Resorbable Magnesium Scaffolds Registry

NCT04679740 | Recruiting

• 1 other identifier: C1908
• Study Type: observational
• Target: 1,106
• Locations: 7 countries
• Sites: 13

Brief 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).

Conditions

Coronary Artery Disease

Keywords

Registry; Magmaris; Coronary Artery Disease; PCI; Resorbable Magnesium Scaffolds; Freesolve

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)

  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).

  12 months

Interventions

Magmaris DEVICE

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.

Also known as: Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Freesolve DEVICE

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.

Also known as: Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions

You may qualify if:

• According to the IFU

You may not qualify if:

• According to the IFU

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (13)

Cairns Hospital

Cairns, 4870, Australia

COMPLETED

Heart Center Segeberger Kliniken

Bad Segeberg, 23795, Germany

RECRUITING

Krankenhaus Buchholz

Buchholz, 21244, Germany

COMPLETED

Klinikum Westfalen, Knappschaft KH

Dortmund, 44309, Germany

COMPLETED

Klinikum Herford

Herford, 32049, Germany

COMPLETED

Herz-und Gefäßzentrum Oberallgäu-Kempten

Kempten, Germany

COMPLETED

Centro Cardiologico Monzino

Milan, Lombardy, 20138, Italy

RECRUITING

Daugavpils Regional Hospital

Daugavpils, LV-5417, Latvia

COMPLETED

1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie

Lublin, Poland

RECRUITING

SUSCCH Banska Bystrica

Banská Bystrica, 974 01, Slovakia

COMPLETED

Lindenhofspital

Bern, 3001, Switzerland

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, 1005, Switzerland

RECRUITING

Solothurner Spitäler AG

Olten, 4600, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Stefano Galli, MD

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Gattiglio, Dr.

CONTACT

+41754295843; marina.gattiglio@teleflex.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: November 18, 2020
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1); CH (3); LA (1); AU (1); DE (5); IT (1); PL (1)