The Ladera Large Bore Closure Feasibility Study

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.

Inclusion criteria

• 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

Exclusion criteria

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
• Prior target artery closure with any closure device within 90 days prior to the primary procedure, or closure with manual/mechanical compression within 30 days prior to the primary procedure
• Prior atherectomy, stent, vascular surgery, or vascular graph in the common femoral artery of target leg
• Known existing nerve damage in the target leg
• Unsuitable for surgical repair of the target leg access site
• Connective tissue disease (e.g., Marfan's Syndrome), or significant scarring of the target access site which in opinion of the Investigator, would preclude use of the investigational device in accordance with the IFU
• Recent (within 60 days) cerebrovascular accident or Q-wave myocardial infarction
• Morbidly obese or cachectic (BMI greater than 40 kg/m2 or less than 20 kg/m2)
• Planned major intervention or surgery, including planned endovascular/catheter-based procedure, in the target leg in the 30 days following the primary procedure
• Ipsilateral or contralateral lower extremity amputation
• Non-ambulatory (confined to bed or wheelchair)
• Known allergy to any of the materials used in the LBC System (refer to Instructions for Use)
• Pregnant, lactating, or planning to become pregnant within 30 days following the primary procedure
• Would refuse blood transfusion if it were to be needed
• Current enrollment in another investigational medical device or drug study
• Previous participation in this study
• Other medical, social, or psychiatric condition that in the opinion of the Investigator would interfere with participation in the study

Intra-Procedural

• Access site tissue tract (i.e., estimated distance from skin entry point to arterial anterior surface at arteriotomy) expected to be greater than the indicated maximum
• Initial common femoral arterial access for the primary procedure achieved with manual palpation or blind arterial stick access, without use of an image guided approach (ultrasound or angiography)
• During arterial puncture for the primary procedure, the target femoral artery suspected to have experienced a posterior arterial wall needle puncture or need for greater than 2 ipsilateral arterial punctures
• Primary procedural access site in the profunda femoris or superficial femoral artery or the bifurcation of these vessels
• Primary procedural access site located at the level or above the inferior epigastric artery and/or above the inguinal ligament based on bony/arterial landmarks (above femoral head on A-P projection)
• Difficult dilation during initial target femoral artery access (e.g., that damages or kinks dilators) while step-dilating up to the primary procedural sheath
• Primary procedural access site is in a vascular graft
• Primary procedural sheath ID greater than the indicated size, or primary procedural device greater than the indicated size if an expandable sheath is used
• Significant blood loss requiring transfusion of blood products during primary procedure
• Evidence of overt, actionable bleeding around the primary procedure sheath
• Primary procedure sheath in place longer than 6 hours
• Evidence of an acute hematoma (greater than 2 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the primary procedure access site
• Angiographic evidence of laceration, dissection or stenosis in the femoral artery that would preclude use of the investigational device
• Ipsilateral femoral venous sheath during the primary procedure
• Activated clotting time (ACT) greater than the target immediately prior to primary sheath removal and planned vascular closure or if ACT measurements are expected to be greater than the target seconds within 24 hours after primary procedure
• Uncontrolled hypertension (systolic blood pressure greater than the systolic maximum or diastolic blood pressure greater than the diastolic maximum) at the time of primary sheath removal and planned vascular closure
• Systolic blood pressure less than the systolic minimum at the time of primary procedural sheath removal and planned vascular closure