Actively Recruiting
The Ladera Suture-Mediated Large Bore Closure Study
Led by Ladera Medical · Updated on 2025-12-15
55
Participants Needed
6
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Ladera Suture-Mediated Large Bore Closure Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years old or older
- Scheduled for elective or planned percutaneous interventional catheterization using common femoral artery access with 10 to 24 Fr introducer sheaths
- Able to undergo emergency vascular surgery if needed due to closure complications
- Willing and able to complete follow-up visits
- Has mental capacity to consent and signs informed consent form
You will not qualify if you...
- Prior intra-aortic balloon pump at access site within 30 days before baseline
- Severe iliac artery narrowing (greater than 50%) or severe peripheral arterial disease (Rutherford Class 5 or 6)
- Common femoral artery or iliac artery diameter less than 6 mm
- Calcium buildup at the access site visible on CT scan
- Significant artery tortuosity or scarring at access site preventing device use
- Prior artery closure device use within 90 days or manual compression within 30 days
- Prior atherectomy, vascular surgery, graft, or stent at access site
- Use of glycoprotein IIb/IIIa inhibitors within 24 hours before or 48 hours after procedure
- Significant anemia (hemoglobin less than 9 g/dL or hematocrit less than 30%)
- Known bleeding disorders such as thrombocytopenia, hemophilia, or Von Willebrand's disease
- Renal insufficiency, dialysis, or kidney transplant
- Severe allergy to contrast agents that cannot be managed
- Unable to tolerate aspirin or other blood thinners
- Planned anticoagulation therapy expected to raise clotting time above 250 seconds for over 24 hours
- Connective tissue diseases like Marfan's syndrome
- Recent thrombolytic therapy within 24 hours before procedure
- Recent stroke, heart attack, or acute coronary syndrome within 8 weeks to 48 hours prior
- Morbid obesity (BMI over 40) or cachexia (BMI under 20)
- Planned major surgery or intervention within 30 days after procedure
- Unable to walk at baseline
- Participation in other investigational studies not completed
- Allergy to device materials
- Pregnant, breastfeeding, or planning pregnancy within 30 days after procedure
- Active local or systemic infection at groin
- Medical, social, or psychological conditions preventing participation
- Mentally incompetent or prisoner status
- Refusal of blood transfusion if needed
- Uncontrolled severe heart failure requiring ICU treatment within 24 hours prior
- Left ventricular ejection fraction below 20%
- Amputation of one or both lower limbs
- Known nerve damage in target leg
- Previous participation in this study
- Participation in other investigational studies
- Tissue tract longer than 8 cm from skin to artery
- Access site above inguinal ligament or not in common femoral artery
- Ipsilateral femoral venous sheath during procedure
- Difficulty with arterial punctures or multiple attempts
- Existing hematoma, arteriovenous fistula, pseudoaneurysm, or thrombosis at access site
- Arterial injury seen on angiography
- Sheath size less than 10 Fr or greater than 24 Fr
- Activated clotting time over 250 seconds before sheath removal unless reversed
- Uncontrolled blood pressure without medication at sheath removal time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Jessie McPherson Private Hospital
Clayton, Clayton VIC, Australia, 3168
Actively Recruiting
2
Macquarie University
Sydney, New South Wales, Australia
Actively Recruiting
3
Monash Health, Victoria Heart Hospital
Melbourne, Victoria, Australia
Actively Recruiting
4
AZ Sint-Jan Brugge AV
Bruges, Belgium
Actively Recruiting
5
OLVG Amsterdam
Amsterdam, Netherlands
Actively Recruiting
6
Erasmus University Medical Center
Rotterdam, Netherlands
Actively Recruiting
Research Team
S
Sarah L Canio
CONTACT
K
Keri Y Ng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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