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Coronary Artery DiseaseNCT04025788

BIOSOLVE-IV Magmaris Swiss Satellite Registry

An observational study of Coronary Artery Disease, run by University Hospital, Geneva at 6 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Magmaris Resorbable Magnesium Scaffold (RMS)
Type of treatment
Medical device
How many people
10 participants
Where
6 sitesSwitzerland
Study dates
26 Mar 2019to 1 Jan 2022
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Switzerland6 sites

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

    Geneva, 1205

  • Kantonsspital Baselland, Kardiologie

    Liestal, 4410

  • Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie

    Morges, 1110

  • Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie

    Sankt Gallen, 9000

  • Hôpital du Valais Sion

    Sion, 1950

  • HFR Fribourg, Cardiologie

    Villars-sur-Glâne, 1752

Other trials in Switzerland

About this study

Official title: 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.

Being tested
Magmaris Resorbable Magnesium Scaffold (RMS)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (6)

  1. Target Lesion Failure

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

    Measured: 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

    Measured: 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

    Measured: 6, 12 months and 24 months post-procedure

  4. Cardiac death

    Cardiac death at 6, 12 and 24 months

    Measured: 6, 12 and 24 months post-procedure

  5. Target Vessel Myocardial Infarction

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

    Measured: 6, 12 and 24 months post-procedure

  6. Scaffold thrombosis

    Scaffold thrombosis at 6, 12 and 24 months

    Measured: 6, 12 and 24 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start26 Mar 2019
  3. Primary completion1 Jan 2022
  4. Study completion1 Jan 2022

Why it stopped: Slow enrolment. New generation BRS available

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04025788
Sponsor's protocol ID
2018-01420
Other IDs
2018
Status last verified
Jul 2022
First submitted
17 Jul 2019
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by University Hospital, Geneva at 6 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow enrolment. New generation BRS available). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04025788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

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