Vascular Closure DeviceFASTEN IINCT07541235
The Ladera Suture-Mediated Large Bore Closure Pivotal Study
A study testing Ladera LBC System in people with Vascular Closure Device, run by Ladera Medical at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Closure Device
- 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
- 214 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2026to Oct 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 46Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Keri Ng contact
About this study
Official title: 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)
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.
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 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.
- Conditions
- Vascular Closure Device
- 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 group | Role | What they receive |
|---|---|---|
| The Ladera LBC System will be used in all participants enrolled in the study | Experimental | Not described Receives: Device: Ladera LBC System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Freedom from Clinical Events Committee (CEC) adjudicated major complications of the target limb access site within 30 days post-procedure
Measured: 30 days
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.
- First posted21 Apr 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Closure DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ladera Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541235
- Sponsor's protocol ID
- CLN02003
- Acronym
- FASTEN II
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07541235
- Acronym / sponsor ID
- FASTEN II / CLN02003
- Conditions
- Vascular Closure Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Ladera MedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized
| Arm | Type | Receives |
|---|---|---|
| The Ladera LBC System will be used in all participants enrolled in the study | Experimental | Device: Ladera LBC System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (46 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ladera LBC SystemUse of the Ladera LBC System to close the femoral arteriotomy | Device | The Ladera LBC System will be used in all participants enrolled in the study |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keri Ng contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ladera LBC System in people with Vascular Closure Device, run by Ladera Medical at 1 site 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 5 inclusion and 46 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: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Sarah Canio (14083165575, sarah.canio@laderamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 30 days). 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?
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 21 Apr 2026.