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
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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