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The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries

NCT04192747 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 445

Last updated 2025-03-24

Study results available
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Summary

The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions

Conditions

Interventions

DEVICE

Percutaneous Coronary Intervention

Percutaneous coronary intervention of de novo native coronary artery lesions

Sponsors & Collaborators

  • Elixir Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Shigeru Saito, MD · Chief Director, Shonan Kamakura General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2023-02-28
Completion
2027-02-28
FDA Device
Yes

Countries

  • Belgium
  • Germany
  • Japan
  • New Zealand

Study Locations

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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 NCT04192747 on ClinicalTrials.gov