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PerQseal® Clinical Study

NCT05653336 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2025-01-28

No results posted yet for this study

Summary

The objective is to evaluate the safety and effectiveness of the PerQseal vascular closure device system when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing percutaneous catheter-based interventional procedures.

Conditions

  • Percutaneous Large Hole Vascular Closure

Interventions

DEVICE

PerQseal® Closure Device System

Bioabsorbable implant delivered percutaneously to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing percutaneous catheter-based interventional procedures.

Sponsors & Collaborators

  • Vivasure Medical Limited

    lead INDUSTRY

Principal Investigators

  • William Gray, Dr. · Lankenau heart Institute

  • Sean Lyden, Dr. · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2024-12-16
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States
  • Germany

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 NCT05653336 on ClinicalTrials.gov