Coronary Artery DiseaseBIFSORB P-IINCT03027856
The BIFSORB Pilot Study II
A study testing Magmaris in people with Coronary Artery Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to 31 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Stable angina pectoris
- Stabilized non-ST elevation myocardial infarction
- Silent angina pectoris
- Age > 18 years
- De novo coronary bifurcation lesion at LAD/diagonal, CX/obtuse marginal or RCA-PDA/posterolateral branch
- All Medina classes except Medina x.x.1.
Show all 9Show fewer
- Diameter of side branch ≥ 2.5 mm
- Side branch diameter stenosis less than 50%
- Signed informed consent
Who cannot join
- ST-elevation infarction within 48 hours
- Expected survival < 1 year
- Severe heart failure (NYHA≥III)
- S-creatinine > 120 µmol/L or GFR < 0.45 mL/min per 1.73 m2
- Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus
- Unable to cover main vessel lesion with one stent
- Severe tortuosity
- Severe calcification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II
The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.
Read the detailed description
Bioresorbable stents are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.
The aim of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.
Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and feasible.
Methods:
The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients. Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for clinical endpoints until 5 years.
Written informed consent is required before the procedure is performed. Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the stent.
At baseline, the target lesion is assessed by OCT before, during and after implantation of the Magmaris BRS. OCT assessment is performed again at 1- and 12-month follow-up, or before if the patient is readmitted with a possible target lesion failure.
The operator is not blinded to the OCT images as pre-PCI images should be used for sizing and positioning of the stent, and procedural OCT images are used to optimize stent implantation before performing final OCT.
- Conditions
- Coronary Artery Disease
- Being tested
- Magmaris
- Keywords
- Percutaneous intervention (PCI), Optical coherence tomography (OCT), Bifurcation lesion, Bioresorbable stents (BRS)
- 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
Implantation of a sirolimus eluting bioresorbable magnesium stent
| Study group | Role | What they receive |
|---|---|---|
| Magmaris | Experimental | Implantation of sirolimus eluting bioresorbable magnesium stent Receives: Device: Magmaris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Measured: 1 month
Index of adverse vessel wall features by OCT
Index based on: side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain
Measured: 1 month
Secondary outcomes (37)
Optical coherence tomography endpoint: Acute malapposition
Measured: Baseline
Optical coherence tomography endpoint: Acquired malapposition
Measured: 1 month
Optical coherence tomography endpoint: Persistent malapposition
Measured: 1 month
Optical coherence tomography endpoint: Coverage of jailing struts
Measured: 1 month
Optical coherence tomography endpoint: Extra stent lumen (including evaginations)
Measured: Baseline and 1 month
Optical coherence tomography endpoint: Late stent recoil
Measured: 1 month
Optical coherence tomography endpoint: Stent fracture
Measured: Baseline and 1 month
Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts
Measured: Baseline and 1 month
Optical coherence tomography endpoint: Ostial strut loss
Measured: Baseline and 1 month
Optical coherence tomography endpoint: Mean neointimal thickness
Measured: 1 month
Optical coherence tomography endpoint: Stent strut coverage
Measured: 1 month
Optical coherence tomography endpoint: Minimal luminal area in segmental analysis
Measured: Baseline and 1 month
Optical coherence tomography endpoint: Minimal stent area in segmental analysis
Measured: Baseline and 1 month
Optical coherence tomography endpoint: Minimum stent expansion area %
Measured: Baseline and 1 month
Optical coherence tomography endpoint: Segmental area stenosis
Measured: Baseline and 1 month
Optical coherence tomography endpoint: Healing above calcified plaque
Measured: 1 month
Optical coherence tomography endpoint: Healing above lipid plaque
Measured: 1 month
Optical coherence tomography endpoint: Acute thrombus on struts
Measured: Baseline
Optical coherence tomography endpoint: Late thrombus on struts
Measured: 1 month
Optical coherence tomography endpoint: Acute expansion
Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
Measured: Baseline
Optical coherence tomography endpoint: Late recoil
Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
Measured: 1 month
Angiographic endpoint: Ostial side branch area stenosis
Measured: Baseline and 1 month
Angiographic endpoint: Ostial side branch acute gain after main vessel stenting
Measured: Baseline
Angiographic endpoint: Ostial side branch late loss
Measured: 1 month
Angiographic endpoint: Ostial distal main vessel area stenosis
Measured: Baseline and 1 month
Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting
Measured: Baseline
Angiographic endpoint: Ostial distal main vessel late loss
Measured: 1 month
Angiographic endpoint: Proximal main vessel area stenosis
Measured: Baseline and 1 month
Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting
Measured: Baseline
Angiographic endpoint: Proximal main vessel late loss
Measured: 1 month
Angiographic endpoint: Minimal luminal area of all segments
Measured: Baseline and 1 month
Procedural endpoint: Procedure time
Measured: Intraoperative
Procedural endpoint: Contrast use in mL
Measured: Intraoperative
Procedural endpoint: Fluoroscopy time
Measured: Intraoperative
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Measured: 6 months
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Measured: 24 months
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startSep 2016
- Primary completion19 Aug 2019
- Study completion31 Dec 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evald Hoej Christiansen, Aarhus University Hospital Skejby
- Investigators
- Evald H Christiansen, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027856
- Sponsor's protocol ID
- 1-10-72-194-16
- Acronym
- BIFSORB P-II
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2016
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II
- ClinicalTrials.gov ID
- NCT03027856
- Acronym / sponsor ID
- BIFSORB P-II / 1-10-72-194-16
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous intervention (PCI), Optical coherence tomography (OCT), Bifurcation lesion, Bioresorbable stents (BRS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Jan 2017 (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 purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.
