Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-02-22 @ 3:50 PM
Study NCT ID:
NCT02843633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-02-03
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LEADERS FREE II: BioFreedom™ Pivotal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-08-30', 'mcpReleaseN': 22, 'releaseDate': '2021-08-03'}, {'resetDate': '2021-10-08', 'mcpReleaseN': 23, 'releaseDate': '2021-09-14'}], 'estimatedResultsFirstSubmitDate': '2021-08-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000800', 'term': 'Angioplasty, Balloon'}, {'id': 'D010975', 'term': 'Platelet Aggregation Inhibitors'}], 'ancestors': [{'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1203}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2020-01-13', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-07-21', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The composite of cardiac death and myocardial infarction at twelve months', 'timeFrame': '12 months'}, {'measure': 'The incidence of clinically driven target lesion revascularization at twelve months', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'The composite of cardiac death and myocardial infarction', 'timeFrame': '1, 2, and 6 months and 2 and 3 years'}, {'measure': 'The incidence of clinically driven target lesion revascularization', 'timeFrame': '1, 2, and 6 months and 2 and 3 years'}, {'measure': 'The composite of cardiac death, myocardial infarction and stent thrombosis', 'timeFrame': '1, 2, and 6 months and 1, 2, and 3 years'}, {'measure': 'Bleeding per Bleeding Academic Research Consortium (BARC) Criteria', 'timeFrame': '1, 2, and 6 months and 1, 2, and 3 years'}, {'measure': 'Cardiac Death', 'timeFrame': '1, 2, and 6 months and 1, 2, and 3 years'}, {'measure': 'Myocardial Infarction', 'timeFrame': '1, 2, and 6 months and 1, 2, and 3 years'}, {'measure': 'Stent Thrombosis per Academic Research Consortium (ARC) Definition', 'timeFrame': '1, 2, and 6 months and 1, 2, and 3 years'}, {'measure': 'Urgent target lesion revascularization', 'timeFrame': '1, 2, and 6 months and 1, 2, and 3 years'}, {'measure': 'Clinically driven target lesion revascularization at time points other than primary endpoint', 'timeFrame': 'followed for all target lesion revascularizations, up to 3 years'}, {'measure': 'Clinically driven target vessel revascularization', 'timeFrame': '1, 2, and 6 months and 1, 2, and 3 years'}, {'measure': 'All cause mortality', 'timeFrame': '1, 2, and 6 months and 1, 2, and 3 years'}, {'measure': 'Primary endpoints, in patients with at least 1 lesion treated with a trial stent of 3mm or less in nominal diameter', 'timeFrame': '1, 2, and 6 months and 1, 2, and 3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Acute Coronary Syndrome', 'Percutaneous Coronary Intervention', 'Drug Coated Stent', 'Drug Eluting Stent'], 'conditions': ['Acute Coronary Syndrome', 'High Bleeding Risk']}, 'referencesModule': {'references': [{'pmid': '38890129', 'type': 'DERIVED', 'citation': 'Eberli FR, Oldroyd KG, Urban P, Krucoff MW, Morice MC, Tanguay JF, Leon MB, Brunel P, Maillard L, Lipiecki J, Cook S, Berland J, Hovasse T, Carrie D, Schutte D, Sadozai Slama S, Garot P. Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years. Open Heart. 2024 Jun 18;11(1):e002679. doi: 10.1136/openhrt-2024-002679.'}, {'pmid': '38626080', 'type': 'DERIVED', 'citation': 'Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.'}, {'pmid': '32432718', 'type': 'DERIVED', 'citation': 'Mehran R, Chandrasekhar J, Urban P, Lang IM, Windhoevel U, Spaulding C, Copt S, Stoll HP, Morice MC; LEADERS FREE Investigators. Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial. JAMA Cardiol. 2020 Aug 1;5(8):939-947. doi: 10.1001/jamacardio.2020.0285.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.', 'detailedDescription': 'In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAny indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.\n\nReasons of unsuitability for \\> 1 month dual antiplatelet treatment must include one or more of the following:\n\n1. Adjunctive oral anticoagulation treatment planned to continue after PCI\n2. Age ≥ 75 years old\n3. Baseline Hgb \\<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)\n4. Any prior intracerebral bleed\n5. Any stroke in the last 12 months\n6. Hospital admission for bleeding during the prior 12 months\n7. Non skin cancer diagnosed or treated \\< 3 years, with a perceived increased risk for bleeding\n8. Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for \\>30 days after PCI\n9. Planned surgery that would require interruption of DAPT (within next 6 months)\n10. Renal failure defined as: Creatinine clearance \\<40 ml/min\n11. Thrombocytopenia (PLT \\<100,000/mm3)\n12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice\n13. Expected non-compliance to prolonged DAPT for other medical reasons\n\nExclusion Criteria:\n\n1. Pregnant and breastfeeding women\n2. Patients expected not to comply with 1 month DAPT\n3. Patients requiring a planned staged PCI procedure more than one week after the index procedure\n4. Procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy\n5. Active bleeding at the time of inclusion\n6. Reference vessel diameter \\<2.25 - \\>4.0mm\n7. Cardiogenic shock\n8. Compliance with long-term single anti-platelet therapy unlikely\n9. A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated\n10. PCI during the previous 12 months for a lesion other than the target lesion of the index procedure\n11. Participation in another clinical trial (12 months after index procedure)\n12. Patients with a life expectancy of \\< 12 months\n13. Patients under judicial protection, tutorship or curatorship (for France only)'}, 'identificationModule': {'nctId': 'NCT02843633', 'briefTitle': 'LEADERS FREE II: BioFreedom™ Pivotal Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosensors Europe SA'}, 'officialTitle': 'A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding', 'orgStudyIdInfo': {'id': '16US01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioFreedom™ Drug Coated Stent', 'interventionNames': ['Device: BioFreedom™ Drug Coated Coronary Stent System', 'Drug: Antiplatelet Drug']}], 