BIOSOLVE-IV Magmaris Swiss Satellite Registry

BIOTRONIKS-Safety and Performance in de Novo Lesion of Native Coronary Arteries With Magmaris (BIOSOLVE)-IV Magmaris Swiss Satellite Registry

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Magmaris Resorbable Magnesium Scaffold (RMS)

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Switzerland
  • Genève, Switzerland, 1205
    • Unité de Cardiologie interventionnelle, Service de cardiologie, Hôpitaux Universitaires de Genève
  • Liestal, Switzerland, 4410
    • Kantonsspital Baselland, Kardiologie
  • Morges, Switzerland, 1110
    • Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie
  • Saint Gallen, Switzerland, 9000
    • Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie
  • Sion, Switzerland, 1950
    • Hôpital du Valais Sion
  • Villars-sur-Glâne, Switzerland, 1752
    • HFR Fribourg, Cardiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure at 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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure	Target Lesion Failure (TLF) at 6, 12 and 24 months	6 months and annually thereafter up to 2 years post-procedure
Clinically driven Target Lesion Revascularization	Clinically driven Target Lesion Revascularization (TLR) at 6, 12 and 24 months	6, 12 months and 24 months post-procedure
Clinically driven Target Vessel Revascularization	Clinically driven Target Vessel Revascularization (TVR) at 6, 12 and 24 months	6, 12 months and 24 months post-procedure
Cardiac death	Cardiac death at 6, 12 and 24 months	6, 12 and 24 months post-procedure
Target Vessel Myocardial Infarction	Target Vessel Myocardial Infarction (MI) at 6, 12 and 24 months	6, 12 and 24 months post-procedure
Scaffold thrombosis	Scaffold thrombosis at 6, 12 and 24 months	6, 12 and 24 months post-procedure

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Juan F Iglesias, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2018-01420

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes