NCT07541235Not yet recruitingNot Applicable
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)
Ladera Medical1 site in 1 country214 target enrollmentStarted: August 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Primary Safety Endpoint
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Connective tissue disease (e.g., Marfan's Syndrome)
- •Thrombolytics (e.g., Tissue Plasminogen Activator (t-PA), streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the index procedure
- •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
- •Participants who are morbidly obese (Body Mass Index (BMI) > 40 kg/m2) or cachectic (BMI < 20 kg/m2)
- •Planned major intervention or surgery, including planned interventional catheterization procedure in the target leg, within 30 days following the interventional procedure
- •Participant unable to ambulate at baseline (i.e., confined to wheelchair or bed)
- •Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint
- •Known allergy to any of the materials used in the investigation device (refer to IFU)
- •Participant is known or suspected to be pregnant or lactating or planning to become pregnant within 30 days following the index procedure
- •Evidence of active systemic or local groin infection
- •Participant has other medical, social or psychological problem that in the opinion of the Investigator precludes them from participating
- •Participant is mentally incompetent or a prisoner
- •Participant would refuse blood transfusion if it were to be needed
- •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
- •Left Ventricular Ejection Fraction (LVEF) < 20%
- •Unilateral or bilateral lower extremity amputation
- •Known existing nerve damage in the target leg
- •Participants who have already participated in this Investigational Device Exemption (IDE) study Intra-Procedure
- •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
- •Access site in the external iliac and/or above/through the inguinal ligament
- •Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
- •Ipsilateral femoral venous sheath during the catheterization procedure
- •Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with Imaging and/or DUS
- •Participant in which there is difficulty inserting the introducer sheath
- •Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
- •Evidence of a hematoma (> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
- •Marked tortuosity (at the Investigator's discretion) of the femoral or external iliac artery in the target leg based on angiography, and/or DUS
- •Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
- •Index procedural sheath < 10 Fr or > 24 Fr
- •Activated clotting time (ACT) greater than 250 seconds, unless protamine has been administered, immediately prior to index procedure sheath removal and planned vascular closure
- •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
Arms & Interventions
The Ladera LBC System will be used in all participants enrolled in the study
Experimental
Intervention: Ladera LBC System (Device)
Outcomes
Primary Outcomes
Primary Safety Endpoint
Time Frame: 30 days
Freedom from Clinical Events Committee (CEC) adjudicated major complications of the target limb access site within 30 days post-procedure
Primary Performance Endpoint: Time to Hemostasis
Time Frame: Post-procedure, usually within 3 hours
The mean Time to Hemostasis (TTH) in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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