Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-21 @ 9:04 AM
Study NCT ID:
NCT02817802
Status:
UNKNOWN
Last Update Posted:
2023-02-10
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
Sponsor:
Biotronik AG
Organization:
Study Overview
Official Title:
BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOSOLVE-IV
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.
The aim of this observational registry is to investigate the clinical performance and long-term safety of Magmaris in a real world setting.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: