AMBULATE: Multi-center, RCT for Safety & Efficacy of Cardiva Mid-Bore Venous VCS v. Manual Compression to Close Femoral Venotomies After Catheter-based Interventions Via 6-12F ID Sheaths With Single or Multiple Access Sites Per Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 25
- 主要终点
- Time to Ambulation (TTA)
研究概览
简要总结
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
详细描述
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
Only patients with multiple access sites will be enrolled in order to support the desired indication. Randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.
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 (Outcomes Assessor)
盲法说明
Data Safety Monitoring Committee will adjudicate endpoint events, blinded to treatment assignment when possible
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acceptable candidate for an elective, non-emergent catheter-based procedure via the common femoral vein(s) using a 6 to 12 Fr inner diameter introducer sheath, with a minimum of 3 and maximum of 4 femoral venous access sites, and a maximum of 2 access sites/leg
- •Anticipated prolonged bedrest (5 hours or more) and / or overnight stay
排除标准
- •Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- •Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
- •Know history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3
- •Severe co-existing morbidities with life expectancy less than 12 months
- •Femoral arteriotomy or femoral venotomy in < 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
- •Planned femoral venous or arterial access within next 30 days
- •History of DVT, pulmonary embolism or thrombophlebitis
- •Significant anemia or renal insufficiency
- •BMI > 45 kg/m2 or < 20 kg/m2
- •Unable to routinely walk at least 20 ft. without assistance
- •LMWH within 8 hours before or after procedure
- •Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath; < 6 Fr or > 12 Fr inner diameter sheath use; obvious bleeding complications or tissue tract estimated to be < 2.5 cm deep
结局指标
主要结局
Time to Ambulation (TTA)
时间窗: Post-procedure, usually within 6 hours
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.
Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event
时间窗: 30 +/- 7 days post-procedure
Rate of combined major venous access site closure-related complications. The method used to determine what would be considered "major" venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.
次要结局
- Time to Discharge (TTD)(Prior to hospital discharge, usually within 24 hours)
- Number of Participants With Procedure Success(30 +/- 7 days post-procedure)
- Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event(30 +/- 7 days post-procedure)
- Total Post-Procedure Time (TPPT)(Post-procedure, usually within 6 hours)
- Time to Discharge Eligibility (TTDE)(Prior to hospital discharge, usually within 24 hours)
- Time to Hemostasis (TTH)(Post-procedure, usually within 3 hours)
- Time to Closure Eligibility (TTCE)(Post-procedure, usually within 6 hours)
- Number of Access Sites With Device Success(Procedural, usually within 15 minutes of enrollment)