RecruitingNot ApplicableNCT07091682

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

BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable MAGnesium Scaffold (Freesolve) in the Treatment of Subjects With Long de Novo Lesions in Native Coronary Arteries: BIOMAG-LL

Sponsor

Biotronik AG

Enrollment

100 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

Myocardial Ischemia Coronary Artery Disease Ischemic Heart Disease Angina Pectoris Acute Coronary Syndromes Atherosclerosis of Coronary Artery

Summary

The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold for people with acute coronary syndromes, angina pectoris, and other related conditions. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold

Locations(14)

Katholisches Krankenhaus "St. Johann Nepomuk"

Erfurt, Germany

Universitätsklinikum Halle (Saale)

Halle, Germany

Klinikverbund Allgäu gGmbH

Immenstadt and Kempten, Germany

Klinikum der Ludwig-Maximilians-Universität München

München, Germany

Semmelweis University

Budapest, Hungary

Centro Cardiologico Monzino SpA

Milan, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Pauls Stradins Clinical University Hospital

Riga, Latvia

Miedziowe Centrum Zdrowia S.A

Lubin, Poland

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital de la Princesa

Madrid, Spain

Hospital Clinic Universitario de Valladolid

Valladolid, Spain

University Hospital Basel

Basel, Switzerland

HUG Hospitaux Universitaires de Geneve

Geneva, Switzerland

View Full Details on ClinicalTrials.gov

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NCT07091682

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