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Safety and Performance Study of Large Hole Vascular Closure Device - France

NCT05323877 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-04-12

No results posted yet for this study

Summary

This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 20 patients in 2 centres within France. 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 - 22 F sheaths (arteriotomy up to 26 F).

Conditions

  • Large Hole Percutaneous Arterial Closure

Interventions

DEVICE

Test Device (PerQseal+)

Percutaneous arterial closure device

Sponsors & Collaborators

  • Vivasure Medical Limited

    lead INDUSTRY

Principal Investigators

  • Lionel Leroux, MD · University Hospital, Bordeaux

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-08-31
Completion
2023-04-30

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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 NCT05323877 on ClinicalTrials.gov