BIOSOLVE-IV Magmaris Swiss Satellite Registry

NCT ID: NCT04025788

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-26
• Study Completion Date: 2022-01-01

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Magmaris Resorbable Magnesium Scaffold (RMS)

Subjects will undergo a percutaneous coronary intervention for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of two single de novo lesions in two separate major epicardial vessels are allowed.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

IGLESIAS Juan Fernando

Medical Doctor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan F Iglesias, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Unité de Cardiologie interventionnelle, Service de cardiologie, Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Kantonsspital Baselland, Kardiologie

Liestal, , Switzerland

Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie

Morges, , Switzerland

Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie

Sankt Gallen, , Switzerland

Hôpital du Valais Sion

Sion, , Switzerland

HFR Fribourg, Cardiologie

Villars-sur-Glâne, , Switzerland

Countries

Switzerland

Other Identifiers

2018-01420

Identifier Type: -

Identifier Source: org_study_id