'interventions': [{'name': 'BioFreedom™ Drug Coated Coronary Stent System', 'type': 'DEVICE', 'otherNames': ['Coronary Angioplasty'], 'description': 'a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis', 'armGroupLabels': ['BioFreedom™ Drug Coated Stent']}, {'name': 'Antiplatelet Drug', 'type': 'DRUG', 'description': 'Dual antiplatelet therapy for one month followed by single antiplatelet therapy indefinitely. Aspirin and clopidogrel (or other P2Y12 inhibitor) will be used and dosing is according to standard institutional practice', 'armGroupLabels': ['BioFreedom™ Drug Coated Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research, LLC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '71901', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Tri-Lakes Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Health', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '93102', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Cottage Hospital', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Velella Research', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Research Institute, Inc.', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'North Georgia Heart Foundation', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St. Luke's Idaho Cardiology Associates", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Jesse Brown VA Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Heart Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Jewish and St. Mary's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48708', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Bay Region', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '48670', 'city': 'Midland', 'state': 'Michigan', 'country': 'United States', 'facility': 'MidMichigan Medical Center Midland', 'geoPoint': {'lat': 43.61558, 'lon': -84.24721}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Cardiovascular Specialists, LLP', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College-New York Presbyterian', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center/New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Heart and Vascular Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'LeBauer Cardiovascular Research Foundation', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NC Heart and Vascular Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '43701', 'city': 'Zanesville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Genesis Healthcare System', 'geoPoint': {'lat': 39.94035, 'lon': -82.01319}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State - Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19610', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Berks Cardiologists, Ltd.', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'zip': '17043', 'city': 'Wormleysburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health Cardiovascular Institute', 'geoPoint': {'lat': 40.26287, 'lon': -76.91386}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'AnMed Health', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Black Hills Cardiovascular Research', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Heart Institute', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37934', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennova Healthcare-Turkey Creek Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Providence Health Center', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Clinic', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Mazankowski Alberta Heart Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3L 3W4', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Fraser Clinical Trials Inc.', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': 'V6E 1M7', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 4R2', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Victoria Heart Institute Foundation', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Maisonneuve-Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut universitaire de cardiologie et de pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '13097', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Clinique Axium', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '63050', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Service de Cardiologie Interventionnelle - Pôle Santé République', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21121', 'city': 'Fontaine-lès-Dijon', 'country': 'France', 'facility': 'Clinique de Fontaine', 'geoPoint': {'lat': 47.34238, 'lon': 5.02007}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Groupe Hospitalier Mutualiste de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '91300', 'city': 'Massy', 'country': 'France', 'facility': 'Hôpital Privé Jacques Cartier ICPS', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '91480', 'city': 'Quincy-sous-Sénart', 'country': 'France', 'facility': 'Hôpital Privé Claude Galien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Clinique Saint Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse Rangeuil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Segeberger Kliniken GmbH', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00152', 'city': 'Rome', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Camillo Forlanini', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital, Dorset Heart Centre', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BT63 5QQ', 'city': 'Craigavon', 'country': 'United Kingdom', 'facility': 'Craigavon Cardiac Centre', 'geoPoint': {'lat': 54.44709, 'lon': -6.387}}, {'zip': 'G81 4DY', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Martin Leon', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiovascular Research Foundation, New York'}, {'name': 'Mitchell Krucoff', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Philip Urban', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital de la Tour'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The emphasis in all scientific publications and presentations will be placed on the 1-year endpoint'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosensors Europe SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}