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Safety and Performance Study for Arterial Large Hole Vascular Closure Device

NCT05951634 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-07-19

No results posted yet for this study

Summary

To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 14 to 22 F sheaths.

Note, for reference purposes, it is expected arteriotomies created with 14 to 22 F sheaths will create an arteriotomy in the range of 16 - 26 F (being the outer diameter of these sheaths).

Conditions

  • Large Hole Percutaneous Arterial Closure

Interventions

DEVICE

PerQseal ELITE

Percutaneous ELITE Arterial Closure Device 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
2023-08-31
Primary Completion
2024-09-30
Completion
2025-09-30

More Related Trials

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 NCT05951634 on ClinicalTrials.gov