Detailed description
Bioresorbable stents are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.
The aim of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.
Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and feasible.
Methods:
The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients. Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for clinical endpoints until 5 years.
Written informed consent is required before the procedure is performed. Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the stent.
At baseline, the target lesion is assessed by OCT before, during and after implantation of the Magmaris BRS. OCT assessment is performed again at 1- and 12-month follow-up, or before if the patient is readmitted with a possible target lesion failure.
The operator is not blinded to the OCT images as pre-PCI images should be used for sizing and positioning of the stent, and procedural OCT images are used to optimize stent implantation before performing final OCT.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magmaris | Experimental | Device: MagmarisImplantation of sirolimus eluting bioresorbable magnesium stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stable angina pectoris
- Stabilized non-ST elevation myocardial infarction
- Silent angina pectoris
- Age > 18 years
- De novo coronary bifurcation lesion at LAD/diagonal, CX/obtuse marginal or RCA-PDA/posterolateral branch
Key exclusion criteria (8 listed)
- ST-elevation infarction within 48 hours
- Expected survival < 1 year
- Severe heart failure (NYHA≥III)
- S-creatinine > 120 µmol/L or GFR < 0.45 mL/min per 1.73 m2
- Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus
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 |
|---|---|---|
| MagmarisImplantation of a sirolimus eluting bioresorbable magnesium stent | Device | Magmaris |
Primary outcome
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Time frame: 1 month
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Index of adverse vessel wall features by OCT
Time frame: 1 month
Index based on: side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain
37 secondary outcomes
Optical coherence tomography endpoint: Acute malapposition
Time frame: Baseline
Optical coherence tomography endpoint: Acquired malapposition
Time frame: 1 month
Optical coherence tomography endpoint: Persistent malapposition
Time frame: 1 month
Optical coherence tomography endpoint: Coverage of jailing struts
Time frame: 1 month
Optical coherence tomography endpoint: Extra stent lumen (including evaginations)
Time frame: Baseline and 1 month
Optical coherence tomography endpoint: Late stent recoil
Time frame: 1 month
Optical coherence tomography endpoint: Stent fracture
Time frame: Baseline and 1 month
Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts
Time frame: Baseline and 1 month
Optical coherence tomography endpoint: Ostial strut loss
Time frame: Baseline and 1 month
Optical coherence tomography endpoint: Mean neointimal thickness
Time frame: 1 month
Optical coherence tomography endpoint: Stent strut coverage
Time frame: 1 month
Optical coherence tomography endpoint: Minimal luminal area in segmental analysis
Time frame: Baseline and 1 month
Optical coherence tomography endpoint: Minimal stent area in segmental analysis
Time frame: Baseline and 1 month
Optical coherence tomography endpoint: Minimum stent expansion area %
Time frame: Baseline and 1 month
Optical coherence tomography endpoint: Segmental area stenosis
Time frame: Baseline and 1 month
Optical coherence tomography endpoint: Healing above calcified plaque
Time frame: 1 month
Optical coherence tomography endpoint: Healing above lipid plaque
Time frame: 1 month
Optical coherence tomography endpoint: Acute thrombus on struts
Time frame: Baseline
Optical coherence tomography endpoint: Late thrombus on struts
Time frame: 1 month
Optical coherence tomography endpoint: Acute expansion
Time frame: Baseline
Optical coherence tomography endpoint: Late recoil
Time frame: 1 month
Angiographic endpoint: Ostial side branch area stenosis
Time frame: Baseline and 1 month
Angiographic endpoint: Ostial side branch acute gain after main vessel stenting
Time frame: Baseline
Angiographic endpoint: Ostial side branch late loss
Time frame: 1 month
Angiographic endpoint: Ostial distal main vessel area stenosis
Time frame: Baseline and 1 month
Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting
Time frame: Baseline
Angiographic endpoint: Ostial distal main vessel late loss
Time frame: 1 month
Angiographic endpoint: Proximal main vessel area stenosis
Time frame: Baseline and 1 month
Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting
Time frame: Baseline
Angiographic endpoint: Proximal main vessel late loss
Time frame: 1 month
Angiographic endpoint: Minimal luminal area of all segments
Time frame: Baseline and 1 month
Procedural endpoint: Procedure time
Time frame: Intraoperative
Procedural endpoint: Contrast use in mL
Time frame: Intraoperative
Procedural endpoint: Fluoroscopy time
Time frame: Intraoperative
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Time frame: 6 months
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Time frame: 24 months
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Evald H Christiansen, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magmaris in people with Coronary Artery Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death (time frame: 1 month). The study lists 2 primary outcomes in all. 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 2 Jan 2026.