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NCT04818541 · ClinicalTrials.gov registry record · NA
PerQseal® Impella Early Feasibility Study
A NA study, sponsored by Vivasure Medical Limited.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT04818541 is a NA study that has completed, run by Vivasure Medical Limited. The registered enrollment target is 19 participants.
The verdict
NCT04818541, a NA study, has completed, sponsored by Vivasure Medical Limited.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this Clinical Investigation Plan is to assess the initial feasibility results of the PerQseal® device, when used on this very specific Impella population. Safety and effectiveness will be assessed in patients where an Impella device was used for either cardiogenic shock or PPCI. Closure of femoral arterial access sites created with 13 to 14 F sheaths will be studied, assessing the need for alternative therapy other than manual compression or adjunctive endovascular ballooning.
Interventions
- DEVICE PPCI
- DEVICE Cardiogenic shock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2023-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04818541
The ClinicalTrials.gov registry entry for NCT04818541 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vivasure Medical Limited, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PPCI is the first listed.
NCT04818541 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04818541 about?
NCT04818541 is a clinical study titled "PerQseal® Impella Early Feasibility Study". The purpose of this Clinical Investigation Plan is to assess the initial feasibility results of the PerQseal® device, when used on this very specific Impella population. Safety and effectiveness will be assessed in patients where an Impella device was used for either cardiogenic shock or PPCI. Closu...
What is the current status of trial NCT04818541?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2021-06-29. Estimated completion is 2023-03-01.
What interventions are being tested in trial NCT04818541?
The interventions under investigation include: PPCI (DEVICE), Cardiogenic shock (DEVICE).
Who is sponsoring clinical trial NCT04818541?
This trial is sponsored by Vivasure Medical Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
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