First in Men Study: BIOMAG-I

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

• Registration Number: NCT04157153
• Lead Sponsor: Biotronik AG

Brief Summary

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 Timeline

• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-08
• Study Start: 2020-04-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-22
• Primary Completion: 2022-08
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. Subject is > 18 years and < 80 years of age
2. Written subject informed consent available prior to PCI
3. Subject eligible for PCI
4. 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
5. Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used
6. Target lesion length ≤ 28 mm by visual estimation, depending on the scaffold size used
7. Target lesion stenosis by visual estimation > 50% - < 100% and TIMI flow ≥1 (assisted by e.g. QCA / IVUS /FFR).
8. Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients without angiographic evidence of thrombus at target lesion
9. Eligible for Dual Anti Platelet Therapy (DAPT)

Exclusion Criteria

1. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
2. 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.
3. Left main coronary artery disease
4. Three-vessels with coronary artery disease requiring treatment at time of procedure
5. Planned interventional treatment of any non-target vessel within 12-month post-procedure
6. Subjects on dialysis
7. Planned intervention of the target vessel post index procedure
8. Ostial target lesion (within 5.0 mm of vessel origin)
9. Target lesion involves a side branch >2.0 mm in diameter
10. Documented left ventricular ejection fraction (LVEF) ≤ 30% within the last 6 months
11. Heavily calcified lesion
12. Target lesion is located in or supplied by an arterial or venous bypass graft
13. 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.)
14. 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)
15. Known allergies to: Acetylsalicylic Acid (ASA), P2Y12 inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
16. 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)
17. A stenosis located proximal or distal to the target lesion that might require future revascularization or an impede run off detected during diagnostic angiography
18. Life expectancy less than 1 year
19. Planned surgery or dental surgical procedure within 6 months after index procedure unless DAPT will be maintained
20. In the investigators opinion, subject will not be able to comply with the follow-up requirements
21. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold	All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 60 months.

Primary Outcome Measures

Name	Time	Method
In scaffold late lumen loss	At 6 months after index procedure	Independent Core Lab Assessment

Trial Locations

Locations (14)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany

Herz-und Gefäßzentrum Oberallgäu-Kempten; 🇩🇪 Kempten, Germany

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Belgium

Rheinland Klinikum Lukaskrankenhaus Neuss; 🇩🇪 Neuss, Germany

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerp, Belgium

Miedziowe Centrum Zdrowia SA; 🇵🇱 Lubin, Poland

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

Deutsches Herzzentrum; 🇩🇪 Münich, Germany

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG); 🇳🇱 Amsterdam, Netherlands

Lund University Hospital; 🇸🇪 Lund, Sweden

University Hospital Geneva HUG; 🇨🇭 Geneva, Switzerland

Medizinische Universität Graz; 🇦🇹 Graz, Austria