Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT05788432
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2023-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sequent Extended Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-26', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)', 'timeFrame': '12 months', 'description': 'Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'Freedom from MACE in the subgroup of Lesions In-stent Restenosis', 'timeFrame': '12 months', 'description': 'Freedom from MACE in the subgroup of Lesions In-stent Restenosis'}, {'measure': 'Freedom from MACE in the subgroup of Native vessel lesions', 'timeFrame': '12 months', 'description': 'Freedom from MACE in the subgroup of Native vessel lesions'}, {'measure': 'Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches', 'timeFrame': '12 months', 'description': 'Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches'}, {'measure': 'Procedural success', 'timeFrame': 'Immediately after PCI (Percutaneous Coronary Intervention)', 'description': 'Procedural success ( Residual stenosis \\<30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDR (Medical Device Regulations)', 'PMCF (Post-Market Clinical Follow-up)', 'Paclitaxel eluting coronary balloon dilatation catheter'], 'conditions': ['Coronary Artery Disease', 'Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '31204115', 'type': 'BACKGROUND', 'citation': 'Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13.'}, {'pmid': '30170854', 'type': 'BACKGROUND', 'citation': 'Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.'}, {'pmid': '26139054', 'type': 'BACKGROUND', 'citation': 'Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Benedicto A, Masotti M, Zueco J, Iniguez A, Velazquez M, Moreno R, Mainar V, Dominguez A, Pomar F, Melgares R, Rivero F, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS IV Study Investigators (under auspices of Interventional Cardiology Working Group of Spanish Society of Cardiology). A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial. J Am Coll Cardiol. 2015 Jul 7;66(1):23-33. doi: 10.1016/j.jacc.2015.04.063.'}, {'pmid': '17101615', 'type': 'BACKGROUND', 'citation': 'Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.'}, {'pmid': '20052480', 'type': 'BACKGROUND', 'citation': 'Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010 Mar;99(3):165-74. doi: 10.1007/s00392-009-0101-6. Epub 2010 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.', 'detailedDescription': 'The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device Regulation requirements for post-market clinical follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Sequent Please Neo according to routine hospital practice and following instructions for use.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.\n* Informed Consent Signed.\n\nExclusion Criteria:\n\n* Patient life expectancy less than 12 months.\n* Contraindication for antiplatelet therapy.\n* Not meet inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05788432', 'acronym': 'rEpic06', 'briefTitle': 'Sequent Extended Study', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'Sequent Please Neo Extended Post-Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'rEpic06- SEQUENT EXTENDED'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Disease (CAD)', 'interventionNames': ['Device: Sequent Please Neo']}], 'interventions': [{'name': 'Sequent Please Neo', 'type': 'DEVICE', 'description': 'Patients in whom treatment with (Sequent Please Neo) has been attempted', 'armGroupLabels': ['Coronary Artery Disease (CAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Alava', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Araba', 'geoPoint': {'lat': 43.36057, 'lon': -6.19946}}, {'zip': '03010', 'city': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante Dr.Balmis', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '06080', 'city': 'Badajoz', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Badajoz', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08916', 'city': 'Badalona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias I Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '48903', 'city': 'Barakaldo', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '08025', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de La Santa Creu Y Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '11009', 'city': 'Cadiz', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta Del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '12004', 'city': 'Castelló', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitari de Castelló', 'geoPoint': {'lat': 41.01149, 'lon': 0.84856}}, {'zip': '10003', 'city': 'Cáceres', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario San Pedro de Alcantara', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '13005', 'city': 'Ciudad Real', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Ciudad Real', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'zip': '03203', 'city': 'Elche', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '33394', 'city': 'Gijón', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Cabueñes', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'zip': '17007', 'city': 'Girona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitari Dr. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '21005', 'city': 'Huelva', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Juan Ramon Jimenez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '23007', 'city': 'Jaén', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Jaen', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '240801', 'city': 'León', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Leon', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '27003', 'city': 'Lugo', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Lucus Agusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28006', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de La Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '06800', 'city': 'Mérida', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de Mérida', 'geoPoint': {'lat': 38.91802, 'lon': -6.34292}}, {'zip': '37007', 'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '41013', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '45007', 'city': 'Toledo', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitario de Toledo', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'centralContacts': [{'name': 'ORIOL RODRIGUEZ LEOR, MD, PhD', 'role': 'CONTACT', 'email': 'oriolrodriguez@gmail.com', 'phone': '0034934651200'}, {'name': 'FUNDACION EPIC', 'role': 'CONTACT', 'email': 'iepic@fundacionepic.org', 'phone': '0034987876135'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}