NCT06851481已完成不适用
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)
Ladera Medical14 个研究点 分布在 3 个国家目标入组 55 人开始时间: 2025年8月18日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 14
- 主要终点
- Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
The Ladera LBC System will be used in all participants enrolled in the study
Experimental
干预措施: Ladera LBC System (Device)
结局指标
主要结局
Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications
时间窗: 30 days post-procedure
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
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (14)
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