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Vascular ClosureFASTENNCT06851481

The Ladera Suture-Mediated Large Bore Closure Study

A study testing Ladera LBC System in people with Vascular Closure and Femoral Arteriotomy Closure, run by Ladera Medical at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 18 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
55 participants
Where
6 sitesin 3 countries
Study dates
18 Aug 2025to 15 May 2026
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Patient is ≥ 18 years old
  • 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)
  • Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
  • Patient is willing and able to complete follow-up requirements
  • 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

Who cannot join

  • Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met:
  • Screening / Baseline
  • Prior intra-aortic balloon pump at access site within 30 days of baseline evaluation
  • 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
  • Common femoral artery and iliac lumen diameter is < 6 mm as confirmed with prior standard of care CT Imaging
  • Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging
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  • Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior CT Imaging
  • 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
  • Patients receiving glycoprotein IIb/IIIa inhibitors within 24 hours prior to, during, or within 48 hours after the catheterization procedure
  • Patients with significant anemia (Hgb < 9 g/dL, Hct < 30%)
  • 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
  • Patient 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 index procedure
  • Patients 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
  • Patient 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)
  • Patient 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
  • Patient has other medical, social or psychological problem that in the opinion of the Investigator precludes them from participating
  • Patient is mentally incompetent or a prisoner
  • Patient 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
  • Patients who have already participated in this Investigational study
  • Patients who are currently participating in any other investigational studies Intra-Procedure
  • 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
  • Access site above the most inferior border of the IEA and/or above the inguinal ligament based upon bony landmarks
  • Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
  • Ipsilateral femoral venous sheath during the catheterization procedure
  • 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
  • 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
  • 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

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Australia3 sites

  • Jessie McPherson Private Hospital

    Clayton, Clayton VIC, 3168

  • Monash Health, Victoria Heart Hospital

    Melbourne, Victoria

  • Macquarie University

    Sydney, New South Wales

Other trials in Australia

Netherlands2 sites

  • OLVG Amsterdam

    Amsterdam

  • Erasmus University Medical Center

    Rotterdam

Other trials in Netherlands

Belgium1 site

  • AZ Sint-Jan Brugge AV

    Bruges

Other trials in Belgium

About this study

Official title: A Prospective, Multi-Center, Single-Arm Study to Evaluate the Safety and Performance of the Ladera Medical Suture-Mediated Closure System When Used to Achieve Hemostasis of Common Femoral Arteriotomies in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures (the FASTEN Study)

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 NCT06851481
Study groupRoleWhat they receive
The Ladera LBC System will be used in all participants enrolled in the studyExperimentalNot described
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

    Freedom from Clinical Events Committee (CEC) adjudicated major complications of the target limb access site within 30 days post-procedure

    Measured: 30 days post-procedure

  2. Primary Performance Endpoint: Time to Hemostasis

    The mean Time to Hemostasis (TTH) in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.

    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 posted28 Feb 2025
  2. Study start18 Aug 2025
  3. Primary completion30 Jan 2026
  4. Study completion15 May 2026

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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06851481
Sponsor's protocol ID
CLN02002
Acronym
FASTEN
Status last verified
Jul 2026
First submitted
24 Feb 2025
Last updated
16 Jul 2026
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 6 sites in 3 countries.

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 5 inclusion and 47 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: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia, Netherlands, Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 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 NCT06851481.

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 16 Jul 2026.

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