Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-31 @ 7:30 PM
Study NCT ID:
NCT05952206
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2023-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028145', 'term': "2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine"}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking:\n\n* Open-label for the stent type\n* Open-label for the antiplatelet regimen'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Phase III, prospective, randomized (1:1:1:1), factorial design 2x2, active control, and multicentre clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2312}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To determine the rate of Patient-Oriented Composite endpoint', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of individual components of All cause, cardiovascular, and cardiac death', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of recurrent myocardial infarction', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of target lesion revascularization', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of target vessel revascularization', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of stent thrombosis', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of clinical device success', 'timeFrame': 'Immediatly after the procedure'}, {'measure': 'To determine the rate of clinical procedural success', 'timeFrame': 'Immediatly after the procedure'}, {'measure': 'To determine the rate of bleeding events', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of net adverse clinical endpoints (NACE)', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of major adverse cardiac and cerebral events (MACCE)', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of transfusion rates', 'timeFrame': '1-2-3-4-5 years'}, {'measure': 'To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study', 'timeFrame': '1 year'}, {'measure': 'To determine the rate of adverse ischemic events at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'To determine the rate of target lesion failure between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group.', 'timeFrame': '1 year'}, {'measure': 'To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) between an abbreviated DAPT regimen and the standard of care DAPT (tested for superiority of the experimental arm).', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To determine the rate of adverse ischemic events between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy (tested for non-inferiority).', 'timeFrame': '1 year'}, {'measure': 'Rate of target lesion failure between angiolite stent and Xience stent family (Skypoint or Sierra) (tested for non-inferiority) in the standard of care subgroup.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['angiolite', 'dual antiplatelet therapy', 'percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Immediately after the first randomization, the study compares (second randomization) the superiority in bleeding Bleeding Academic Research Consortium (BARC) 2, 3, or 5 of abbreviated DAPT versus standard of care. Both primary endpoints will be evaluated at 12 months of follow-up. The study will be open-label for the stent type and the antiplatelet regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 - \\< 95 years;\n* Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length);\n* Able to provide informed consent and willing to participate in the trial.\n\nExclusion Criteria:\n\n* Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.;\n* Known severe hepatic impairment Child-Pug stage C;\n* Prior PCI (not related to the study) performed in the last 45 days;\n* Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;\n* Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI;\n* Active major bleeding or major surgery within the last 30 days;\n* Known stroke (any type) within the 30 days prior to the randomization;\n* Women of childbearing potential being defined as woman from the onset of menstruation (menarche) until they become postmenopausal, unless they are permanently sterile. A postmenopausal state is clarified as having no menstrual periods for 12 consecutive months without any other medical cause. Women who have undergone permanent sterilization methods, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, can be enrolled in the study\n* Currently participating in another randomized controlled trial and not yet at its primary endpoint;\n* Life expectancy less than one year due to non-cardiovascular comorbidity.'}, 'identificationModule': {'nctId': 'NCT05952206', 'acronym': 'ANGIODAPT', 'briefTitle': 'Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'iVascular S.L.U.'}, 'officialTitle': 'Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy. A 2x2 Factorial, All-comer, Multicenter, Randomized Controlled Trial: ANGIODAPT', 'orgStudyIdInfo': {'id': 'ANGIODAPT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Angiolite and abbreviated DAPT', 'description': 'Acute coronary syndrome patients:\n\n* Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6 months.\n* No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1M. Only the same P2Y12 inhibitor up to 12M.\n\nChronic coronary syndrome patients:\n\n* Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.\n* No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.', 'interventionNames': ['Device: Angiolite: Sirolimus-eluting stent', 'Drug: 1-month DAPT']}, {'type': 'EXPERIMENTAL', 'label': 'Xience stent family and abbreviated DAPT', 'description': 'Acute coronary syndrome patients:\n\n* Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.\n* No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Only the same P2Y12 inhibitor up to 12M.\n\nChronic coronary syndrome patients:\n\n* Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.\n* No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.', 'interventionNames': ['Device: Xience: Everolimus-eluting stent', 'Drug: 1-month DAPT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Angiolite and standard of care DAPT', 'description': 'Acute coronary syndrome patients:\n\n* Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.\n* No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M.\n\nChronic coronary syndrome:\n\n* Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.\n* No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid.', 'interventionNames': ['Device: Angiolite: Sirolimus-eluting stent', 'Drug: 12-month DAPT (Standard of care)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xience stent family and standard of care DAPT', 'description': 'Acute coronary syndrome patients:\n\n* Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.\n* No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M.\n\nChronic coronary syndrome:\n\n* Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.