The Ladera Large Bore Closure Feasibility Study

NCT06358157 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLN02001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

  Assessment of the incidence of major adverse events of the target limb access site through 30 days post procedure attributed directly to the use of the Ladera LBC System without other likely cause analyzed on a per-participant basis.

  Through 30 days post-procedure

• Primary Performance Endpoint: Time to Hemostasis

  Elapsed time (min) from the removal of the Ladera LBC System and the primary procedural guidewire to first observed cessation of common femoral artery (CFA) bleeding, excluding cutaneous or subcutaneous oozing that is controlled with light/non-occlusive manual or mechanical pressure, and in the absence of a developing hematoma

  Post-procedure, usually within 3 hours

Secondary Outcomes (5)

• Secondary Safety Endpoint: Minor Arterial Access Site Closure-related Complications

  Through 30 days post-procedure

• Secondary Performance Endpoint: Time-to-Ambulation

  Post-procedure, usually within 12 hours

• Secondary Performance Endpoint: Time-to-Discharge Eligibility

  Post-procedure, usually within 48 hours

• Secondary Performance Endpoint: Incidence of Procedural Success

  Through 30 days post-procedure

• Secondary Performance Endpoint: Incidence of Device Technical Success

  Post-Procedure, usually within 3 hours

Study Arms (1)

Ladera LBC System

EXPERIMENTAL

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

Device: Ladera LBC System

Interventions

Ladera LBC System DEVICE

Use of the Ladera LBC System to close the femoral arteriotomy

Ladera LBC System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 or older
• 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
• Willing and able to give written informed consent and to complete a follow-up visit at 30 ± 7 days

You may not qualify if:

• Baseline
• Evidence of current systemic bacterial or cutaneous infection, including groin infection
• Known bleeding disorders including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease or known Type II heparin-induced thrombocytopenia
• Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants planned within 24 hours prior to primary procedure
• Glycoprotein IIb/IIIa inhibitors planned within 24 hours prior to the primary procedure, during the procedure, or within 48 hours after the primary procedure
• 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
• Significant anemia (hemoglobin less than 9 g/dL or hematocrit less than 27%)
• Significant blood loss requiring transfusion of blood products within 30 days prior to primary procedure
• Documented left ventricular ejection fraction less than 20%
• 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
• Significant inflow disease (iliac or artery diameter stenosis greater than 50%) and/or severe peripheral arterial disease (Rutherford Category 5 or 6), as confirmed with pre-primary procedure CT angiography
• Common femoral artery lumen diameter less than the indicated minimum based on pre-primary procedure CT angiography
• Evidence of marked tortuosity of the femoral or external iliac arteries in the target leg, based on pre-primary procedure CT angiography
• Evidence of arterial diameter stenosis (greater than 30%) within 15 mm proximal or distal to arteriotomy site based on pre-primary procedure CT angiography
• Evidence of anterior wall calcification of the target common femoral artery (other than small, diffuse deposits which in the opinion of the Investigator will not impede the vascular closure procedure) within 15 mm proximal or distal to arteriotomy site based on pre-primary procedure CT angiography

Sponsors & Collaborators

• Ladera Medical: lead
• Avania: collaborator

Study Sites (3)

Macquarie University

Sydney, New South Wales, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Monash Health, Victoria Heart Hospital

Melbourne, Victoria, 3168, Australia

Location

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: March 29, 2024
• First Posted: April 10, 2024
• Study Start: October 21, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)