Clinical Evaluation of Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable Vascular Access Closure System and Perclose® ProGlide Suture-Mediated Closure System; Randomized, Comparative Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- TTH; Time to hemostasis
研究概览
简要总结
It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access Closure System through effectiveness and safety confirmation of hemostasis (TTH; Time to hemstasis) and ambulation (TTA; Time to ambulation) at the puncture site of common femoral artery (CFA) after the procedures of Fastseal® Biosorbable Vascular Access Closure System or Perclose® ProGlide Suture-Mediated Closure System during 1 month observation.
详细描述
Prospective, Single blind, randomized
Comparative study using the Fastseal® Bioabsorbable Vascular Access Closure System as an investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a comparator.
After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two devices. The subjects should follow designated physician's instructions accurately during the clinical trial period.There are about 6 times evaluations Including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 20 years old and 85 years old, randomized
- •Patient who submitted a written informed consent for the this trial
- •The subjects should be scheduled to have an angiography or intervention through the common femoral artery (CFA).
- •The subjects must be used a 6Fr sheath of the Terumo's RadiFocus Introducer II.
排除标准
- •In case of the subject has a functure site in both legs.
- •The patient who had the closing device insertion or manual compression at the targeted femoral artery within 30 days
- •Patients with severe bleeding disorders (Severe bleeding history, blood coagulation disorder, thrombocytopenia (under 100,000 of platelet count), hemophilia, anemia (Hgb<10g/dL, Hct<30%), Thrombasthenia, any related bleeding disorder
- •Hypertension patient BP ≥180/110mmHg
- •In case of thrombolysis(ex: streptokinase, urokinase, t-PA) within 24hr
- •If there is any hematoma, arteriovenous fistula(AVF), false aneurysm existed at the access site of femoral artery
- •Severe obesity BMI > 40kg/m2
- •In case of prior stent placement or artificial vessel insertion in the common femoral artery(CFA)
- •Under 5mm of Common femoral artery (CFA) diameter
研究组 & 干预措施
FASTSEAL® Bioabsorbable VCD
Fastseal® Bioabsorbable Vascular Access Closure System
干预措施: Vascular Closure Device (Device)
Perclose® ProGlide SMC System
Perclose® ProGlide Suture-Mediated Closure System
干预措施: Vascular Closure Device (Device)
结局指标
主要结局
TTH; Time to hemostasis
时间窗: From the procedure start - 1m 30s, 2m 30s, 3m 30s, 4m 30s, 6m 30s, 8m 30s, 10m 30s
Time interval between procedure and hemostasis
次要结局
- TTA(Time to ambulation) & Failure rate of hemostasis(From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr)