Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With Common Femoral Artery Disease: A Retrospective Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adequate hemostasis - (efficacy)
研究概览
简要总结
To study the patient characteristics and outcomes associated with the real-world use of manual compression vs. vascular closure devices (VCDs) after common femoral artery (CFA) percutaneous access for coronary and endovascular interventions. An institutional procedural database, based on electronic medical record information will be abstracted to collect this information.
详细描述
The overall objective of the study will be to examine the safety and efficacy of the VASCADE closure device compared to manual compression (standard of care) to achieve hemostasis after endovascular procedures requiring access within a severely diseased CFA.
This study will be a retrospective single center review of 200 patients undergoing endovascular procedures utilizing vascular access within a severely diseased CFA between 2018 and 2020 at Yale New Haven Hospital. A random selection of patients undergoing hemostasis with manual compression (n = 100) and VASCADE vascular closure system (n = 100) will be conducted. The two groups will then be statistically compared with respect to 48-hour and 30-day safety and efficacy outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5, 6 or 7 Fr access within the CFA
- •ACT < 300 seconds
- •Age 18 - 90 years old
- •Severe common femoral arterial disease Percent stenosis > 50, which will be core-lab adjudicated
排除标准
- •Ipsilateral CFA access within 30 days preceding or subsequent to the index case
- •Prior ipsilateral closure device use, other than VASCADE
- •High bleeding risk ACT > 300 or > 250 with IIb/IIIa inhibitor Plt < 50K INR > 1.7 on the day of procedure Inherent coagulopathy NOAC, warfarin, or lovenox administered within 24 hours of the procedure
- •Suspected intraluminal thrombus, dissection, pseudoaneurysm, hematoma, or AV Fistula
结局指标
主要结局
Adequate hemostasis - (efficacy)
时间窗: within an hour immediately after procedure
No evidence of bleeding after device use
No complications after procedure - (safety)
时间窗: late (30-day)
Late complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality
次要结局
未报告次要终点