Trials / Terminated
TerminatedNCT04375085
DESyne X2 Post Market Follow-up Study
A Non-Randomized, Post Marketing Clinical Follow-Up (PMCF) Study of the DESyne X2 Novolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Elixir Medical Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A single-arm post-market clinical follow-up study to confirm that the DESyne X2 delivery system performs similarly to the DESyne delivery system.
Detailed description
A single-arm post-market follow up study (PMCF) comparing the DESyne X2 PMCF data to the historic DESyne acute performance data to confirm the performance of the DESyne X2 Novolimus Eluting Coronary Stent System with regards to the residual risks of lesion access and acute device implantation through visually-assessed angiographic endpoints and physician feedback.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous Coronary Intervention | Percutaneous Coronary Intervention |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-12-28
- Completion
- 2021-12-28
- First posted
- 2020-05-05
- Last updated
- 2023-10-25
- Results posted
- 2023-10-25
Locations
3 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04375085. Inclusion in this directory is not an endorsement.