Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-01 @ 1:58 PM
Study NCT ID:
NCT01593059
Status:
TERMINATED
Last Update Posted:
2014-04-28
First Post:
2012-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIOFLOW-III Romania Satellite Registry
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'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-25', 'studyFirstSubmitDate': '2012-05-04', 'studyFirstSubmitQcDate': '2012-05-04', 'lastUpdatePostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': '12 months', 'description': 'Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': '6 and 18 months'}, {'measure': 'Target Vessel Revascularization (TVR)', 'timeFrame': '6, 12 and 18 months', 'description': 'Any repeat revascularization of the target vessel.'}, {'measure': 'Target Lesion Revascularization (TLR)', 'timeFrame': '6, 12 and 18 months', 'description': 'Any repeat revascularization of the target lesion.'}, {'measure': 'Stent Thrombosis', 'timeFrame': '6, 12 and 18 months'}, {'measure': 'Clinical Device Success', 'timeFrame': 'At time of intervention'}, {'measure': 'Clinical Procedural Success', 'timeFrame': 'During the hospital stay to a maximum of the first seven days post index procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['International', 'Multicenter', 'Observational registry', 'Orsiro Drug Eluting Stent (DES)', 'Stenting', 'Treatment of Coronary Artery Disease', 'Coronary revascularization', 'Percutaneous Coronary Intervention', 'STEMI', 'NSTEMI', 'Ischemia', 'Angina', 'Subgroups', 'Acute Myocardial Infarction', 'Diabetes', 'Small Vessels', 'Chronic Total Occlusion (CTO)'], 'conditions': ['Coronary Artery Disease', 'Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': 'This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).', 'detailedDescription': 'For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences.\n\nBare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures.\n\nThe invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration.\n\nThese advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic coronary artery disease\n* Subject has signed informed consent for data release\n* Subject is geographically stable and willing to participate at all follow-up assessments\n* Subject is ≥ 18 years\n* Elective PCI with DES\n\nExclusion Criteria:\n\n* Subject did not sign informed consent for data release\n* Pregnancy\n* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media\n* Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained\n* Currently participating in another study and primary endpoint is not reached yet.'}, 'identificationModule': {'nctId': 'NCT01593059', 'briefTitle': 'BIOFLOW-III Romania Satellite Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik Vertriebs-GmbH'}, 'officialTitle': 'BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Romania', 'orgStudyIdInfo': {'id': 'G1106'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Orsiro DES'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucharest', 'country': 'Romania', 'facility': 'Cardiovascular Diseases Institute CC Iliescu', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'University Hospital Bucharest', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'County Emergency Hospital', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '540136', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Country Hospital', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}], 'overallOfficials': [{'name': 'Dragos Vinereanu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bucharest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik Vertriebs-GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}