The Ladera Suture-Mediated Large Bore Closure Pivotal Study (FASTEN II)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Closure Device
• Intervention / Treatment: Device: Ladera LBC System

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 efficacy 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.

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Canio; Phone Number: 14083165575; Email: sarah.canio@laderamedical.com
• Study Contact Backup: Name: Keri Ng

Study Locations

• Australia
  • Melbourne, Australia
    • Monash Health
    • Contact: Robert Gooley, A/Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant is ≥ 18 years old
2. 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)
3. Participant is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
4. Participant is willing and able to complete follow-up requirements
5. 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

Exclusion Criteria:

1. Prior intra-aortic balloon pump at access site within 30 days of baseline evaluation
2. 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
3. Common femoral artery and iliac lumen diameter is < 6 mm as confirmed with prior standard of care CT Imaging, angiography, and/or DUS
4. Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging and/or DUS
5. 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
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
9. Participants receiving glycoprotein IIb/IIIa inhibitors within 24 hours prior to, during, or within 48 hours after the catheterization procedure
10. Participants with significant anemia (Hgb < 9 g/dL, Hct < 30%)
11. 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
12. Participant with renal insufficiency (serum creatinine level > 221 μmol/L or 2.5 mg/dL), on dialysis therapy, or with renal transplant
13. Known severe allergy to contrast reagent that cannot be managed with premedication
14. Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment
15. Planned anticoagulation therapy post-procedure such that ACT is expected to be elevated above 250 seconds for more than 24 hours after the procedure
16. Connective tissue disease (e.g., Marfan's Syndrome)
17. Thrombolytics (e.g., Tissue Plasminogen Activator (t-PA), streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the index procedure
18. Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction or acute coronary syndrome (i.e., unstable angina or myocardial infarction) within 48 hours of the primary procedure
19. Participants who are morbidly obese (Body Mass Index (BMI) > 40 kg/m2) or cachectic (BMI < 20 kg/m2)
20. Planned major intervention or surgery, including planned interventional catheterization procedure in the target leg, within 30 days following the interventional procedure
21. Participant unable to ambulate at baseline (i.e., confined to wheelchair or bed)
22. Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint
23. Known allergy to any of the materials used in the investigation device (refer to IFU)
24. Participant is known or suspected to be pregnant or lactating or planning to become pregnant within 30 days following the index procedure
25. Evidence of active systemic or local groin infection
26. Participant has other medical, social or psychological problem that in the opinion of the Investigator precludes them from participating
27. Participant is mentally incompetent or a prisoner
28. Participant would refuse blood transfusion if it were to be needed
29. New York Heart Association (NYHA) Class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit within 24 hours prior to the index procedure
30. Left Ventricular Ejection Fraction (LVEF) < 20%
31. Unilateral or bilateral lower extremity amputation
32. Known existing nerve damage in the target leg
33. Participants who have already participated in this Investigational Device Exemption (IDE) study Intra-Procedure
34. Participant has a tissue tract (i.e., estimated distance from skin entry point to arterial anterior surface at arteriotomy) expected to be greater than 8 cm
35. Access site in the external iliac and/or above/through the inguinal ligament
36. Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
37. Ipsilateral femoral venous sheath during the catheterization procedure
38. Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with Imaging and/or DUS
39. Participant in which there is difficulty inserting the introducer sheath
40. Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
41. Evidence of a hematoma (> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
42. Marked tortuosity (at the Investigator's discretion) of the femoral or external iliac artery in the target leg based on angiography, and/or DUS
43. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
44. Index procedural sheath < 10 Fr or > 24 Fr
45. Activated clotting time (ACT) greater than 250 seconds, unless protamine has been administered, immediately prior to index procedure sheath removal and planned vascular closure
46. Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or hypotension (systolic blood pressure less than 90 mmHg) without pharmacological intervention at the time of index sheath removal and planned vascular closure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Ladera LBC System will be used in all participants enrolled in the study	Device: Ladera LBC System; Use of the Ladera LBC System to close the femoral arteriotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ladera Medical

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CLN02003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No