Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - The DESolve Nx Trial

NCT02086045 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-09-07

No results posted yet for this study

Summary

To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native coronary artery lesion designated the target lesion and up to one non-target lesion located in a separate epicardial vessel.

Conditions

Interventions

DEVICE

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System

percutaneous coronary

Sponsors & Collaborators

  • Elixir Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Alex Abizaid, MD, PhD · Instituto Dante Pazzanese de Cardiologia

  • Stefan Verheye, MD, PhD · AZ Middelheim Hospital

  • John Ormiston, MD · Auckland City Hospital

  • Joachim Schofer, MD, PhD · Universitäres Herz- und Gefäßzentrum

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-06-30
Completion
2017-05-15

Countries

  • Belgium
  • Brazil
  • Denmark
  • Germany
  • New Zealand
  • Poland

Study Locations

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Entities

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 NCT02086045 on ClinicalTrials.gov