The Closer Trial: A Multi-center, Prospective, Single Arm Trial to Evaluate the Safety and Efficacy of the Rex Medical Closer Vascular Sealing System (VSS) for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 12
- 主要终点
- Time to Hemostasis
研究概览
简要总结
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
详细描述
The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-Op Inclusion Criteria:
- •1 - Acceptable candidates for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5, 6, or 7 Fr introducer sheath.
排除标准
- •Pre-Operative Exclusion Criteria:
- •Significant bleeding diatheses or coagulopathy
- •Planned endovascular or surgical procedures within next 30 days
- •Planned ipsilateral femoral arteriotomy within next 90 days
- •Arteriotomy in ipsilateral groin within the past 30 days with any residual hematoma, significant bruising or vascular complication
- •Previous vessel closure device used in ipsilateral groin within the past 90 days
- •Previous vascular surgery or repair in the vicinity of the target access site
- •Severe peripheral vascular disease in the ipsilateral limb requiring surgical or endovascular treatment within the pervious 30 days or next 30 days
- •Existing nerve damage in ipsilateral limb
- •Extreme morbid obesity (BMI > 4 kg/m2)
- •Intra-operative Exclusion Criteria:
- •Use of a procedural sheath that is < 5 Fr or > 7 Fr
- •Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure
- •Placement of an ipsilateral venous sheath for procedure
- •Procedural sheath placement either through the superficial femoral artery and into the profunda femoris artery, or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery
- •In subjects receiving unfractionated heparin, an ACT > 350 seconds, or > 250 seconds in the presence of a GP IIb/IIIa inhibitor
- •Procedures or existing medical conditions that may extend index hospitalization beyond 24 hours post-procedure
- •Systemic hypertension (SBP > 180 mmHg) or hypotension (SBP < 90 mmHg) just prior to enrollment
研究组 & 干预措施
Closer VSS
Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
干预措施: Closer VSS (Device)
结局指标
主要结局
Time to Hemostasis
时间窗: procedural, usually within 15 minutes of enrollment
Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis
Rate of Combined Major Access Site Closure-related Complications
时间窗: Through 30 days +/- 7 days
Primary safety endpoint - rate of combined major access site closure-related complications
次要结局
- Time to Ambulation(prior to hospital discharge, usually within 24 hours)
- Rate of Combined Minor Access Site Closure-related Complications(through 30 +/- 7 days)
- Time to Hospital Discharge(through hospital discharge, usually within 24 hours)
- Time to Discharge Eligibility(prior to hospital discharge, usually within 24 hours)
- Device Success(procedural, usually within 15 minutes of enrollment)
- Procedure Success(through 30 days +/- 7 days)