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

NCT07091682 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-21

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Implantation 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

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Flavio Luciano Ribichini, Prof. Dr. · Azienda Ospedaliera Universitaria Integrata Verona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-02-18
Primary Completion
2027-06-30
Completion
2031-06-30

Countries

  • Germany
  • Italy
  • Latvia
  • Poland
  • Spain

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 NCT07091682 on ClinicalTrials.gov