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PerQseal® Elite Venous Clinical Study (ELITE-Venous)

NCT06007339 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-03-26

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F) in patients undergoing percutaneous catheter-based interventional procedures, with sufficient rigor to provide robust scientific evidence for the demonstration of clinical safety and efficacy of the PerQseal Elite closure system to support a CE-mark and a PMA submission.

Conditions

  • Large Hole Percutaneous Venous Closure

Interventions

DEVICE

PerQseal ELITE

The term PerQseal Elite used singularly refers to the closure system comprising the closure device and Introducer. These individually are referred to as: "PerQseal Elite VCD" or "PerQseal Elite closure device" and/or "PerQseal Elite Introducer".

Sponsors & Collaborators

  • Vivasure Medical Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • Netherlands

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 NCT06007339 on ClinicalTrials.gov