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First in Men Study: BIOMAG-I

NCT04157153 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2022-07-22

No results posted yet for this study

Summary

A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.

Conditions

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

  • Michael Haude, Prof · Rheinland Klinikum Lukaskrankenhaus Neuss

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
2020-04-27
Primary Completion
2022-08-31
Completion
2027-02-28

Countries

  • Austria
  • Belgium
  • Germany
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • Switzerland

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 NCT04157153 on ClinicalTrials.gov