Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT03452293
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2018-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost-efficiency analysis', 'timeFrame': '12 months', 'description': 'Cost-efficiency analysis based on the comparison of the yearly procedural related costs and hospital stay(s) between patients treated with the SUPERSUB strategy, vs a propensity-matched historical cohort of patients with the same type of lesions (TASC C-D), treated by PTA alone, after subintimal crossing.'}, {'measure': 'Cost-efficiency analysis', 'timeFrame': '24 months', 'description': 'Cost-efficiency analysis based on the comparison of the yearly procedural related costs and hospital stay(s) between patients treated with the SUPERSUB strategy, vs a propensity-matched historical cohort of patients with the same type of lesions (TASC C-D), treated by PTA alone, after subintimal crossing.'}, {'measure': 'Technical success', 'timeFrame': '1 month', 'description': 'Technical success defined as achievement of a final in-lesion residual diameter stenosis of ≤30% as determined by the angiographic core lab'}, {'measure': 'Clinical success', 'timeFrame': '1 month', 'description': 'Clinical success defined as technical success without the occurrence of major adverse events'}, {'measure': 'Procedural success', 'timeFrame': '1 month', 'description': 'Procedural success defined as lesion success without the occurrence of major adverse events'}, {'measure': 'ABI index or transcutaneous oxymetry (TcPO2) improvement', 'timeFrame': '6 and 12 months vs baseline', 'description': 'Improve in the ABI index or transcutaneous oxymetry (TcPO2)'}], 'primaryOutcomes': [{'measure': 'Primary Patency Rate', 'timeFrame': '24 months', 'description': 'Primary Patency is defined as freedom from clinically driven TLR (CD-TLR) defined as repeat percutaneous intervention or surgical bypass graft to treat an angiographic significant restenosis (\\>50%) at the level of the treated lesion ±10 mm (proximally and/or distally)'}], 'secondaryOutcomes': [{'measure': 'Freedom from Restenosis', 'timeFrame': '12 months', 'description': 'Freedom from restenosis (diameter stenosis \\> 50%, determined by peak systolic velocity ratio (PSVR) \\>2.4 by duplex ultrasonography)'}, {'measure': 'Freedom from Restenosis', 'timeFrame': '24 months', 'description': 'Freedom from restenosis (diameter stenosis \\> 50%, determined by peak systolic velocity ratio (PSVR) \\>2.4 by duplex ultrasonography)'}, {'measure': 'Composite of All Major Adverse Events', 'timeFrame': '12 Months', 'description': 'Incidence of the composite of all Major Adverse Events'}, {'measure': 'Composite of All Major Adverse Events', 'timeFrame': '24 Months', 'description': 'Incidence of the composite of all Major Adverse Events'}, {'measure': 'Incidence of Major Adverse Events', 'timeFrame': '12 months', 'description': 'Incidence of Major Adverse Events'}, {'measure': 'Incidence of Major Adverse Events', 'timeFrame': '24 months', 'description': 'Incidence of Major Adverse Events'}, {'measure': 'Stent integrity assessment', 'timeFrame': '12 months', 'description': 'Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images'}, {'measure': 'Stent integrity assessment', 'timeFrame': '24 months', 'description': 'Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images'}, {'measure': 'Primary Sustained Clinical Improvement', 'timeFrame': '6,12 and 24 months vs baseline', 'description': 'Clinical Improvement as assessed by Rutherford Class changes'}, {'measure': 'Quality of Life (EQ-5D-5L Questionnaire)', 'timeFrame': '6 months', 'description': 'Quality of Life improvement as assessed by EQ-5D-5L Questionnaire Parameters \\[Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression\\] Values \\[(1) No Problems, (2) Slight Problems, (3) Moderate Problems, (4) Severe Problems, (5) Unable to\\] Value \\[1 - Best score, Value 5 - Worse Score\\]'}, {'measure': 'Quality of Life improvement (SF12 Questionnaire)', 'timeFrame': '6 months', 'description': 'Quality of Life improvement as assessed by SF12 Questionnaire Parameters \\[Overall Health, Physical