The Ladera Suture-Mediated Large Bore Closure Pivotal Study
NCT07541235 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214
Last updated 2026-04-21
Summary
The study objective is to demonstrate the safety and efficacy of the investigational device to achieve hemostasis of common femoral artery access sites in participants undergoing percutaneous interventional catheterization procedures utilizing 10 to 24 Fr introducer sheaths.
Conditions
- Vascular Closure Device
Interventions
- DEVICE
-
Ladera LBC System
Use of the Ladera LBC System to close the femoral arteriotomy
Sponsors & Collaborators
-
Ladera Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2027-08-31
- Completion
- 2027-10-31
Countries
- Australia
Study Locations
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