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

Coronary Artery Disease Clinical Trial

— BIOSOLVE-IV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02817802
• Other study ID #: C1503
• Status: Active, not recruiting
• Start date: August 2016
• Est. completion date: October 2025

Study information

• Verified date: February 2023
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2066
• Est. completion date: October 2025
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion cirteria

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Magmaris
PCI (Magmaris)

Locations

Country	Name	City	State
Belgium	ZNA Middelheim Cardiologiy	Antwerpen
Hong Kong	Queen Elizabeth Hospital	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Belgium,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF)* at 12 months		12 month

External Links

•   Primary end point of the study