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NCT05653336 · ClinicalTrials.gov registry record · NA

PerQseal® Clinical Study

A NA study of Percutaneous Large Hole Vascular Closure, sponsored by Vivasure Medical Limited.

Active
Registry status
NA
Development phase
149
Enrollment target
18
Study locations

NCT05653336: Active NA study of Percutaneous Large Hole Vascular Closure, sponsored by Vivasure Medical Limited.

NCT05653336 is a NA study of Percutaneous Large Hole Vascular Closure that is active but no longer recruiting, run by Vivasure Medical Limited. The registered enrollment target is 149 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05653336, a NA study of Percutaneous Large Hole Vascular Closure, is active but no longer recruiting, sponsored by Vivasure Medical Limited.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
149 participants
Enrollment target
18
Study locations

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.

Primary Outcome

Rate of major access site complications attributable to the PerQseal device

Interventions

  • DEVICE PerQseal® Closure Device System

Study Locations (18)

New York

  • University of Buffalo - Buffalo
  • Columbia University Medical Center/ NewYork Presbyterian Hospital - New York
  • University of Rochester Medical Center - Rochester
  • Stony Brook University Hospital - Stony Brook
  • Montefiore Medical Center (multiple centers) - The Bronx

Pennsylvania

  • UPMC Pinnacle Health - Mechanicsburg
  • UPenn - Perelman Center for Advanced Medicine, - Philadelphia
  • Lankenau Institute for Medical Research - Wynnewood

New Jersey

  • Cooper University Hospital - Camden
  • The Valley Hospital - Paramus

Arizona

  • HonorHealth - Scottsdale

California

  • Scripps - La Jolla

Maine

  • Northern Light Eastern Maine Medical Center - Bangor

Ohio

  • The Cleveland Clinic - Cleveland

Texas

  • The Texas Heart Institute - Houston

Trial Details

FieldValue
Enrollment Target 149 participants
Start Date 2023-03-30
Est. Completion 2025-06
Phase NA
Vivasure Medical Limited

3 total trials

What the registry record for NCT05653336 still lists

NCT05653336 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Percutaneous Large Hole Vascular Closure appearing as the primary indexed condition, and to 1 intervention - of which PerQseal® Closure Device System is the first listed.

NCT05653336 lists 18 locations in 11 states (New York, Pennsylvania, New Jersey).

Frequently Asked Questions

What is clinical trial NCT05653336 about?

NCT05653336 is a clinical study titled "PerQseal® Clinical Study". 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 procedure...

What is the current status of trial NCT05653336?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 149 participants. The study started on 2023-03-30. Estimated completion is 2025-06.

What conditions does trial NCT05653336 study?

This clinical trial studies the following conditions: Percutaneous Large Hole Vascular Closure.

What interventions are being tested in trial NCT05653336?

The interventions under investigation include: PerQseal® Closure Device System (DEVICE).

Who is sponsoring clinical trial NCT05653336?

This trial is sponsored by Vivasure Medical Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05653336 being conducted?

This trial has 18 study locations across Arizona, California, Maine, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05653336's enrollment target sits among peer trials

149 702nd of 2000 higher than 1,299 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

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Source: ClinicalTrials.gov NCT05653336, the US trial registry maintained by the National Library of Medicine. NCT05653336 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.