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The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de Novo Native Coronary Artery Lesions

NCT05033964 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-27

No results posted yet for this study

Summary

The objective of this clinical trial is to confirm the safety, effectiveness and performance of the DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS) (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native coronary artery lesions.

Conditions

Interventions

COMBINATION_PRODUCT

Percutaneous Coronary Intervention with drug eluting stents

Coronary drug eluting stent implantation

Sponsors & Collaborators

  • Elixir Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Stefan Verheye, MD, PHD · Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp, Belgium

  • Mark Webster, MBChB · Auckland City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2022-12-02
Completion
2026-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Belgium
  • Brazil
  • Czechia
  • Netherlands
  • New Zealand

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 NCT05033964 on ClinicalTrials.gov