Resorbable Magnesium Scaffolds Registry

NCT04679740 · tracked via the Priya Life Science Poland tracker

Sponsor

Biotronik AG

Phase

Observational

Started

2020-11-18

Last updated

2025-11-21

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

MagmarisFreesolve

Magmaris: MAGMARIS is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length.

Freesolve: Freesolve is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length.

Study summary

The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * According to the IFU Exclusion Criteria: * According to the IFU

Primary outcome measure(s)

Target Lesion Failure (TLF) — 12 months
The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR).

Trial sites (13)

Facility	City	Region	Status
Cairns Hospital	Cairns	Australia	Completed
Heart Center Segeberger Kliniken	Bad Segeberg	Germany	Recruiting
Krankenhaus Buchholz	Buchholz	Germany	Completed
Klinikum Westfalen, Knappschaft KH	Dortmund	Germany	Completed
Klinikum Herford	Herford	Germany	Completed
Herz-und Gefäßzentrum Oberallgäu-Kempten	Kempten	Germany	Completed
Centro Cardiologico Monzino	Milan	Lombardy	Recruiting
Daugavpils Regional Hospital	Daugavpils	Latvia	Completed
1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie	Lublin	Poland	Recruiting
SUSCCH Banska Bystrica	Banská Bystrica	Slovakia	Completed
Lindenhofspital	Bern	Switzerland	Recruiting
Centre Hospitalier Universitaire Vaudois	Lausanne	Switzerland	Recruiting
Solothurner Spitäler AG	Olten	Switzerland	Recruiting

More Biotronik AG trials in Poland

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions Recruiting

First in Men Study: BIOMAG-I Active, not recruiting

Other trials for the same condition

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions Recruiting

COronoary Microcirculation Analysis NETwork Recruiting

Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting Enrolling by invitation

INSIGHTFUL-FFR Clinical Trial Recruiting

First in Men Study: BIOMAG-I Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04679740 on ClinicalTrials.gov ↗ ← All trials in Poland