Clinical trial NCT04157153: First in Men Study: BIOMAG-I
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2019-11-08
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: In scaffold late lumen loss
timeFrame: At 6 months after index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Antwerp
country: Belgium
facility: Algemeen Ziekenhuis Middelheim
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Kempten
country: Germany
facility: Herz-und Gefäßzentrum Oberallgäu-Kempten
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Münich
country: Germany
facility: Deutsches Herzzentrum
city: Neuss
country: Germany
facility: Rheinland Klinikum Lukaskrankenhaus Neuss
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia SA
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Lund
country: Sweden
facility: Lund University Hospital
city: Geneva
country: Switzerland
facility: University Hospital Geneva HUG
Study officials:
affiliation: Rheinland Klinikum Lukaskrankenhaus Neuss
name: Michael Haude, Prof
role: PRINCIPAL_INVESTIGATOR
References: