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The Ladera Large Bore Closure Feasibility Study

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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

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

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Eligibility

Age eligible for study : 21 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-01

Primary completion: 2025-02-01

Study completion finish: 2025-04-01

Study type

TREATMENT

Phase

Trial ID

NCT06358157

Intervention or treatment

DEVICE: Ladera LBC System

Conditions

• Vascular Closure
• Femoral Arteriotomy Closure

Condition: Vascular Closure, Femoral Arteriotomy Closure
DEVICE: Ladera LBC System
Melbourne, Victoria, Australia and more
Sponsor: Ladera Medical

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Alfred Health

Research sites nearby

Select from list below to view details:

Alfred Health
Melbourne, Victoria, Australia
Macquarie University
Sydney, New South Wales, Australia
Monash Health, Victoria Heart Hospital
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ladera LBC System 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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Secondary Safety Endpoint: Minor Arterial Access Site Closure-related Complications	Assessment of the incidence of minor complications 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
Secondary Performance Endpoint: Time-to-Ambulation	Time (hrs) from access site closure and primary procedural guidewire removal to when the participant stands and walks at least 20 ft/6 m without evidence of re-bleeding from the access site	Post-procedure, usually within 12 hours
Secondary Performance Endpoint: Time-to-Discharge Eligibility	Elapsed time (hours) from access site closure and primary procedural guidewire removal to when the participant is eligible for discharged from the hospital based on the assessment of the attending physician	Post-procedure, usually within 48 hours
Secondary Performance Endpoint: Incidence of Procedural Success	Incidence of hemostasis with use of the Ladera LBC System without major access site closure related complications	Through 30 days post-procedure
Secondary Performance Endpoint: Incidence of Device Technical Success	Incidence of successful deployment of the Ladera LBC System and achievement of hemostasis	Post-Procedure, usually within 3 hours

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Connect to trial

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References

Clinical Trials Gov: The Ladera Large Bore Closure Feasibility Study