NCT04818541: An overdue trial by Vivasure Medical Limited
This trial is overdue. It was due to report 1 year, 2 months ago.
Think we've made a mistake? Before contacting us, review the criteria in our paper. In particular, bear in mind the following:
- We can only rely on the structured data that sponsors put into the registry: they may enter incorrect or incomplete data.
- Reporting in a journal is not enough. The FDAAA rules state that the trial must be reported on ClinicalTrials.gov.
- Terminated trials are required to report results. Only withdrawn trials (which never recruited a single patient) are not.
Full data
| Full entry on ClinicalTrials.gov | NCT04818541 |
|---|---|
| Title | Early Feasibility Study of the Vivasure PerQseal® Closure Device System After Use of the Impella Device for Cardiogenic Shock or Protected Percutaneous Coronary Intervention |
| Results Status | Overdue |
| ACT or pACT? | This is what FDAAA officially calls an "Applicable Clinical Trial" |
| Start date | June 29, 2021 |
| Completion date | Jan. 1, 2023 |
| Required reporting date | Jan. 1, 2024, midnight |
| Actual reporting date | None |
| Date last checked at ClinicalTrials.gov | Feb. 9, 2024 |
| Days late | 39 |