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TerminatedNCT04025788Updated Aug 2, 2022

BIOSOLVE-IV Magmaris Swiss Satellite Registry

An observational study in Coronary Artery Disease, sponsored by University Hospital, Geneva. Terminated at 6 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by University Hospital, Geneva · Observational

Why this study was terminated
Slow enrolment. New generation BRS available
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 10 is below the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Target follow-up
24 Months
Patient registry
Yes

Interventions

  • DeviceMagmaris 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.

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. Target Lesion Failure

    Target Lesion Failure (TLF) at 6, 12 and 24 months

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

  2. Clinically driven Target Lesion Revascularization

    Clinically driven Target Lesion Revascularization (TLR) at 6, 12 and 24 months

    Time frame: 6, 12 months and 24 months post-procedure

  3. Clinically driven Target Vessel Revascularization

    Clinically driven Target Vessel Revascularization (TVR) at 6, 12 and 24 months

    Time frame: 6, 12 months and 24 months post-procedure

  4. Cardiac death

    Cardiac death at 6, 12 and 24 months

    Time frame: 6, 12 and 24 months post-procedure

  5. Target Vessel Myocardial Infarction

    Target Vessel Myocardial Infarction (MI) at 6, 12 and 24 months

    Time frame: 6, 12 and 24 months post-procedure

  6. Scaffold thrombosis

    Scaffold thrombosis at 6, 12 and 24 months

    Time frame: 6, 12 and 24 months post-procedure

07

Study locations

6 sites
  • Unité de Cardiologie interventionnelle, Service de cardiologie, Hôpitaux Universitaires de Genève
    Genève, 1205, Switzerland
  • Kantonsspital Baselland, Kardiologie
    Liestal, 4410, Switzerland
  • Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie
    Morges, 1110, Switzerland
  • Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie
    Saint Gallen, 9000, Switzerland
  • Hôpital du Valais Sion
    Sion, 1950, Switzerland
  • HFR Fribourg, Cardiologie
    Villars-sur-Glâne, 1752, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04025788
Lead sponsor
University Hospital, Geneva
Responsible party
IGLESIAS Juan Fernando (Medical Doctor, Principal Investigator, University Hospital, Geneva) — Principal investigator
First posted
Jul 19, 2019
Start date
Mar 26, 2019
Primary completion
Jan 1, 2022
Completion
Jan 1, 2022
Last update
Aug 2, 2022

Study contacts

Juan F Iglesias, MD
principal investigator · University Hospital, Geneva

Oversight

Data monitoring committee
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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