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Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients

NCT03842813 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1030

Last updated 2021-05-10

No results posted yet for this study

Summary

The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients.

As routine care, each patient will be followed until 12 months after stent implantation.

Conditions

Interventions

DEVICE

DES-CRE8

Polymer-free Amphilimus™ (Sirolimus + Fatty Acid) eluting coronary stent. The absence of the polymer minimizes the risk of inflammation/thrombosis, while the propriety formulation enhances drug absorption.

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • Alvimedica Medical Technologies France

    lead INDUSTRY

Principal Investigators

  • Julien Vandenwildenberg · Alvimedica Medical France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2022-02-28
Completion
2022-07-31

Countries

  • France

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 NCT03842813 on ClinicalTrials.gov