The Ladera Suture-Mediated Large Bore Closure Study

NCT06851481 | Recruiting DMC FDA Device

• 1 other identifier: CLN02002
• Study Type: interventional
• Target: 55
• Locations: 3 countries
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications

  Freedom from Clinical Events Committee (CEC) adjudicated major complications of the target limb access site within 30 days post-procedure

  30 days post-procedure

• Primary Performance Endpoint: Time to Hemostasis

  The mean Time to Hemostasis (TTH) in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.

  Post-procedure, usually within 3 hours

Study Arms (1)

The Ladera LBC System will be used in all participants enrolled in the study

EXPERIMENTAL

Device: Ladera LBC System

Interventions

Ladera LBC System DEVICE

Use of the Ladera LBC System to close the femoral arteriotomy

The Ladera LBC System will be used in all participants enrolled in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years old
• 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)
• Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
• Patient is willing and able to complete follow-up requirements
• 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

You may not qualify if:

• Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met:
• Screening / Baseline
• Prior intra-aortic balloon pump at access site within 30 days of baseline evaluation
• 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
• Common femoral artery and iliac lumen diameter is \< 6 mm as confirmed with prior standard of care CT Imaging
• Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging
• Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior CT Imaging
• In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
• Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
• Prior atherectomy, vascular surgery, vascular graft, or stent in region of access site
• Patients receiving glycoprotein IIb/IIIa inhibitors within 24 hours prior to, during, or within 48 hours after the catheterization procedure
• Patients with significant anemia (Hgb \< 9 g/dL, Hct \< 30%)
• Patient with known bleeding disorder including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease or known Type II heparin-induced thrombocytopenia
• Patient with renal insufficiency (serum creatinine level \> 221 μmol/L or 2.5 mg/dL), on dialysis therapy, or with renal transplant
• Known severe allergy to contrast reagent that cannot be managed with premedication

Sponsors & Collaborators

• Ladera Medical: lead

Study Sites (6)

Jessie McPherson Private Hospital

Clayton, Clayton VIC, 3168, Australia

RECRUITING

Macquarie University

Sydney, New South Wales, Australia

RECRUITING

Monash Health, Victoria Heart Hospital

Melbourne, Victoria, Australia

RECRUITING

AZ Sint-Jan Brugge AV

Bruges, Belgium

RECRUITING

OLVG Amsterdam

Amsterdam, Netherlands

RECRUITING

Erasmus University Medical Center

Rotterdam, Netherlands

RECRUITING

Central Study Contacts

Sarah L Canio

CONTACT

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

Keri Y Ng

CONTACT

keri@inventure.group

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: August 18, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); NL (2); AU (3)