First in Men Study: BIOMAG-I

NCT ID: NCT04157153

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2027-02-28

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 60 months.

Group Type: EXPERIMENTAL

Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Intervention Type: DEVICE

Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Haude, Prof

Role: PRINCIPAL_INVESTIGATOR

Rheinland Klinikum Lukaskrankenhaus Neuss

Locations

Medizinische Universität Graz

Graz, , Austria

Algemeen Ziekenhuis Middelheim

Antwerp, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

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

Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)

Amsterdam, , Netherlands

Miedziowe Centrum Zdrowia SA

Lubin, , Poland

Hospital Clinico San Carlos

Madrid, , Spain

Lund University Hospital

Lund, , Sweden

University Hospital Geneva HUG

Geneva, , Switzerland

Countries

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

References

Aytekin A, Seguchi M, Xhepa E, Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Garcia-Garcia HM, Waksman R, Joner M. The Impact of Underlying Plaque Characteristics Following the Third-Generation Resorbable Magnesium Scaffold Implantation: An Intravascular OCT Assessment up to 12-Months. Catheter Cardiovasc Interv. 2025 Jun;105(7):1563-1571. doi: 10.1002/ccd.31486. Epub 2025 Mar 16.

Reference Type: DERIVED

PMID: 40091374 (View on PubMed)

Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth GG, Joner M, Toelg R, Wiemer M, Olivecrano G, Vermeersch P, Garcia-Garcia HM, Waksman R. A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study. EuroIntervention. 2023 Aug 7;19(5):e414-e422. doi: 10.4244/EIJ-D-23-00326.

Reference Type: DERIVED

PMID: 37334655 (View on PubMed)

Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth G, Joner M, Toelg R, Wiemer M, Olivecrona G, Vermeersch P, Garcia-Garcia HM, Waksman R. Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study. EClinicalMedicine. 2023 Apr 17;59:101940. doi: 10.1016/j.eclinm.2023.101940. eCollection 2023 May.

Reference Type: DERIVED

PMID: 37113674 (View on PubMed)

Other Identifiers

C1702

Identifier Type: -

Identifier Source: org_study_id