\n* No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid.', 'interventionNames': ['Device: Xience: Everolimus-eluting stent', 'Drug: 12-month DAPT (Standard of care)']}], 'interventions': [{'name': 'Angiolite: Sirolimus-eluting stent', 'type': 'DEVICE', 'otherNames': ['iVascular angiolite'], 'description': 'The angiolite stent (iVascular, Barcelona, Spain) is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design containing a durable biostable coating composed of three layers - acrylate to ensure adhesion to the metal surface, fluoroacrylate that carries the sirolimus, and a top layer of fluoroacrylate to control drug release.', 'armGroupLabels': ['Angiolite and abbreviated DAPT', 'Angiolite and standard of care DAPT']}, {'name': 'Xience: Everolimus-eluting stent', 'type': 'DEVICE', 'otherNames': ['Xience stent family'], 'description': 'The Xience stent family (Abbott vascular, California, United States of America), characterized by an L-605 cobalt-chromium (CoCr) is a thin-strut cobalt-chromium everolimus-eluting stent with an open-cell design containing a nonerodable polymer made of PBMA, a reservoir made of a fluorinated copolymer of vinylidene fluoride and hexafluoropropylene monomers. Xience™ stent family includes XIENCE Skypoint™ and XIENCE Sierra™', 'armGroupLabels': ['Xience stent family and abbreviated DAPT', 'Xience stent family and standard of care DAPT']}, {'name': '1-month DAPT', 'type': 'DRUG', 'description': 'DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Then, only the same oral P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor) up to 12 months.\n\nThe type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC', 'armGroupLabels': ['Angiolite and abbreviated DAPT', 'Xience stent family and abbreviated DAPT']}, {'name': '12-month DAPT (Standard of care)', 'type': 'DRUG', 'description': 'DAPT with acetylsalicylic acid and prasugrel or ticagrelor up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC', 'armGroupLabels': ['Angiolite and standard of care DAPT', 'Xience stent family and standard of care DAPT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Collet', 'role': 'CONTACT'}], 'facility': 'Olv Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Bonheiden', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Dewilde', 'role': 'CONTACT'}], 'facility': 'IMELDA', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Charleroi', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Mohamed Ben Yedder', 'role': 'CONTACT'}], 'facility': 'CHU Marie Curie', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'city': 'Genk', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Cottens', 'role': 'CONTACT'}], 'facility': 'ZOL GENK', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Pieter-Jan Palmers', 'role': 'CONTACT'}], 'facility': 'CHC Montlégia', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Saad', 'role': 'CONTACT'}], 'facility': 'Hospital de La Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Mons', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Carlier', 'role': 'CONTACT'}], 'facility': 'Chu Ambroise Pare', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'city': 'Roeselare', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Vanhaverbeke', 'role': 'CONTACT'}], 'facility': 'Az Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Turnhout', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Herman Van der Stighelen', 'role': 'CONTACT'}], 'facility': 'Az Turnhout', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr. VAN BELLE', 'role': 'CONTACT'}], 'facility': 'Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Massy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr. Garot', 'role': 'CONTACT'}], 'facility': 'Icps Massy', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'city': 'Quincy-sous-Sénart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr. UNTERSEEH', 'role': 'CONTACT'}], 'facility': 'Ipcs Quincy', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'DR. LHERMUSIER', 'role': 'CONTACT'}], 'facility': 'Chu Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'A Coruña', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ramon Calviño', 'role': 'CONTACT'}], 'facility': 'Complejo Hospitalario Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Almería', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ricardo Fajardo', 'role': 'CONTACT'}], 'facility': 'Complejo Hospitalario Torrecárdenas', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Salvatore Brugaleta', 'role': 'CONTACT'}], 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Dabit Arzamendi', 'role': 'CONTACT'}], 'facility': 'Hospital de La Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Xavier Carrillo', 'role': 'CONTACT'}], 'facility': 'Hospital Germans Trias I Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan Antoni Gomez', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Bruno García', 'role': 'CONTACT'}], 'facility': "Hospital Universitario Vall D'Hebrón", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cáceres', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Fernandez Portales', 'role': 'CONTACT'}], 'facility': 'Hospital San Pedro de Alcantara', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'city': 'Huelva', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio Gómez Menchero', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Jerez de la Frontera', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio Agarrado', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Jerez de La Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'city': 'Las Palmas de Gran Canaria', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro Martín', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de Gran Canaria Doctor Negrín', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'city': 'León', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Armando Pérez de Prado', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando Sarnago', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Antonio Fernández Díaz', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristóbal Urbano', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Regional de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Horacio Alonso Briales', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen de La Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eduardo Pinar', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico Universitario Virgen de La Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Palma de Mallorca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vicente Peral', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Valeriano Ruiz', 'role': 'CONTACT'}], 'facility': 'Hospital de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Santander', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose María De la Torre', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Santiago de Compostela', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ramiro Trillo', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Sanchis', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Luis Díez Gil', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Y Politécnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ignacio Amat', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Vigo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Andrés Iñíguez', 'role': 'CONTACT'}], 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria del Rosario Ortas', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Sara Pich, PhD', 'role': 'CONTACT', 'email': 'spich@ivascular.global', 'phone': '+34 936 724 711'}, {'name': 'Andrea Mancera', 'role': 'CONTACT', 'email': 'amancera@bcccbarcelona.cat', 'phone': '+34645093750'}], 'overallOfficials': [{'name': 'Manel Sabaté', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iVascular S.L.U.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}