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The Ladera Large Bore Closure Feasibility Study

NCT06358157 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-17

No results posted yet for this study

Summary

This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a large-bore procedure sheath.

Conditions

  • Vascular Closure
  • Femoral Arteriotomy Closure

Interventions

DEVICE

Ladera LBC System

Use of the Ladera LBC System to close the femoral arteriotomy

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Ladera Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • Australia

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 NCT06358157 on ClinicalTrials.gov