Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-21 @ 9:04 AM
Study NCT ID:
NCT02817802
Status:
UNKNOWN
Last Update Posted:
2023-02-10
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Latvia']}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2066}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)* at 12 months', 'timeFrame': '12 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Registry', 'Magmaris', 'Coronary Artery Disease', 'PCI'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32881396/', 'label': 'Primary end point of the study'}]}, 'descriptionModule': {'briefSummary': 'The registry will investigate the clinical performance and long-term safety of Magmaris in a real world setting', 'detailedDescription': 'Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy.Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.\n\nThe aim of this observational registry is to investigate the clinical performance and long-term safety of Magmaris in a real world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion cirteria\n\n1. Subject is ≥18 years of Age\n2. Subject must be willing to sign a Patient Informed Consent (PIC) or Patient Data Release Form (PDRF) where applicable\n3. Symptomatic coronary artery disease\n4. Subject with a maximum of two single de novo lesions in two different major epicardial vessels\n5. Target lesion length ≤21 mm by QCA or by visual estimation\n6. Target lesion stenosis by visual estimation: \\>50% - \\<100% and TIMI flow ≥1\n7. Subject is eligible for Dual Anti Platelet Therapy (DAPT)\n8. Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used\n\nExclusion criteria\n\n1. Pregnant and/or breast feeding females or females who intend to become pregnant during the time of the registry\n2. Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, heparin or any other anticoagulant/antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs; or the scaffold materials including Magnesium, Yttrium, Neodymium, Zirconium,Gadolinium, Dysprosium, Tantalum that cannot beadequately pre-medicated\n3. Subjects on dialysis\n4. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST Elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment\n5. Documented left ventricular ejection fraction (LVEF) \\<30%\n6. Restenotic target lesion\n7. Thrombus in target vessel\n8. Target lesion is located in or supplied by a diseased (defined as vessel irregularity per angiogram and \\>20% stenosed lesion by visual estimation) arterial or venous bypass graft\n9. Left main coronary artery disease\n10. Ostial target lesion (within 5.0 mm of vessel origin)\n11. Target lesion involves a side branch ≥2.0 mm in Diameter\n12. Target vessel (including side branches) has second lesion which requires treatment according to the investigator's discretion\n13. Unsuccessful pre-dilatation, defined as residual Stenosis rate more than 20% measured by QCA and / or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)\n14. Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained\n15. Currently participating in another study and Primary endpoint is not reached yet.\n16. Planned interventional treatment of any target or nontarget vessel\n\nParticipating Countries\n\nAustralia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Malaysia, New Zealand, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, United Kingdom"}, 'identificationModule': {'nctId': 'NCT02817802', 'acronym': 'BIOSOLVE-IV', 'briefTitle': 'BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik AG'}, 'officialTitle': 'BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV', 'orgStudyIdInfo': {'id': 'C1503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Magmaris', 'description': 'Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold', 'interventionNames': ['Device: Magmaris']}], 'interventions': [{'name': 'Magmaris', 'type': 'DEVICE', 'description': 'PCI (Magmaris)', 'armGroupLabels': ['Magmaris']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Middelheim Cardiologiy', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Kowloon', 'country': 'Hong Kong', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Stefan Verheye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Institute Middelheim, Antwerpen, Belgium'}, {'name': 'Michael Kang-Yin Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Elizabeth Hospital, Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The primary outcome data will be shared after the publication of it.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}