1. Age \\> 50 years\n2. Patient legally authorized to provide written informed consent\n3. Patient willing and likely to comply with the follow up schedule\n4. Patient symptomatic Rutherford-Becker 2-5 (Fontaine II-IV)\n5. In-stent restenosis in the SFA and P1 segment of the popliteal artery (PA)\n6. Tibial run-off of at least 1 artery which however may be stenotic but amenable to PTA\n\nExclusion Criteria:\n\n1. Patients unable to give informed consent\n2. Patients enrolled in another study with any investigational drug or device\n3. Major surgical procedures (not including minor amputations) within 30 days prior to this study or planned within 30 days of entry into this study\n4. Pregnancy\n5. Patients with any known allergy, hypersensitivity or intolerance to radiologic contrast media, ASA, Clopidogrel or Ticlopidine, Paclitaxel\n6. Life expectancy of \\< 1 years\n\nBlood tests:\n\nTotal blood count, hematocrit, coagulation parameters, renal function parameters, fibrinogen and hsCRP will be taken before the Index procedure. At 6 months follow up creatinine, fibrinogen and hsCRP will be taken again.\n\nInterventions:\n\nInterventions will be performed percutaneously from an antegrade or an contralateral cross-over approach using 6 French sheaths. Biplane DSA including a ruler fixed at the patients thigh will be performed using two views at least 30° apart to evaluate lesion morphology, inflow disease and run-off. After successful wire passage through the target lesion, patients will be randomly assigned to either Paclitaxel eluting balloon angioplasty (PePTA) or standard percutaneous balloon angioplasty (sPTA) using computer generated random digits and sealed envelopes.\n\nMedical Therapy:\n\nAll patients receive aspirin 100mg daily indefinitely and clopidogrel 75 mg daily for 3 months post intervention. Aspirin and clopidogrel will be initiated at least 1 day prior to the intervention, otherwise a loading dose of 300 mg clopidogrel will be given during the intervention.\n\nControl CTA and CDUS:\n\nAngiographic evaluation of restenosis at 6 months will performed using contrast enhanced CTA. At colour Doppler ultrasound evaluation the wave form, peak systolic and diastolic velocity and the peak systolic velocity ration (PSV ratio) will be measured at 24 hours, 6 and 12 months post Index procedure. CDUS findings are consistent with significant restenosis (\\> 50%), as evidenced by PSV ratio \\> 2.5 within the treated arterial segment or occlusion of the treated arterial segment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll criteria 1-6 should apply for inclusion.\n\n1. Age \\> 50 years\n2. Patient legally authorized to provide written informed consent\n3. Patient willing and likely to comply with the follow up schedule\n4. Patient symptomatic Rutherford-Becker 2-5 (Fontaine II-IV)\n5. In-stent restenosis in the SFA and P1 segment of the popliteal artery (PA)\n6. Tibial run-off of at least 1 artery which however may be stenotic but amenable to PTA\n\nExclusion Criteria:\n\n1. Patients unable to give informed consent\n2. Patients enrolled in another study with any investigational drug or device\n3. Major surgical procedures (not including minor amputations) within 30 days prior to this study or planned within 30 days of entry into this study\n4. Pregnancy\n5. Patients with any known allergy, hypersensitivity or intolerance to radiologic contrast media, ASA, Clopidogrel or Ticlopidine, Paclitaxel\n6. Life expectancy of \\< 1 years'}, 'identificationModule': {'nctId': 'NCT01247402', 'acronym': 'PACUBA 1', 'briefTitle': 'Paclitaxel Balloon Versus Standard Balloon in In-stent Restenoses of the Superficial Femoral Artery (PACUBA I Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'A Monocenter Randomized Clinical Trial of PAClitaxel drUg-eluting BAlloon Versus Standard Percutaneous Transluminal Angioplasty to Reduce Restenosis in Patients With In-stent Stenoses in the Superficial Femoral and Proximal Popliteal Artery', 'orgStudyIdInfo': {'id': 'PACUBA 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel eluting balloon', 'description': 'Freeway 0.035 Paclitaxel eluting balloon (3 microgram Paclitaxel/mm2)', 'interventionNames': ['Device: drug eluting balloon angioplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard balloon angioplasty', 'description': 'standard balloon angioplasty', 'interventionNames': ['Device: standard balloon angioplasty']}], 'interventions': [{'name': 'drug eluting balloon angioplasty', 'type': 'DEVICE', 'otherNames': ['Freeway 0.035 balloon'], 'description': '3 microgram Paclitaxel/mm2 on balloon, 60s application', 'armGroupLabels': ['Paclitaxel eluting balloon']}, {'name': 'standard balloon angioplasty', 'type': 'DEVICE', 'description': 'standard balloon angioplasty', 'armGroupLabels': ['Standard balloon angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Renate Koppensteiner, MD', 'role': 'CONTACT', 'email': 'renate.koppensteiner@meduniwien.ac.at', 'phone': '+431 40400', 'phoneExt': '4671'}, {'name': 'Andrea Willfort-Ehringer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Gschwandtner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martin Schillinger, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Angiology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Johannes Lammer, MD', 'role': 'CONTACT', 'email': 'johannes.lammer@akhwien.at', 'phone': '+431 40400', 'phoneExt': '5802'}, {'name': 'Johanna Moyses', 'role': 'CONTACT', 'email': 'johanna.moyses@akhwien.at', 'phone': '+431 40400', 'phoneExt': '6742'}, {'name': 'Renate Koppensteiner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria Schoder, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrea Willfort-Ehringer MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Gschwandtner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martin Funovics, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christian Loewe, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Florian Wolf, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christina Plank, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wolfgang Matzek, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cardiovascular and Interventional Radiology, AKH-MUW', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Johannes Lammer, MD', 'role': 'CONTACT', 'email': 'johannes.lammer@akhwien.at', 'phone': '+431 40400', 'phoneExt': '5802'}, {'name': 'Johanna Moyses', 'role': 'CONTACT', 'email': 'johanna.moyses@akhwien.at', 'phone': '+431 40400', 'phoneExt': '6742'}], 'overallOfficials': [{'name': 'Johannes Lammer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Univerity Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Johannes Lammer MD, Professor of Radiology', 'oldOrganization': 'Department of Radiology, Cardiovascular and Interventional Radiology'}}}}