Coronary Artery DiseaseBIOSOLVE-IVNCT02817802
BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
An observational study of Coronary Artery Disease, run by Biotronik AG at 2 sites in 2 countries.
Trial summary
The registry will investigate the clinical performance and long-term safety of Magmaris in a real world setting 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
- Type of treatment
- Medical device
- How many people
- 2,066 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2016to Oct 2025
- How long will I take part?
- 5 Years
- 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: Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
Who may be able to join
- Subject is ≥18 years of Age
- Subject must be willing to sign a Patient Informed Consent (PIC) or Patient Data Release Form (PDRF) where applicable
- 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 by visual estimation: >50% - <100% 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 breast feeding females or females who intend to become pregnant during the time of the registry
- Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, 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 beadequately 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%
- Restenotic target lesion
Show all 18Show fewer
- 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 lesion involves a side branch ≥2.0 mm in Diameter
- 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 more than 20% measured by QCA 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 target or nontarget vessel
- Participating Countries
- Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Malaysia, New Zealand, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, United Kingdom
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The registry will investigate the clinical performance and long-term safety of Magmaris in a real world setting
Read the detailed description
Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy.Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.
The aim of this observational registry is to investigate the clinical performance and long-term safety of Magmaris in a real world setting.
- Conditions
- Coronary Artery Disease
- Being tested
- Magmaris
- Keywords
- Registry, Magmaris, Coronary Artery Disease, PCI
- 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
PCI (Magmaris)
| Study group | Role | What they receive |
|---|---|---|
| Magmaris | Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold Receives: Device: Magmaris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)* at 12 months
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion14 Jul 2020
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2,066 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Verheye, MD, Principal investigator, Cardiovascular Institute Middelheim, Antwerpen, BelgiumMichael Kang-Yin Lee, MD, Principal investigator, Queen Elizabeth Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817802
- Sponsor's protocol ID
- C1503
- Acronym
- BIOSOLVE-IV
- Status last verified
- Feb 2023
- First submitted
- 27 Jun 2016
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The primary outcome data will be shared after the publication of it.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
- ClinicalTrials.gov ID
- NCT02817802
- Acronym / sponsor ID
- BIOSOLVE-IV / C1503
- Conditions
- Coronary Artery Disease
- Keywords
- Registry, Magmaris, Coronary Artery Disease, PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,066 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- 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 will investigate the clinical performance and long-term safety of Magmaris in a real world setting
Detailed description
Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy.Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.
The aim of this observational registry is to investigate the clinical performance and long-term safety of Magmaris in a real world setting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magmaris | – | Device: MagmarisMagmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold |
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 (8 listed)
- Subject is ≥18 years of Age
- Subject must be willing to sign a Patient Informed Consent (PIC) or Patient Data Release Form (PDRF) where applicable
- 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
Key exclusion criteria (18 listed)
- Pregnant and/or breast feeding females or females who intend to become pregnant during the time of the registry
- Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, 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 beadequately 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%
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 |
|---|---|---|
| MagmarisPCI (Magmaris) | Device | Magmaris |
Primary outcome
Target Lesion Failure (TLF)* at 12 months
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Primary end point of the studyLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Stefan Verheye, MD principal investigator
Cardiovascular Institute Middelheim, Antwerpen, Belgium
Michael Kang-Yin Lee, MD principal investigator
Queen Elizabeth Hospital, Hong Kong
2 sites in 2 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 2 sites in 2 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 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: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Hong Kong. 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?
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 (TLF)* at 12 months (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2023.