drugset / Trial / NCT05033964
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
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2021-12-15
- Primary completion
- 2022-12-02
- Completion
- 2026-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Argatroban | Small molecule | — | Other |
| Subject | Novolimus | Unknown | — | — |
| Subject | Rivaroxaban | Other / unclassified | — | Other |
| Subject | Sirolimus | Small molecule | — | Other |