Clinical trial NCT02817802: BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
Official title: BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: Registry
Magmaris
Coronary Artery Disease
PCI
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 2066
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target Lesion Failure (TLF)* at 12 months
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim Cardiologiy
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Cardiovascular Institute Middelheim, Antwerpen, Belgium
name: Stefan Verheye, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Elizabeth Hospital, Hong Kong
name: Michael Kang-Yin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: