First in Men Study: BIOMAG-I

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04157153
• Other study ID #: C1702
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: February 2027

Study information

• Verified date: July 2022
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: February 2027
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	UZ Leuven Gasthuisberg	Leuven
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
Netherlands	Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)	Amsterdam
Poland	Miedziowe Centrum Zdrowia SA	Lubin
Spain	Hospital Clinico San Carlos	Madrid
Sweden	Lund University Hospital	Lund
Switzerland	University Hospital Geneva HUG	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In scaffold late lumen loss	Independent Core Lab Assessment	At 6 months after index procedure