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The Ladera Large Bore Closure Feasibility Study

Evaluation of the Safety and Performance of the Ladera Medical Suture-Mediated Large Bore Closure (LBC) System

NCT06358157•Ladera Medical

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

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 21 or older
•2. Scheduled for an elective or planned single percutaneous interventional catheterization procedure involving access through the femoral artery using a unilateral procedural sheath ID within the indicated range or device (OD) if an expandable sheath is used
•3. Willing and able to give written informed consent and to complete a follow-up visit at 30 ± 7 days

Exclusion Criteria

•Baseline
•1. Evidence of current systemic bacterial or cutaneous infection, including groin infection
•2. Known bleeding disorders including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease or known Type II heparin-induced thrombocytopenia
•3. Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants planned within 24 hours prior to primary procedure
•4. Glycoprotein IIb/IIIa inhibitors planned within 24 hours prior to the primary procedure, during the procedure, or within 48 hours after the primary procedure
•5. Planned anticoagulation therapy within 24 hours after the primary procedure such that the activated clotting time (ACT) is expected to be elevated greater than 250 seconds
•6. Significant anemia (hemoglobin less than 9 g/dL or hematocrit less than 27%)
•7. Significant blood loss requiring transfusion of blood products within 30 days prior to primary procedure
•8. Documented left ventricular ejection fraction less than 20%
•9. Renal insufficiency (glomerular filtration rate less than 30 ml/min or baseline serum creatinine greater than 2.5 mg/dL) or on renal replacement therapy
+39 more criteria

Locations (3)

Macquarie University

Sydney, New South Wales, Australia

Alfred Health

Melbourne, Victoria, Australia

Monash Health, Victoria Heart Hospital

Melbourne, Victoria, Australia

Key Dates

Start Date

October 21, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

December 17, 2025

Enrollment

ESTIMATED participants

Conditions

Vascular ClosureFemoral Arteriotomy Closure

Interventions

Ladera LBC System

DEVICE

The Ladera Suture-Mediated Large Bore Closure Study

NCT06851481

Vascular ClosureFemoral Arteriotomy Closure

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COMPLETEDNA

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

NCT03756558

Vascular Closure

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COMPLETEDNA

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

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 17, 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.

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The Ladera Large Bore Closure Feasibility Study

Inclusion Criteria

Exclusion Criteria

The Ladera Suture-Mediated Large Bore Closure 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

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

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