BIOSOLVE-IV Magmaris Swiss Satellite Registry

NCT04025788 | Terminated FDA Device

• 1 other identifier: 2018-01420
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Target Lesion Failure

  6 months and annually thereafter up to 2 years post-procedure

• Clinically driven Target Lesion Revascularization

  6, 12 months and 24 months post-procedure

• Clinically driven Target Vessel Revascularization

  6, 12 months and 24 months post-procedure

• Cardiac death

  6, 12 and 24 months post-procedure

• Target Vessel Myocardial Infarction

  6, 12 and 24 months post-procedure

Interventions

Magmaris Resorbable Magnesium Scaffold (RMS) DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (6)

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

Geneva, 1205, Switzerland

Location

Kantonsspital Baselland, Kardiologie

Liestal, 4410, Switzerland

Location

Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie

Morges, 1110, Switzerland

Location

Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie

Sankt Gallen, 9000, Switzerland

Location

Hôpital du Valais Sion

Sion, 1950, Switzerland

Location

HFR Fribourg, Cardiologie

Villars-sur-Glâne, 1752, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Juan F Iglesias, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: March 26, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

CH (6)