health, Role and Physical health, Role and Mental health, Mental health\\] Values for Overall Health \\[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\\] Values for Role and Physical health \\[ 1-Very limiting, 2-Partially limiting, 3-Not limiting\\] Values for Physical health \\[ 1-yes, 2-no\\], \\[1- best score\\] , \\[2-worse score\\] Values for Role and Mental health \\[ 1-yes, 2-no\\], \\[1- best score\\] , \\[2-worse score\\] Values for Mental Health \\[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\\]'}, {'measure': 'Quality of Life (EQ-5D-5L Questionnaire)', 'timeFrame': '12 months', 'description': 'Quality of Life improvement as assessed by EQ-5D-5L Questionnaire Parameters \\[Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression\\] Values \\[(1) No Problems, (2) Slight Problems, (3) Moderate Problems, (4) Severe Problems, (5) Unable to\\] Value 1 - Best score, Value 5 - Worse Score'}, {'measure': 'Quality of Life improvement (SF12 Questionnaire)', 'timeFrame': '12 months', 'description': 'Quality of Life improvement as assessed by SF12 Questionnaire Parameters \\[Overall Health, Physical health, Role and Physical health, Role and Mental health, Mental health\\] Values for Overall Health \\[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\\] Values for Role and Physical health \\[ 1-Very limiting, 2-Partially limiting, 3-Not limiting\\] Values for Physical health \\[ 1-yes, 2-no\\], \\[1- best score\\] , \\[2-worse score\\] Values for Role and Mental health \\[ 1-yes, 2-no\\], \\[1- best score\\] , \\[2-worse score\\] Values for Mental Health \\[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\\]'}, {'measure': 'Quality of Life (EQ-5D-5L Questionnaire)', 'timeFrame': '24 months', 'description': 'Quality of Life improvement as assessed by EQ-5D-5L Questionnaire Parameters \\[Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression\\] Values \\[(1) No Problems, (2) Slight Problems, (3) Moderate Problems, (4) Severe Problems, (5) Unable to\\] Value 1 - Best score, Value 5 - Worse Score'}, {'measure': 'Quality of Life improvement', 'timeFrame': '24 months', 'description': 'Quality of Life improvement as assessed by SF12 Questionnaire Parameters \\[Overall Health, Physical health, Role and Physical health, Role and Mental health, Mental health\\] Values for Overall Health \\[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\\] Values for Role and Physical health \\[ 1-Very limiting, 2-Partially limiting, 3-Not limiting\\] Values for Physical health \\[ 1-yes, 2-no\\], \\[1- best score\\] , \\[2-worse score\\] Values for Role and Mental health \\[ 1-yes, 2-no\\], \\[1- best score\\] , \\[2-worse score\\] Values for Mental Health \\[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\\]'}, {'measure': 'Amputation Rates', 'timeFrame': '1 month', 'description': 'Major and Minor amputations'}, {'measure': 'Amputation Rates', 'timeFrame': '6 months', 'description': 'Major and Minor amputations'}, {'measure': 'Amputation Rates', 'timeFrame': '12 months', 'description': 'Major and Minor amputations'}, {'measure': 'Amputation Rates', 'timeFrame': '24 months', 'description': 'Major and Minor amputations'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PAD']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our conclusions and therefore establish the generalizability of this strategy.', 'detailedDescription': 'The present study is designed as a prospective, open label, observational study.\n\nThe study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.\n\nPatients elected for endovascular revascularization with SuperSub strategy will be asked their written consent to the use of their personal data.\n\nRevascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days) and 24 months (±30 days). Angiographic follow-up will be performed only in symptomatic patients, as clinically indicated and with the aim for a new treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by lower extremities artery disease and referred for the endovascular treatment of de novo or re-stenotic lesions (no in stent restenosis) in the femoro-popliteal arteries.