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Vascular ClosureNCT06358157

The Ladera Large Bore Closure Feasibility Study

A study testing Ladera LBC System in people with Vascular Closure and Femoral Arteriotomy Closure, run by Ladera Medical at 3 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Vascular Closure, Femoral Arteriotomy Closure
What is being tested?
Ladera LBC System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesAustralia
Study dates
21 Oct 2024to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 49Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • Alfred Health

    Melbourne, Victoria, 3004

  • Monash Health, Victoria Heart Hospital

    Melbourne, Victoria, 3168

  • Macquarie University

    Sydney, New South Wales

Other trials in Australia

About this study

Official title: Evaluation of the Safety and Performance of the Ladera Medical Suture-Mediated Large Bore Closure (LBC) System

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.

Read the 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.

Being tested
Ladera LBC System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ladera LBC SystemDevice

    Use of the Ladera LBC System to close the femoral arteriotomy

Study groups in NCT06358157
Study groupRoleWhat they receive
Ladera LBC SystemExperimentalThe Ladera LBC System will be used in all participants enrolled in the study
Receives: Device: Ladera LBC System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through 30 days post-procedure

  2. 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

    Measured: Post-procedure, usually within 3 hours

Secondary outcomes (5)

  1. 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.

    Measured: Through 30 days post-procedure

  2. 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

    Measured: Post-procedure, usually within 12 hours

  3. 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

    Measured: Post-procedure, usually within 48 hours

  4. Secondary Performance Endpoint: Incidence of Procedural Success

    Incidence of hemostasis with use of the Ladera LBC System without major access site closure related complications

    Measured: Through 30 days post-procedure

  5. Secondary Performance Endpoint: Incidence of Device Technical Success

    Incidence of successful deployment of the Ladera LBC System and achievement of hemostasis

    Measured: Post-Procedure, usually within 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start21 Oct 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, non-randomized
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06358157
Sponsor's protocol ID
CLN02001
Status last verified
Dec 2025
First submitted
29 Mar 2024
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ladera LBC System in people with Vascular Closure and Femoral Arteriotomy Closure, run by Ladera Medical at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications (time frame: Through 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06358157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.

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