NCT04025788

BIOSOLVE-IV Magmaris Swiss Satellite Registry

BIOTRONIKS-Safety and Performance in de Novo Lesion of Native Coronary Arteries With Magmaris (BIOSOLVE)-IV Magmaris Swiss Satellite Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

BIOSOLVE-IV Magmaris Swiss Satellite Registry is a prospective, single-arm, multicenter, nationwide open label registry. It is planned to enroll 200 subjects in up to 12 participating sites in Switzerland. After percutaneous coronary intervention (PCI) with the Magmaris scaffold and signature of the informed consent form, all subjects will be followed through hospital discharge and will undergo follow up evaluations at 6, 12 and 24 months post procedure. The follow up evaluations, part of the standard care can be either performed on site (12 months) or by phone (6 and 24 months) and according to routine clinical practice.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Magmaris Resorbable Magnesium Scaffold (RMS)	Subjects will undergo a percutaneous coronary intervention for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of two single de novo lesions in two separate major epicardial vessels are allowed.

Timeline

• Start date: 2019-03-26
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2019-07-19
• Last updated: 2022-08-02

Locations

6 sites across 1 country: Switzerland

Regulatory

• FDA-regulated device study