The Ladera Suture-Mediated Large Bore Closure Study

NCT ID: NCT06851481

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Vascular Closure; Femoral Arteriotomy Closure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Ladera LBC System

Intervention Type: DEVICE

Use of the Ladera LBC System to close the femoral arteriotomy

Interventions

Ladera LBC System

Use of the Ladera LBC System to close the femoral arteriotomy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is ≥ 18 years old

2. 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)

3. Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery

4. Patient is willing and able to complete follow-up requirements

5. 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

Exclusion Criteria

Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met:

Screening / Baseline

1. Prior intra-aortic balloon pump at access site within 30 days of baseline evaluation

2. 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

3. Common femoral artery and iliac lumen diameter is < 6 mm as confirmed with prior standard of care CT Imaging

4. Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging

5. Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior CT Imaging

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. Patients receiving glycoprotein IIb/IIIa inhibitors within 24 hours prior to, during, or within 48 hours after the catheterization procedure

10. Patients with significant anemia (Hgb < 9 g/dL, Hct < 30%)

11. 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

12. Patient 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 index procedure

19. Patients 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. Patient 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. Patient 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. Patient has other medical, social or psychological problem that in the opinion of the Investigator precludes them from participating

27. Patient is mentally incompetent or a prisoner

28. Patient 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. Patients who have already participated in this Investigational study

34. Patients who are currently participating in any other investigational studies Intra-Procedure

35. Patient 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

36. Access site above the most inferior border of the IEA and/or above the inguinal ligament based upon bony landmarks

37. Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels

38. Ipsilateral femoral venous sheath during the catheterization procedure

39. Patient in which there is difficulty inserting the introducer sheath or need for greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure

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. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device

43. Index procedural sheath < 10 Fr or > 24 Fr

44. Activated clotting time (ACT) greater than 250 seconds, unless protamine has been administered, immediately prior to index procedure sheath removal and planned vascular closure

45. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ladera Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jessie McPherson Private Hospital

Clayton, Clayton VIC, Australia

Site Status: RECRUITING

Macquarie University

Sydney, New South Wales, Australia

Site Status: RECRUITING

Monash Health, Victoria Heart Hospital

Melbourne, Victoria, Australia

Site Status: RECRUITING

AZ Sint-Jan Brugge AV

Bruges, , Belgium

Site Status: RECRUITING

OLVG Amsterdam

Amsterdam, , Netherlands

Site Status: RECRUITING

Erasmus University Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Australia; Belgium; Netherlands

Central Contacts

Sarah L Canio

Role: CONTACT

sarah.canio@laderamedical.com

408-316-5575

Keri Y Ng

Role: CONTACT

keri@inventure.group

Other Identifiers

CLN02002

Identifier Type: -

Identifier Source: org_study_id