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NCT04799769

Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study

Status unknown NA Last updated 12 April 2022
What this trial tests

NA trial testing Percutaneous arterial closure device in Percutaneous Arteriotomy Closure in 90 participants. Status unknown.

Timeline
10 March 2021
Primary endpoint
10 January 2023
10 March 2023

Quick facts

Lead sponsorVivasure Medical Limited
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment90
Start date10 March 2021
Primary completion10 January 2023
Estimated completion10 March 2023
Sites5 locations across Netherlands, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Vivasure Medical Limited

Who can join

18 and older, any sex, with Percutaneous Arteriotomy Closure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites. The PerQseal® + shall be indicated for the percutaneous closure of femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created with 14 - 22F sheaths (arteriotomy up to 26 F).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Frontier V Study: Evaluating the Safety and Clinical Performance of a Large-Bore Vascular Closure Device After Femoral Arterial Access.
    Frerker C, Schwindt A, Schmidt A, Schmidt T, et al · · 2025 · cited 1× · PMID 40343429 · DOI 10.1002/ccd.31574

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Other Vivasure Medical Limited trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04799769.

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