Clinical trial NCT04025788: BIOSOLVE-IV Magmaris Swiss Satellite Registry
Official title: BIOTRONIKS-Safety and Performance in de Novo Lesion of Native Coronary Arteries With Magmaris (BIOSOLVE)-IV Magmaris Swiss Satellite Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BIOSOLVE-IV Magmaris Swiss Satellite Registry will include male and female subjects requiring a treatment of de novo coronary artery lesions with Magmaris.

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.


Eligibility 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

Primary outcomes:
measure: Target Lesion Failure at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Target Lesion Failure
timeFrame: 6 months and annually thereafter up to 2 years post-procedure
measure: Clinically driven Target Lesion Revascularization
timeFrame: 6, 12 months and 24 months post-procedure
measure: Clinically driven Target Vessel Revascularization
timeFrame: 6, 12 months and 24 months post-procedure
measure: Cardiac death
timeFrame: 6, 12 and 24 months post-procedure
measure: Target Vessel Myocardial Infarction
timeFrame: 6, 12 and 24 months post-procedure
measure: Scaffold thrombosis
timeFrame: 6, 12 and 24 months post-procedure
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: Unité de Cardiologie interventionnelle, Service de cardiologie, Hôpitaux Universitaires de Genève
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland, Kardiologie
city: Morges
country: Switzerland
facility: Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie
city: Saint Gallen
country: Switzerland
facility: Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie
city: Sion
country: Switzerland
facility: Hôpital du Valais Sion
city: Villars-sur-Glâne
country: Switzerland
facility: HFR Fribourg, Cardiologie
Study officials:
affiliation: University Hospital, Geneva
name: Juan F Iglesias, MD
role: PRINCIPAL_INVESTIGATOR
References: