Coronary Artery DiseaseNCT04157153
First in Men Study: BIOMAG-I
A study testing Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in people with Coronary Artery Disease, run by Biotronik AG at 14 sites in 8 countries.
Trial summary
A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 14 sitesin 8 countries
- Study dates
- 27 Apr 2020to Feb 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is > 18 years and < 80 years of age
- Written subject informed consent available prior to PCI
- Subject eligible for PCI
- Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions and can be covered with 1 device each
- Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used
- Target lesion length ≤ 28 mm by visual estimation, depending on the scaffold size used
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- Target lesion stenosis by visual estimation > 50% - < 100% and TIMI flow ≥1 (assisted by e.g. QCA / IVUS /FFR).
- Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients without angiographic evidence of thrombus at target lesion
- Eligible for Dual Anti Platelet Therapy (DAPT)
Who cannot join
- Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- 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.
- Left main coronary artery disease
- Three-vessels with coronary artery disease requiring treatment at time of procedure
- Planned interventional treatment of any non-target vessel within 12-month post-procedure
- Subjects on dialysis
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- Planned intervention of the target vessel post index procedure
- Ostial target lesion (within 5.0 mm of vessel origin)
- Target lesion involves a side branch >2.0 mm in diameter
- Documented left ventricular ejection fraction (LVEF) ≤ 30% within the last 6 months
- Heavily calcified lesion
- Target lesion is located in or supplied by an arterial or venous bypass graft
- Target lesion requiring treatment with a device other than the non-compliant pre-dilatation balloon or scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.)
- Unsuccessful pre-dilatation, defined as a residual stenosis rate more than 20%, estimated by any method and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
- Known allergies to: Acetylsalicylic Acid (ASA), P2Y12 inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
- Subject is receiving an oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has a known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus) diabetes mellitus is not excluded)
- A stenosis located proximal or distal to the target lesion that might require future revascularization or an impede run off detected during diagnostic angiography
- Life expectancy less than 1 year
- Planned surgery or dental surgical procedure within 6 months after index procedure unless DAPT will be maintained
- In the investigators opinion, subject will not be able to comply with the follow-up requirements
- Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
Trial locations and contacts
14 sites in 8 countries.
14 sites in 8 countries
Germany5 sites
Segeberger Kliniken
Bad Segeberg
Herz-und Gefäßzentrum Oberallgäu-Kempten
Kempten
Johannes Wesling Klinikum Minden
Minden
Deutsches Herzzentrum
Münich
Rheinland Klinikum Lukaskrankenhaus Neuss
Neuss
Belgium3 sites
Algemeen Ziekenhuis Middelheim
Antwerp
Ziekenhuis Oost-Limburg
Genk
UZ Leuven Gasthuisberg
Leuven
About this study
Official title: BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries
A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.
Read the detailed description
Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 60 months post procedure.
All subjects will undergo an angiographic follow-up at 6- and 12-month follow up.
IVUS, (including IVUS-VH documentation) and OCT will be performed for all subjects at 6-month and 12-month follow-up (if the safety of the subject allows it and as per the investigator's decision).
Vasomotion will be assessed angiographically with Acetylcholine followed by Nitroglycerine at 12 months follow up in a subgroup of subjects, upon the investigators discretion and if subject consents.
- Conditions
- Coronary Artery Disease
- Being tested
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- 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.
Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium ScaffoldDevice
Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 60 months. Receives: Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
In scaffold late lumen loss
Independent Core Lab Assessment
Measured: At 6 months after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start27 Apr 2020
- Primary completionAug 2022 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Haude, Prof, Principal investigator, Rheinland Klinikum Lukaskrankenhaus Neuss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157153
- Sponsor's protocol ID
- C1702
- Status last verified
- Jul 2022
- First submitted
- 6 Nov 2019
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aytekin A, Seguchi M, Xhepa E, Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Garcia-Garcia HM, Waksman R, Joner M. The Impact of Underlying Plaque Characteristics Following the Third-Generation Resorbable Magnesium Scaffold Implantation: An Intravascular OCT Assessment up to 12-Months. Catheter Cardiovasc Interv. 2025 Jun;105(7):1563-1571. doi: 10.1002/ccd.31486. Epub 2025 Mar 16.
