Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-01 @ 5:50 AM
Study NCT ID:
NCT04776434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2021-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 723}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically Driven Target Lesion Revascularization', 'timeFrame': '1 year after treatment', 'description': 'The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention.'}], 'secondaryOutcomes': [{'measure': 'Device Success', 'timeFrame': 'At end of procedure', 'description': 'Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure.'}, {'measure': 'Procedure success', 'timeFrame': 'At end of procedure', 'description': 'Device success and residual stenosis ≤50% at the end of the procedure.'}, {'measure': 'Clinical success', 'timeFrame': 'At discharge after procedure', 'description': 'Procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge.'}, {'measure': 'Major Adverse Limb Events (MALE) composite endpoint', 'timeFrame': 'At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months', 'description': 'Severe limb ischemia leading to an intervention or major vascular amputation (above the ankle).'}, {'measure': 'Major Cardiac Events Major Cardiac Events', 'timeFrame': 'At 1, 6, 12, 24, 36,48, 60 months', 'description': 'MI, Stroke, Cardiovascular death'}, {'measure': 'Death', 'timeFrame': 'At 1, 6, 12, 24, 36, 48, 60 months', 'description': 'All-cause, cardiac, device related, procedure related'}, {'measure': 'TLR', 'timeFrame': 'At 1, 6, 12, 24, 36, 48, 60 months', 'description': 'Number of Target Lesion Revascularizations'}, {'measure': 'TVR', 'timeFrame': 'At 1, 6, 12, 24, 36, 48, 60 months', 'description': 'Number of Target Vessel Revascularizations'}, {'measure': 'Time to first CD-TLR', 'timeFrame': 'up to 60 months', 'description': 'Time to first Clinically Driven Target Lesion Revascularization'}, {'measure': 'Target limb revascularization', 'timeFrame': 'At 1, 6, 12, 24, 36, 48, 60 months', 'description': 'Number of Target limb revascularizations'}, {'measure': 'Thrombosis at the target site', 'timeFrame': 'At 1 month', 'description': 'Number of Thrombosis at the target site'}, {'measure': 'Amputation', 'timeFrame': 'up to 60 months', 'description': 'Number of Amputations'}, {'measure': 'Rutherford Classification score', 'timeFrame': 'At 6, 12, 24, 36, 48, 60 months', 'description': 'Change in Rutherford Classification score from baseline (Scale from 0 to 6, higher score means worse outcome.'}, {'measure': 'Ankle Brachial Index (ABI)', 'timeFrame': 'At 6, 12 months only', 'description': 'Change in ankle brachial index (ABI) from baseline'}, {'measure': 'Pedal pulse', 'timeFrame': '6, 12 months only', 'description': 'Presence of Pedal pulse'}, {'measure': 'Wound status if applicable', 'timeFrame': '6, 12 months only', 'description': 'location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score'}, {'measure': 'Kawarada Classification score', 'timeFrame': 'At end of procedure', 'description': 'Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).', 'detailedDescription': 'Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).\n\nThis study will capture data from the use of the SELUTION SLR according to its approved labelling. Each indication for use will have a specific data sets in addition to generic data sets that are common across all indications.\n\nPatients will be followed for 5 years post-procedure to obtain safety and efficacy data. A health economic analysis will be made comparing data between countries within the study and to published data for existing treatment options. Generic and disease specific Patient Reported Outcome Measures (PROMs) will be used to measure the impact of the intervention on the overall health status of patients.\n\nImaging data collection for patients whose standard of care includes imaging follow-up will be captured and analysed.\n\nData will be collected from any subject who receives a CE marked device for treatment of a peripheral (i.e. non-cardiovascular) vascular lesion.\n\nData analysis will be stratified by lesion location.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject age is ≥ 18 years\n* Subject is able and willing to provide informed consent\n* Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use.\n\nExclusion Criteria:\n\n* In the opinion of the treating investigator the subject has a life expectancy of less than 12 months\n* In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime'}, 'identificationModule': {'nctId': 'NCT04776434', 'acronym': 'SUCCESS PTA', 'briefTitle': 'SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'M.A. Med Alliance S.A.'}, 'officialTitle': 'SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study', 'orgStudyIdInfo': {'id': 'S2020-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SELUTION SLR™ DEB', 'description': 'Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.', 'interventionNames': ['Device: SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)']}], 'interventions': [{'name': 'SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)', 'type': 'DEVICE', 'description': 'This study will capture data from the use of the SELUTION SLR according to its approved labelling.', 'armGroupLabels': ['SELUTION SLR™ DEB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Plata', 'country': 'Argentina', 'facility': 'Hospital Italiano La Plata', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Klinikum Hochsauerland', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'city': 'Buchholz', 'country': 'Germany', 'facility': 'Krankenhaus Buchholz', 'geoPoint': {'lat': 53.01126, 'lon': 9.56119}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Flensburg', 'country': 'Germany', 'facility': 'DIAKO Krankenhaus', 'geoPoint': {'lat': 54.78805, 'lon': 9.43722}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Medizinisches Versorgungszentrum', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Langensteinbach', 'country': 'Germany', 'facility': 'SRH Klinikum Karlsbad - Langensteinbach', 'geoPoint': {'lat': 49.04089, 'lon': 10.3116}}, {'city': 'München', 'country': 'Germany', 'facility': 'LMU Klinikum Campus Großhadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Weinheim', 'country': 'Germany', 'facility': 'Grn Klinik Weinheim', 'geoPoint': {'lat': 49.54887, 'lon': 8.66697}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Athens Medical Center', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Attikon University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Pátrai', 'country': 'Greece', 'facility': 'General University Hospital of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Elisabeth - TweeSteden Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital Singapore (NUHS)', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Trnava', 'country': 'Slovakia', 'facility': 'Trnava University Hospital', 'geoPoint': {'lat': 48.37773, 'lon': 17.58603}}, {'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires de Genève (HUG)', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'city': 'Frimley', 'country': 'United Kingdom', 'facility': 'Frimley Park Hospital', 'geoPoint': {'lat': 51.31667, 'lon': -0.74544}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospitals of Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust (ROYAL HOSPITAL LONDON)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's & St Thomas Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Redhill', 'country': 'United Kingdom', 'facility': 'East Surrey Hospital', 'geoPoint': {'lat': 51.24048, 'lon': -0.17044}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.A. Med Alliance S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}