NCT04034121

Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry

Non-randomized Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System in de Novo Native Coronary Artery Lesions - DESolve Cx Single-Arm Registry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Elixir Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This additional arm of the DESolve Nx study is an evaluation of the CE Mark approved DESolve Cx Novolimus Eluting Bioresorbable Scaffold System.

Detailed description

The DESolve Cx Single-Arm Registry enrolled patients using the same inclusion and exclusion criteria and clinical endpoints as the DESolve Nx Study This study was split into 2 cohorts - European and Brazilian. The European cohort (30 subjects) completed all follow-up at 1 year and the Brazilian cohort at 3 years (20 subjects)

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	DESolve Cx drug eluting coronary scaffold system	percutaneous coronary intervention

Timeline

• Start date: 2016-01-20
• Primary completion: 2017-01-22
• Completion: 2020-09-30
• First posted: 2019-07-26
• Last updated: 2021-07-14
• Results posted: 2021-07-14

Locations

3 sites across 2 countries: Belgium, Brazil

Regulatory

• FDA-regulated device study