Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Vivasure Medical Limited.
NCT04818541 is a NA study that has completed, run by Vivasure Medical Limited. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary safety endpoint is the rate of major access site complications attributable to the PerQseal® device. As per FDA definitions for Major access site complications.
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 |
What the finished NCT04818541 record still lists
NCT04818541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which PPCI is the first listed.
NCT04818541 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04818541's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03207464 · 19 participants · Phase 1
Molecular Imaging of NET Using [C-11]MRB-PET in MS
- NCT04318717 · 19 participants · Phase 2
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
- NCT05103904 · 19 participants · Phase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
- NCT05607407 · 19 participants · Phase 2
Methimazole in Patients With Progressive Glioblastoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI