Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 3:06 PM
Study NCT ID:
NCT06082466
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2023-10-09', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of primary patency of the venous bypass', 'timeFrame': '2 years', 'description': 'The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass.'}], 'secondaryOutcomes': [{'measure': 'Incidence of procedure-related mortality', 'timeFrame': '2 years', 'description': 'Mortality intervention-related'}, {'measure': 'Incidence of 30-day mortality', 'timeFrame': '30 days', 'description': 'Number of participants, who die within 30 days after the procedure.'}, {'measure': 'Incidence of limb salvage after procedure', 'timeFrame': '2 years', 'description': 'Amputation free survival'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extraluminal Bypass Stenting', 'Autologous Vein Graft', 'Bypass Extremity Graft'], 'conditions': ['Peripheral Arterial Occlusive Disease', 'Femoropopliteal Artery Occlusion', 'Femoropopliteal Stenosis', 'Critical Limb-Threatening Ischemia', 'Claudication, Intermittent']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.', 'detailedDescription': 'Patients presenting to Vascular Surgical Units are usually multimorbid with increased cardiopulmonary risk. Autologous venous bypass is indicated in certain situations despite the longer duration of surgery. Optimizing patency has been an important goal since many years. Reconstruction problems are often based on intimal hyperplasia, which can be reduced via covering of the harvested vein as seen in previous studies.\n\nThis 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, which are a plain venous conduit or a by mesh covered venous conduit. During this clinical trial, the first follow-up will take place after 6 weeks; this corresponds to the usual follow-up interval. Due to the trial, further follow-ups will take place for each of the patients after 3 months, 6 months, 12 months, 2 years.'}, '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 form with signature\n* Rutherford Category 3 (\\<200m) or chronic critical ischemia (Rutherford Category 4-6)\n* Assured inflow and recipient artery.\n\nExclusion Criteria\n\n* Pregnant or breastfeeding women\n* Active infection or sepsis\n* Acute ischemia\n* Endovascular procedure in the region to be treated.\n* Vein with outer diameter \\<3.5 mm or \\>8 mm under pressure.\n* Spliced Veins.\n* Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum).\n* Vasculitis\n* Coagulopathy\n* Radiation therapy near the anastomosis'}, 'identificationModule': {'nctId': 'NCT06082466', 'acronym': 'Framed IVB', 'briefTitle': 'FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial', 'organization': {'class': 'OTHER', 'fullName': 'Paracelsus Medical University'}, 'officialTitle': 'FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial', 'orgStudyIdInfo': {'id': '1144/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Autologous Bypass', 'interventionNames': ['Procedure: Conventional Autologous Bypass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FRAMED Infrainguinal Venous Bypass', 'interventionNames': ['Procedure: FRAMED Infrainguinal Venous Bypass']}], 'interventions': [{'name': 'FRAMED Infrainguinal Venous Bypass', 'type': 'PROCEDURE', 'description': 'The harvested vein graft will be covered with a mesh.', 'armGroupLabels': ['FRAMED Infrainguinal Venous Bypass']}, {'name': 'Conventional Autologous Bypass', 'type': 'PROCEDURE', 'description': 'The harvested vein graft will be used without a mesh coating.', 'armGroupLabels': ['Conventional Autologous Bypass']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Klaus Linni, MD PD', 'role': 'CONTACT', 'email': 'k.linni@salk.at'}], 'facility': 'University Hospital of Salzburg, Paracelsus Medical University', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'centralContacts': [{'name': 'Stephanie Rassam, MD', 'role': 'CONTACT', 'email': 's.rassam@salk.at', 'phone': '+43 572550 57506'}, {'name': 'Stephan Koter, MD, PD', 'role': 'CONTACT', 'email': 's.koter@salk.at', 'phone': '+43 572550 55677'}], 'overallOfficials': [{'name': 'Stephan Koter, MD, PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Physician'}, {'name': 'Stephanie Rassam, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Resident Physician'}, {'name': 'Klaus Linni, MD, PD, FEBVS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paracelsus Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Division of Vascular and Endovascular Surgery, MD PD', 'investigatorFullName': 'Klaus Linni', 'investigatorAffiliation': 'Paracelsus Medical University'}}}}