Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06056193
Status:
WITHDRAWN
Last Update Posted:
2025-06-29
First Post:
2023-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The SIR-POBA Bypass Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564658', 'term': 'Peripheral Arterial Occlusive Disease 1'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000800', 'term': 'Angioplasty, Balloon'}], 'ancestors': [{'id': 'D017130', 'term': 'Angioplasty'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Limited recruiting', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Primary Lesion Target Patency of the venous bypass stenosis', 'timeFrame': '2 years', 'description': 'The incidence of patency will be analysed after reopening the stenosis of the venous bypass.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autologous Vein Bypass', 'Endovascular Revascularization'], 'conditions': ['Peripheral Arterial Occlusive Disease', 'Bypass Complication', 'Femoropopliteal Artery Occlusion', 'Femoropopliteal Stenosis', 'Critical Limb-Threatening Ischemia', 'Claudication, Intermittent']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment options.', 'detailedDescription': 'This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options (plain old ballon angioplasty versus sirolimus coated balloon angioplasty). The recruitment phase is calculated for two years with a planned follow-up of 2 years. Follow-up data will be collected to answer the endpoints and will include all available follow-ups to monitor the bypass up to 2 years after the procedure. Typically, follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age at least 18 years\n* Informed consent with signature\n* Rutherford category 2 or 3 (in terms of lifestyle-limiting moderate or severe claudication symptomatology) or chronic critical ischemia (Rutherford 4-6)\n* Venous bypass stenosis requiring intervention\n* Confirmed inflow\n* At least 1 crural outflow vessel\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Active infection or sepsis\n* Patients currently participating in another clinical trial\n* Unconfirmed inflow\n* Intolerance to sirolimus\n* Coagulopathy\n* Radiotherapy\n* Patients on immunosuppressive therapy\n* Non-dialysis renal insufficiency (eGFR \\< 45 ml/min/1.73m2)\n* Use of potent CYP3A4 and/or P-gp inhibitors (such as ketoconazole, Voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong CYP3A4 and/or P-gp inducers (such as rifampin or rifabutin).'}, 'identificationModule': {'nctId': 'NCT06056193', 'briefTitle': 'The SIR-POBA Bypass Trial', 'organization': {'class': 'OTHER', 'fullName': 'Paracelsus Medical University'}, 'officialTitle': 'SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass Trial', 'orgStudyIdInfo': {'id': '1036/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plain Balloon Angioplasty', 'description': 'Plain Balloon Angioplasty will be used to treat lesions', 'interventionNames': ['Procedure: Balloon Angioplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus-coated Balloon Angioplasty', 'description': 'Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty', 'interventionNames': ['Procedure: Balloon Angioplasty']}], 'interventions': [{'name': 'Balloon Angioplasty', 'type': 'PROCEDURE', 'otherNames': ['Endovascular Revascularization'], 'description': 'Revascularisation procedures will be performed according to randomised list', 'armGroupLabels': ['Plain Balloon Angioplasty', 'Sirolimus-coated Balloon Angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'country': 'Austria', 'facility': 'University Hospital of Salzburg, Paracelsus Medical University', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'overallOfficials': [{'name': 'Manuela Pilz, MD PD FEBVS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Physician'}, {'name': 'Klaus Linni, MD PD FEBVS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of Division of Vascular and Endovascular Surgery'}, {'name': 'Stephanie Rassam, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Resident Physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paracelsus Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MedAlliance Swiss Medical Technology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Physician', 'investigatorFullName': 'Manuela Pilz', 'investigatorAffiliation': 'Paracelsus Medical University'}}}}