BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV

NCT ID: NCT02817802

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2066 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2025-10-31

Brief Summary

The registry will investigate the clinical performance and long-term safety of Magmaris in a real world setting

Detailed Description

Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy.Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.

The aim of this observational registry is to investigate the clinical performance and long-term safety of Magmaris in a real world setting.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Magmaris

Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Magmaris

Intervention Type: DEVICE

PCI (Magmaris)

Interventions

Magmaris

PCI (Magmaris)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is ≥18 years of Age

2. Subject must be willing to sign a Patient Informed Consent (PIC) or Patient Data Release Form (PDRF) where applicable

3. Symptomatic coronary artery disease

4. Subject with a maximum of two single de novo lesions in two different major epicardial vessels

5. Target lesion length ≤21 mm by QCA or by visual estimation

6. Target lesion stenosis by visual estimation: >50% - <100% and TIMI flow ≥1

7. Subject is eligible for Dual Anti Platelet Therapy (DAPT)

8. Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used

Exclusion Criteria

1. Pregnant and/or breast feeding females or females who intend to become pregnant during the time of the registry

2. Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, heparin or any other anticoagulant/antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs; or the scaffold materials including Magnesium, Yttrium, Neodymium, Zirconium,Gadolinium, Dysprosium, Tantalum that cannot beadequately pre-medicated

3. Subjects on dialysis

4. 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. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment

5. Documented left ventricular ejection fraction (LVEF) <30%

6. Restenotic target lesion

7. Thrombus in target vessel

8. Target lesion is located in or supplied by a diseased (defined as vessel irregularity per angiogram and >20% stenosed lesion by visual estimation) arterial or venous bypass graft

9. Left main coronary artery disease

10. Ostial target lesion (within 5.0 mm of vessel origin)

11. Target lesion involves a side branch ≥2.0 mm in Diameter

12. Target vessel (including side branches) has second lesion which requires treatment according to the investigator's discretion

13. Unsuccessful pre-dilatation, defined as residual Stenosis rate more than 20% measured by QCA and / or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)

14. Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained

15. Currently participating in another study and Primary endpoint is not reached yet.

16. Planned interventional treatment of any target or nontarget vessel

Participating Countries

Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Malaysia, New Zealand, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, United Kingdom

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

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Verheye, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute Middelheim, Antwerpen, Belgium

Michael Kang-Yin Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Hospital, Hong Kong

Locations

ZNA Middelheim Cardiologiy

Antwerp, , Belgium

Queen Elizabeth Hospital

Kowloon, , Hong Kong

Countries

Belgium; Hong Kong

Related Links

https://pubmed.ncbi.nlm.nih.gov/32881396/

Primary end point of the study

Other Identifiers

C1503

Identifier Type: -

Identifier Source: org_study_id