Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT03129750
Status:
UNKNOWN
Last Update Posted:
2017-06-08
First Post:
2016-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-07', 'studyFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of instrumental restenosis', 'timeFrame': 'Post-Procedure', 'description': 'Rate of instrumental restenosis as determined by duplex ultrasound Peak Systolic Velocity Ratio (PSVR) \\> 2 post-index procedure evaluated by an independent core lab'}, {'measure': 'Procedural success rate', 'timeFrame': 'end of percutaneous procedure', 'description': 'Rate of procedural success in the absence of peri-procedural complications'}, {'measure': 'Walking capacity and quality of life', 'timeFrame': '6, 12, 24 and 36 months post-procedure', 'description': "walking capacity as assessed by walking impairment questionnaire (WIQ), and 6 minutes' walk test"}, {'measure': 'Rate of instrumental restenosis', 'timeFrame': '12, 24 and 36 months', 'description': 'Rate of instrumental restenosis as determined by duplex ultrasound Peak Systolic Velocity Ratio (PSVR) \\> 2 evaluated by an independent core lab'}, {'measure': 'Quality of Life', 'timeFrame': '6, 12, 24 and 36 months post-procedure', 'description': 'quality of life assessed by EQ5D questionnaire'}], 'primaryOutcomes': [{'measure': 'Rate of primary patency', 'timeFrame': '12 months after percutaneous treatment', 'description': 'Primary patency is defined as freedom from the combined endpoints of clinically-driven target lesion revascularization (TLR) and \\>50% restenosis in the treated lesion.'}], 'secondaryOutcomes': [{'measure': 'composite of all Major Adverse Events (MAE)', 'timeFrame': '24 months after percutaneous treatment', 'description': 'Incidence of the composite of all Major Adverse Events (MAE) through 24 months'}, {'measure': 'Incidence of Major Adverse Events (MAE)', 'timeFrame': '36 months after percutaneous treatment', 'description': 'Incidence of Major Adverse Events (MAE) through 36 months'}, {'measure': 'Clinical improvement as assessed by Rutherford Class changes', 'timeFrame': '6, 12, 24 and 36 months vs baseline', 'description': 'Clinical improvement as assessed by Rutherford Class changes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['PAD']}, 'descriptionModule': {'briefSummary': 'The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Coated Balloon (DCB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.\n\nThe present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DCB currently available on the market.', '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 DCB 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), 24 and 36 months (±30 days). Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Symptomatic patients with ischemic vascular disease presenting with TASC C and D.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Documented obstructive ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4\n2. Target lesion consists of a single solitary or multiple adjacent de novo or re-stenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm\n3. Target vessel is the superficial femoral artery and/or popliteal artery (P1-2-3)\n4. Life expectancy \\>1 year in the Investigator's opinion\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Patient unwilling or unlikely to comply with FU schedule\n2. Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure\n3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel\n4. Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure\n5. ≥15 cm long inflow lesion (≥50% DS)\n6. Failure to successfully treat \\< 15 cm long inflow lesion in the ipsilateral Iliac artery"}, 'identificationModule': {'nctId': 'NCT03129750', 'briefTitle': 'Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Ettore Sansavini Health Science Foundation'}, 'officialTitle': 'Safety and Efficacy of the Drug Coated Balloon (DCB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With TASC C and D Lesions: a Pilot Study', 'orgStudyIdInfo': {'id': 'ESREFO26'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Drug Coated Balloon', 'type': 'DEVICE', 'description': 'Peripheral PTA with a drug coated balloon'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83013', 'city': 'Mercogliano', 'state': 'Avellino', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angelo Cioppa, MD', 'role': 'CONTACT'}], 'facility': 'Casa di Cura Montevergine', 'geoPoint': {'lat': 40.92157, 'lon': 14.74491}}, {'zip': '16035', 'city': 'Rapallo', 'state': 'Genova', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'ICLAS', 'geoPoint': {'lat': 44.3496, 'lon': 9.22796}}, {'zip': '48033', 'city': 'Cotignola', 'state': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Micari, MD', 'role': 'CONTACT'}], 'facility': 'Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}, {'zip': '70124', 'city': 'Bari', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Roscitano, MD', 'role': 'CONTACT'}], 'facility': 'Santa Maria Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '95123', 'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pierfrancesco Veroux, MD, PhD', 'role': 'CONTACT'}], 'facility': 'A.O.U. Policlinico Vittorio Emanuele', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '73100', 'city': 'Lecce', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Armando Liso, MD', 'role': 'CONTACT'}], 'facility': 'Città di Lecce Hospital', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '80131', 'city': 'Napoli', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Esposito, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Policlinico Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '90135', 'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Vadalà, MD', 'role': 'CONTACT'}], 'facility': 'Maria Eleonora Hospital', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '00161', 'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabrizio Fanelli, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Policlinico Umberto I di Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10132', 'city': 'Torino', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Maria Pia Hospital', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'centralContacts': [{'name': 'Maria Salomone, MD', 'role': 'CONTACT', 'email': 'msalomone@esrefo.org', 'phone': '+390545217031'}, {'name': 'Maria Letizia Lunetto, D.Sc.PT', 'role': 'CONTACT', 'email': 'llunetto@ricercascientifica.org', 'phone': '+390545217032'}], 'overallOfficials': [{'name': 'Antonio Micari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maria Cecilia Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ettore Sansavini Health Science Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}