BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Magmaris
- Registration Number
- NCT02817802
- Lead Sponsor
- Biotronik AG
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2066
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Magmaris Magmaris Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Primary Outcome Measures
Name Time Method Target Lesion Failure (TLF)* at 12 months 12 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
ZNA Middelheim Cardiologiy
🇧🇪Antwerpen, Belgium
Queen Elizabeth Hospital
ðŸ‡ðŸ‡°Kowloon, Hong Kong