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Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System

NCT05540223 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1859

Last updated 2025-11-21

No results posted yet for this study

Summary

The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).

Conditions

  • Coronary Artery Disease
  • Atherosclerosis, Coronary
  • Myocardial Ischemia
  • Ischemic Heart Disease
  • Acute Coronary Syndrome
  • Angina Pectoris

Interventions

DEVICE

Freesolve RMS

Subject undergoes implantation of Freesolve RMS

DEVICE

Xience DES

Subject undergoes implantation of Xience DES

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Michael Haude, MD · Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-13
Primary Completion
2027-02-28
Completion
2032-02-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05540223 on ClinicalTrials.gov