Trials / Unknown
UnknownNCT02817802
BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,066 (actual)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Magmaris | PCI (Magmaris) |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2020-07-14
- Completion
- 2025-10-01
- First posted
- 2016-06-29
- Last updated
- 2023-02-10
Locations
2 sites across 2 countries: Belgium, Hong Kong
Source: ClinicalTrials.gov record NCT02817802. Inclusion in this directory is not an endorsement.