RecruitingNot ApplicableNCT07258290

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions

Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries


Sponsor

Teleflex

Enrollment

1,859 participants

Start Date

Jun 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Freesolve RMS and a medical device called Xience DES for people with acute coronary syndrome, angina pectoris, and other related conditions. The study is currently recruiting participants at 1 location. 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

DEVICEFreesolve RMS

Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System, a drug-eluting balloon-expandable resorbable scaffold

DEVICEXience DES

Xience Everolimus Eluting Stent System


Locations(2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07258290


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