The Ladera Large Bore Closure Feasibility Study (NCT06358157) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Ladera Large Bore Closure Feasibility Study
Australia30 participantsStarted 2024-10-21
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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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
What they're measuring
1
Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications