Coronary Artery DiseaseNCT04679740
Resorbable Magnesium Scaffolds Registry
An observational study of Coronary Artery Disease, run by Biotronik AG at 13 sites in 7 countries.
Trial summary
The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for… 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 and Freesolve
- Type of treatment
- Medical device
- How many people
- 1,106 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 18 Nov 2020to May 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions
Who may be able to join
- According to the IFU
Who cannot join
- According to the IFU
Trial locations and contacts
13 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 7 countries
Germany5 sites, 1 recruiting
- Recruiting
Heart Center Segeberger Kliniken
Bad Segeberg, 23795
Holger Nef, MD
Ralph Toelg, MD
- Completed
Krankenhaus Buchholz
Buchholz, 21244
- Completed
Klinikum Westfalen, Knappschaft KH
Dortmund, 44309
- Completed
Klinikum Herford
Herford, 32049
- Completed
Herz-und Gefäßzentrum Oberallgäu-Kempten
Kempten
Switzerland3 sites, 3 recruiting
- Recruiting
Lindenhofspital
Bern, 3001
Samera Shakir, MD
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1005
Stephane Fournier, MD
- Recruiting
Solothurner Spitäler AG
Olten, 4600
Yves Laurent Bayard, MD
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino
Milan, Lombardy, 20138
Stefano Galli, MD
Poland1 site, 1 recruiting
- Recruiting
1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
Lublin
Grzegorz Sobieszek, MD
About this study
Official title: RMS (Resorbable Magnesium Scaffolds) Registry
The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).
- Conditions
- Coronary Artery Disease
- Being tested
- Magmaris, Freesolve
- Keywords
- Registry, Magmaris, Coronary Artery Disease, PCI, Resorbable Magnesium Scaffolds, Freesolve
- 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.
MagmarisDevice
Also called Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
MAGMARIS is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length.
FreesolveDevice
Also called Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System
Freesolve is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length.
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start18 Nov 2020
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,106 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefano Galli, MD, Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679740
- Sponsor's protocol ID
- C1908
- Status last verified
- Nov 2025
- First submitted
- 17 Dec 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The primary outcome data will be shared after the publication of it.
Publications
Wolbert S, Schmidt T, Wittek F, Mayer B, Raake P, Bongiovanni D, Torzewski J. One-year outcomes of bioresorbable magnesium scaffold implantation in complex coronary lesions. Front Cardiovasc Med. 2026 Jun 12;13:1854686. doi: 10.3389/fcvm.2026.1854686. eCollection 2026.
PubMed 42368841
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RMS (Resorbable Magnesium Scaffolds) Registry
- ClinicalTrials.gov ID
- NCT04679740
- Acronym / sponsor ID
- C1908
- Conditions
- Coronary Artery Disease
- Keywords
- Registry, Magmaris, Coronary Artery Disease, PCI, Resorbable Magnesium Scaffolds, Freesolve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,106 participants (estimated)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions
Key inclusion criteria (1 listed)
- According to the IFU
Key exclusion criteria (1 listed)
- According to the IFU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagmarisAlso: Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium ScaffoldMAGMARIS is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length. | Device | – |
| FreesolveAlso: Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) SystemFreesolve is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length. | Device | – |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months
The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 42368841Wolbert S, Schmidt T, Wittek F, Mayer B, Raake P, Bongiovanni D, Torzewski J. One-year outcomes of bioresorbable magnesium scaffold implantation in complex coronary lesions. Front Cardiovasc Med. 2026 Jun 12;13:1854686. doi: 10.3389/fcvm.2026.1854686. eCollection 2026.
- Individual participant dataSharing planned: No. The primary outcome data will be shared after the publication of it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Galli, MD principal investigator
Centro Cardiologico Monzino
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Biotronik AG at 13 sites in 7 countries.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Switzerland, Australia, Italy, Latvia and 2 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Gattiglio, Dr. (+41754295843, marina.gattiglio@teleflex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (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 NCT04679740, which also lists 1 linked publication.
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 21 Nov 2025.