First in Men Study: BIOMAG-I

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medizinische Universitat Graz
• Belgium
  • Antwerp, Belgium
    • Algemeen Ziekenhuis Middelheim
  • Genk, Belgium
    • Ziekenhuis Oost-Limburg
  • Leuven, Belgium
    • UZ Leuven Gasthuisberg
• Germany
  • Bad Segeberg, Germany
    • Segeberger Kliniken
  • Kempten, Germany
    • Herz-und Gefäßzentrum Oberallgäu-Kempten
  • Minden, Germany
    • Johannes Wesling Klinikum Minden
  • Münich, Germany
    • Deutsches Herzzentrum
  • Neuss, Germany
    • Rheinland Klinikum Lukaskrankenhaus Neuss
• Netherlands
  • Amsterdam, Netherlands
    • Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)
• Poland
  • Lubin, Poland
    • Miedziowe Centrum Zdrowia SA
• Spain
  • Madrid, Spain
    • Hospital Clinico San Carlos
• Sweden
  • Lund, Sweden
    • Lund University Hospital
• Switzerland
  • Geneva, Switzerland
    • University Hospital Geneva HUG

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In scaffold late lumen loss	Independent Core Lab Assessment	At 6 months after index procedure

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: Michael Haude, Prof, Rheinland Klinikum Lukaskrankenhaus Neuss

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): February 1, 2027

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: C1702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No