Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-27 @ 5:45 PM
Study NCT ID:
NCT03365492
Status:
COMPLETED
Last Update Posted:
2020-07-01
First Post:
2017-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioFreedom Pharmacokinetic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], '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'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Commercially available BioFreedomTM (stainless steel BA9TM drug-coated stent)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus', 'timeFrame': 'Measured upto 72 hours after stent implantation', 'description': 'To characterize the maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus'}, {'measure': 'To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus', 'timeFrame': 'Measured upto 72 hours after stent implantation', 'description': 'To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The purpose of this pharmacokinetic (PK) study is to characterize the maximum concentration (Cmax) and time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (CAD) patients following implantation of BioFreedomTM SS stent.', 'detailedDescription': 'The purpose of this pharmacokinetic (PK) study is to characterize the maximum concentration (Cmax) and time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (CAD) patients following implantation of BioFreedomTM SS stent.\n\nThe study will include up to 20 CAD patients following implantation of the commercially available BioFreedomTM SS stent in a single Spanish center. Venous blood samples will be taken up to 72 hours after implantation. Whole blood concentrations of Biolimus A9TM and its active metabolites sirolimus and everolimus will be determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay. Mean, median and range of PK variables (Cmax, Tmax, and AUC) together with a Summary Statistics table will be generated as part of the PK analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction;\n3. Presence of one or more coronary artery stenoses \\>50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or more stents;\n4. Patient receives one or more BioFreedom stents resulting in a total stent length ranging from 30mm to 45mm;\n\nExclusion Criteria:\n\n1. Individual is pregnant, nursing or planning to be pregnant;\n2. Patient presents with STEMI;\n3. Known intolerance to aspirin, clopidogrel, heparin, zinc, stainless steel, Biolimus A9TM or contrast material;\n4. Inability to provide informed consent;\n5. Currently participating in another trial;\n6. Treatment with any DES within the previous 6 months;\n7. Patient requires a stent \\<2.25mm;\n8. Patient requires a stent \\>4.0mm;\n9. Patient receives a non-study DES stent during the index procedure;\n10. Use of a drug coated balloon planned at the index procedure;\n11. Systemic use of a -limus drug.'}, 'identificationModule': {'nctId': 'NCT03365492', 'briefTitle': 'BioFreedom Pharmacokinetic Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosensors Europe SA'}, 'officialTitle': 'BioFreedom PK Study in Patients With CAD Who Receive the BioFreedom™ Biolimus A9™ Stent', 'orgStudyIdInfo': {'id': '17EU03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Patients with CAD who receive the BioFreedom™ Biolimus A9™ stent.', 'interventionNames': ['Device: BioFreedom™ BA9™ drug-coated stent']}], 'interventions': [{'name': 'BioFreedom™ BA9™ drug-coated stent', 'type': 'DEVICE', 'description': 'Drug-coated stent for coronary arteries', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosensors Europe SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}