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral Inclusion Criteria:\n\n* Patients with CLI and TASC C-D Fem-Pop CTO\'s\n* Age ≥18 years\n* Patient has signed an approved consent form\n* Patients without previous stenting of the Fem-Pop segment\n\nAngiographic Inclusion Criteria:\n\n* Patent and hemodynamically normal iliac and common femoral arteries.\n* At least one patent and healthy tibial vessel runoff to the foot.\n* Patient has documented TASC C or D Fem-Pop CTO\'s prior to the study procedure\n* Rutherford Category 4, 5 or 6\n* Subintimal crossing of the occluded Fem-Pop vessels\n* Supera Stenting From healthy to healthy arterial segment.\n\nExclusion Criteria:\n\n* Patient unwilling or unlikely to comply with Follow-Up schedule\n* Endoluminal crossing of the CTO\n* Inability to stent from "healthy to healthy" arterial segments.\n* Inability to re-enter within the pre-specified Ideal Landing Zone (IDL)'}, 'identificationModule': {'nctId': 'NCT03452293', 'acronym': 'SUPERSUBII', 'briefTitle': 'SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients', 'organization': {'class': 'OTHER', 'fullName': 'EndoCore Lab s.r.l.'}, 'officialTitle': 'SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients', 'orgStudyIdInfo': {'id': 'EndoCore01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stent Peripheral System', 'type': 'DEVICE', 'description': 'Peripheral PTA with Supera Stent implantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49519', 'city': 'Wyoming', 'state': 'Michigan', 'country': 'United States', 'facility': 'Metro Health Hospital', 'geoPoint': {'lat': 42.91336, 'lon': -85.70531}}, {'zip': 'S2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '67051', 'city': 'Avezzano', 'state': 'AQ', 'country': 'Italy', 'facility': 'Ospedale di Avezzano', 'geoPoint': {'lat': 42.02896, 'lon': 13.42641}}, {'zip': '81024', 'city': 'Maddaloni', 'state': 'CE', 'country': 'Italy', 'facility': 'Clinica San Michele', 'geoPoint': {'lat': 41.03578, 'lon': 14.3823}}, {'zip': '95123', 'city': 'Catania', 'state': 'CT', 'country': 'Italy', 'facility': 'A.O.U. Policlinico Vittorio Emanuele', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '73039', 'city': 'Tricase', 'state': 'LE', 'country': 'Italy', 'facility': 'A.O. Cardinale Panico', 'geoPoint': {'lat': 39.93018, 'lon': 18.35421}}, {'zip': '35031', 'city': 'Abano Terme', 'state': 'Padova', 'country': 'Italy', 'facility': 'Casa di Cura Abano Terme', 'geoPoint': {'lat': 45.35753, 'lon': 11.78725}}, {'zip': '06129', 'city': 'Perugia', 'state': 'PG', 'country': 'Italy', 'facility': 'A.O.U. Santa Maria della Misericordia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '00133', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Policlinico Tor Vergata', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00184', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'A.O. San Giovanni Addolorata', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '07100', 'city': 'Sassari', 'state': 'SS', 'country': 'Italy', 'facility': 'A.O.U. di Sassari', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'zip': '91016', 'city': 'Erice', 'state': 'TP', 'country': 'Italy', 'facility': 'Ospedale San Antonio Abate', 'geoPoint': {'lat': 38.03785, 'lon': 12.58778}}, {'zip': '05100', 'city': 'Terni', 'state': 'TR', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Santa Maria di Terni', 'geoPoint': {'lat': 42.56335, 'lon': 12.64329}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'AORN Antonio Cardarelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': 'HA1 3UJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'London North West HealthCare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Maria Salomone, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EndoCore Lab'}, {'name': 'Mariano L Palena, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Casa di Cura Abano Terme'}, {'name': 'Larry J Diaz, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Metro Health Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EndoCore Lab s.r.l.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Italiana Vascolare', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}