BIOSOLVE-IV Magmaris Swiss Satellite Registry

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04025788
• Other study ID #: 2018-01420
• Status: Terminated
• Start date: March 26, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: July 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Unité de Cardiologie interventionnelle, Service de cardiologie, Hôpitaux Universitaires de Genève	Genève
Switzerland	Kantonsspital Baselland, Kardiologie	Liestal
Switzerland	Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie	Morges
Switzerland	Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie	Saint Gallen
Switzerland	Hôpital du Valais Sion	Sion
Switzerland	HFR Fribourg, Cardiologie	Villars-sur-Glâne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Target Lesion Failure	Target Lesion Failure (TLF) at 6, 12 and 24 months	6 months and annually thereafter up to 2 years post-procedure
Secondary	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
Secondary	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
Secondary	Cardiac death	Cardiac death at 6, 12 and 24 months	6, 12 and 24 months post-procedure
Secondary	Target Vessel Myocardial Infarction	Target Vessel Myocardial Infarction (MI) at 6, 12 and 24 months	6, 12 and 24 months post-procedure
Secondary	Scaffold thrombosis	Scaffold thrombosis at 6, 12 and 24 months	6, 12 and 24 months post-procedure