First in Men Study: BIOMAG-I

• ClinicalTrials.gov Identifier: NCT04157153
• Recruitment Status: Active, not recruiting
• First Posted: November 8, 2019
• Last Update Posted: July 22, 2022
• Sponsor: Biotronik AG
• Information provided by (Responsible Party): Biotronik AG

Study Description

Brief Summary:

A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 116 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 27, 2020
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: February 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 60 months.	Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold; Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold

Outcome Measures

Primary Outcome Measures :

1. In scaffold late lumen loss [ Time Frame: At 6 months after index procedure ]
   Independent Core Lab Assessment

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Austria

Medizinische Universität Graz

Graz, Austria

Belgium

Algemeen Ziekenhuis Middelheim

Antwerp, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

Germany

Segeberger Kliniken

Bad Segeberg, Germany

Herz-und Gefäßzentrum Oberallgäu-Kempten

Kempten, Germany

Johannes Wesling Klinikum Minden

Minden, Germany

Deutsches Herzzentrum

Münich, Germany

Rheinland Klinikum Lukaskrankenhaus Neuss

Neuss, Germany

Netherlands

Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)

Amsterdam, Netherlands

Poland

Miedziowe Centrum Zdrowia SA

Lubin, Poland

Spain

Hospital Clinico San Carlos

Madrid, Spain

Sweden

Lund University Hospital

Lund, Sweden

Switzerland

University Hospital Geneva HUG

Geneva, Switzerland

Sponsors and Collaborators

Biotronik AG

Investigators

• Principal Investigator: Michael Haude, Prof; Rheinland Klinikum Lukaskrankenhaus Neuss

More Information

• Responsible Party: Biotronik AG
• ClinicalTrials.gov Identifier: NCT04157153
• Other Study ID Numbers: C1702
• First Posted: November 8, 2019
• Last Update Posted: July 22, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Sirolimus; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs