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PerQseal® Impella Early Feasibility Study

NCT04818541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-04-26

No results posted yet for this 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.

Conditions

  • Percutaneous Large Hole Vascular Closure

Interventions

DEVICE

PPCI

Closure of the femoral access site with PerQseal device at the end of the PPCI index procedure and removal of the Impella pump.

DEVICE

Cardiogenic shock

Closure of the femoral access site with PerQseal device after removal of the Impella pump.

Sponsors & Collaborators

  • Vivasure Medical Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2023-01-01
Completion
2023-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04818541 on ClinicalTrials.gov