New Stitch-Device aims to seal artery holes after heart procedures

NCT ID NCT06851481

Completed Disease control Sponsor: Ladera Medical Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study is testing a new device called the Ladera LBC System that uses stitches to close the hole in the femoral artery after catheter-based heart or blood vessel procedures. The study will enroll 55 adults who are scheduled for elective procedures using large sheaths (10 to 24 French). The main goals are to see if the device stops bleeding quickly and safely, with no major complications within 30 days.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Ladera LBC System (a suture-based device to close the artery)
What this could lead to: If it works, this device could offer a faster, safer way to close the femoral artery after heart or blood vessel procedures, reducing complications.
What could go wrong: This is a small, early study with only 55 people and no comparison group. The device may not work as well as existing methods, and there is a risk of bleeding or other access-site problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

vascular occlusion disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FEMORAL ARTERIOTOMY CLOSURE VASCULAR CLOSURE

Contacts and locations

Locations

AZ Sint-Jan Brugge AV

Bruges, Belgium
Erasmus University Medical Center

Rotterdam, Netherlands
Jessie McPherson Private Hospital

Clayton, Clayton VIC, 3168, Australia
Macquarie University

Sydney, New South Wales, Australia
Monash Health, Victoria Heart Hospital

Melbourne, Victoria, Australia
OLVG Amsterdam

Amsterdam, Netherlands

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