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The Ladera Suture-Mediated Large Bore Closure Study | Clinical Trials | Clareo Health

RECRUITINGNA

The Ladera Suture-Mediated Large Bore Closure Study

A Prospective, Multi-Center, Single-Arm Study to Evaluate the Safety and Performance of the Ladera Medical Suture-Mediated Closure System When Used to Achieve Hemostasis of Common Femoral Arteriotomies in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures (the FASTEN Study)

NCT06851481•Ladera Medical

View on ClinicalTrials.gov

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.

Detailed Description

The Ladera Medical suture mediated large bore closure (LBC) system is a vascular closure device intended for use in catheterization laboratories following percutaneous interventional catheterization procedures that use the retrograde common femoral artery access route for large bore interventional devices. The function of Ladera LBC System is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and performance of the LBC System in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous interventional catheterization procedures using a large-bore procedure sheath.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient is ≥ 18 years old
•2. Patient is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous interventional catheterization procedures involving access through the common femoral artery using 10 to 24 Fr introducer sheaths (i.e., BAV, TAVR/TAVI, PEVAR, TEVAR)
•3. Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
•4. Patient is willing and able to complete follow-up requirements
•5. Patient has the mental capacity to consent for themselves (i.e., does not require the use of a Legally Authorized Representative), and signs a written Informed Consent Form (ICF) prior participating in the study

Exclusion Criteria

•Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met:
•Screening / Baseline
•1. Prior intra-aortic balloon pump at access site within 30 days of baseline evaluation
•2. Patients with severe inflow disease (iliac artery diameter stenosis \> 50%) and/or severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed with prior standard of care Computed Tomography (CT) Imaging
•3. Common femoral artery and iliac lumen diameter is \< 6 mm as confirmed with prior standard of care CT Imaging
•4. Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging
•5. Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior CT Imaging
•6. In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
•7. Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
•8. Prior atherectomy, vascular surgery, vascular graft, or stent in region of access site
+37 more criteria

Locations (6)

Jessie McPherson Private Hospital

Clayton, Clayton VIC, Australia

Macquarie University

Sydney, New South Wales, Australia

Monash Health, Victoria Heart Hospital

Melbourne, Victoria, Australia

AZ Sint-Jan Brugge AV

Bruges, Belgium

OLVG Amsterdam

Amsterdam, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

Key Dates

Start Date

August 18, 2025

Primary Completion Date

December 30, 2025

Completion Date

December 31, 2025

Last Updated

December 15, 2025

Enrollment

ESTIMATED participants

Conditions

Vascular ClosureFemoral Arteriotomy Closure

Interventions

Ladera LBC System

DEVICE

Contacts

Sarah L Canio

CONTACT

408-316-5575 sarah.canio@laderamedical.com

Keri Y Ng

CONTACT

keri@inventure.group

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Ladera Suture-Mediated Large Bore Closure Study

Inclusion Criteria

Exclusion Criteria

The Ladera Large Bore Closure Feasibility Study

Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System

Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture

PerQseal® Impella Early Feasibility Study

Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device

X-Seal EU Post-Market Clinical Follow-Up Protocol