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

NCT07258290 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1859

Last updated 2025-12-02

No results posted yet for this study

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

Conditions

  • Coronary Disease
  • Heart Diseases
  • Cardiovascular Diseases
  • Arteriosclerosis
  • Arterial Occlusive Diseases
  • Vascular Diseases
  • Chest Pain
  • Pain
  • Neurologic Manifestations
  • Signs and Symptoms
  • Pathological Conditions, Signs and Symptoms
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Acute Coronary Syndrome
  • Angina Pectoris

Interventions

DEVICE

Freesolve RMS

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

DEVICE

Xience DES

Xience Everolimus Eluting Stent System

Sponsors & Collaborators

  • Teleflex

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-06-30
Completion
2033-06-30
FDA Device
Yes

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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 NCT07258290 on ClinicalTrials.gov