PubMed 40091374Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth GG, Joner M, Toelg R, Wiemer M, Olivecrano G, Vermeersch P, Garcia-Garcia HM, Waksman R. A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study. EuroIntervention. 2023 Aug 7;19(5):e414-e422. doi: 10.4244/EIJ-D-23-00326.
PubMed 37334655Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth G, Joner M, Toelg R, Wiemer M, Olivecrona G, Vermeersch P, Garcia-Garcia HM, Waksman R. Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study. EClinicalMedicine. 2023 Apr 17;59:101940. doi: 10.1016/j.eclinm.2023.101940. eCollection 2023 May.
PubMed 37113674
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries
- ClinicalTrials.gov ID
- NCT04157153
- Acronym / sponsor ID
- C1702
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Nov 2019 (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.
A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.
Detailed description
Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 60 months post procedure.
All subjects will undergo an angiographic follow-up at 6- and 12-month follow up.
IVUS, (including IVUS-VH documentation) and OCT will be performed for all subjects at 6-month and 12-month follow-up (if the safety of the subject allows it and as per the investigator's decision).
Vasomotion will be assessed angiographically with Acetylcholine followed by Nitroglycerine at 12 months follow up in a subgroup of subjects, upon the investigators discretion and if subject consents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium ScaffoldAll subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 60 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is > 18 years and < 80 years of age
- Written subject informed consent available prior to PCI
- Subject eligible for PCI
- Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions and can be covered with 1 device each
- Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used
Key exclusion criteria (21 listed)
- Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- 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.
- Left main coronary artery disease
- Three-vessels with coronary artery disease requiring treatment at time of procedure
- Planned interventional treatment of any non-target vessel within 12-month post-procedure
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 |
|---|---|---|
| Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium ScaffoldSubjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold | Device | Treatment |
Primary outcome
In scaffold late lumen loss
Time frame: At 6 months after index procedure
Independent Core Lab Assessment
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 22 Jul 2022.
- Derived from this study: PubMed 40091374Aytekin A, Seguchi M, Xhepa E, Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Garcia-Garcia HM, Waksman R, Joner M. The Impact of Underlying Plaque Characteristics Following the Third-Generation Resorbable Magnesium Scaffold Implantation: An Intravascular OCT Assessment up to 12-Months. Catheter Cardiovasc Interv. 2025 Jun;105(7):1563-1571. doi: 10.1002/ccd.31486. Epub 2025 Mar 16.
- Derived from this study: PubMed 37334655Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth GG, Joner M, Toelg R, Wiemer M, Olivecrano G, Vermeersch P, Garcia-Garcia HM, Waksman R. A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study. EuroIntervention. 2023 Aug 7;19(5):e414-e422. doi: 10.4244/EIJ-D-23-00326.
- Derived from this study: PubMed 37113674Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth G, Joner M, Toelg R, Wiemer M, Olivecrona G, Vermeersch P, Garcia-Garcia HM, Waksman R. Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study. EClinicalMedicine. 2023 Apr 17;59:101940. doi: 10.1016/j.eclinm.2023.101940. eCollection 2023 May.
- Individual participant dataSharing planned: No
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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.
Michael Haude, Prof principal investigator
Rheinland Klinikum Lukaskrankenhaus Neuss
14 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in people with Coronary Artery Disease, run by Biotronik AG at 14 sites in 8 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 9 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Belgium, Austria, Netherlands, Poland and 3 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?
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?
In scaffold late lumen loss (time frame: At 6 months after index procedure). 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 NCT04157153, which also lists 3 linked publications.
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 22 Jul 2022.