The Ladera Suture-Mediated Large Bore Closure Pivotal Study

NCT07541235 | Not Yet Recruiting

• 1 other identifier: CLN02003
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

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

  30 days

• 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:

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

• Prior intra-aortic balloon pump at access site within 30 days of baseline evaluation
• Participants 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, and/or DUS
• Common femoral artery and iliac lumen diameter is \< 6 mm as confirmed with prior standard of care CT Imaging, angiography, and/or DUS
• Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging and/or DUS
• Marked tortuosity (at the Investigator's discretion) of the femoral or external iliac artery in the target leg based on prior CT Imaging, angiography, and/or DUS
• 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
• Participants receiving glycoprotein IIb/IIIa inhibitors within 24 hours prior to, during, or within 48 hours after the catheterization procedure
• Participants with significant anemia (Hgb \< 9 g/dL, Hct \< 30%)
• Participant with known bleeding disorder including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease or known Type II heparin-induced thrombocytopenia
• Participant 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
• Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment
• Planned anticoagulation therapy post-procedure such that ACT is expected to be elevated above 250 seconds for more than 24 hours after the procedure

Sponsors & Collaborators

• Ladera Medical: lead

Study Sites (1)

Monash Health

Melbourne, Australia

Location

Central Study Contacts

Sarah Canio

CONTACT

14083165575; sarah.canio@laderamedical.com

Keri Ng

CONTACT

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: April 14, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

AU (1)