BIOSOLVE-IV Magmaris Swiss Satellite Registry
Study Details
Study Description
Brief Summary
BIOSOLVE-IV Magmaris Swiss Satellite Registry is a prospective, single-arm, multicenter, nationwide open label registry. It is planned to enroll 200 subjects in up to 12 participating sites in Switzerland. After percutaneous coronary intervention (PCI) with the Magmaris scaffold and signature of the informed consent form, all subjects will be followed through hospital discharge and will undergo follow up evaluations at 6, 12 and 24 months post procedure. The follow up evaluations, part of the standard care can be either performed on site (12 months) or by phone (6 and 24 months) and according to routine clinical practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Target Lesion Failure at 12 months [12 months]
Target Lesion Failure (TLF, a composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction, and clinically driven Target Lesion Revascularization) at 12 months
Secondary Outcome Measures
- Target Lesion Failure [6 months and annually thereafter up to 2 years post-procedure]
Target Lesion Failure (TLF) at 6, 12 and 24 months
- Clinically driven Target Lesion Revascularization [6, 12 months and 24 months post-procedure]
Clinically driven Target Lesion Revascularization (TLR) at 6, 12 and 24 months
- Clinically driven Target Vessel Revascularization [6, 12 months and 24 months post-procedure]
Clinically driven Target Vessel Revascularization (TVR) at 6, 12 and 24 months
- Cardiac death [6, 12 and 24 months post-procedure]
Cardiac death at 6, 12 and 24 months
- Target Vessel Myocardial Infarction [6, 12 and 24 months post-procedure]
Target Vessel Myocardial Infarction (MI) at 6, 12 and 24 months
- Scaffold thrombosis [6, 12 and 24 months post-procedure]
Scaffold thrombosis at 6, 12 and 24 months
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is ≥18 years of age
-
Subject must be willing to sign a Patient Informed Consent
-
Symptomatic coronary artery disease
-
Subject with a maximum of two single de novo lesions in two different major epicardial vessels
-
Target lesion length ≤ 21 mm by QCA or by visual estimation
-
Target lesion stenosis >50% and <100% by visual estimation, and TIMI flow ≥1.
-
Subject is eligible for Dual Anti Platelet Therapy (DAPT)
-
Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used
Exclusion Criteria:
-
Pregnant and/or breastfeeding females or females who intend to become pregnant during the time of the registry
-
Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, 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 be adequately pre-medicated
-
Subjects on dialysis
-
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
-
Documented left ventricular ejection fraction (LVEF) ≤30% as documented within maximum 6 months prior to the procedure
-
Heavily calcified or extremely tortuous lesions
-
Bifurcation lesion requiring side branch intervention, if side branches >2 mm in diameter are involved
-
Restenotic target lesion
-
Thrombus in target vessel
-
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
-
Left main coronary artery disease
-
Ostial target lesion (within 5.0 mm of vessel origin)
-
Target vessel (including side branches) has second lesion which requires treatment according to the investigator's discretion
-
Unsuccessful pre-dilatation, defined as residual stenosis rate >20% by visual estimation and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
-
Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
-
Currently participating in another study and primary endpoint is not reached yet
-
Planned interventional treatment of any non-target vessel within 30 days post procedure
-
Planned intervention of the target vessel within 6-month after the index procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unité de Cardiologie interventionnelle, Service de cardiologie, Hôpitaux Universitaires de Genève | Genève | Switzerland | 1205 | |
| 2 | Kantonsspital Baselland, Kardiologie | Liestal | Switzerland | 4410 | |
| 3 | Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie | Morges | Switzerland | 1110 | |
| 4 | Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie | Saint Gallen | Switzerland | 9000 | |
| 5 | Hôpital du Valais Sion | Sion | Switzerland | 1950 | |
| 6 | HFR Fribourg, Cardiologie | Villars-sur-Glâne | Switzerland | 1752 |
Sponsors and Collaborators
- University Hospital, Geneva
Investigators
- Principal Investigator: Juan F Iglesias, MD, University Hospital, Geneva
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-01420