A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 16
- 主要终点
- Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
研究概览
简要总结
The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through the femoral artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 85 years of age.
- •Patient is clinically indicated for a diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
- •Patient is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
排除标准
- •Patient is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize or has known paralysis).
- •Patient has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
- •Patient has systemic hypertension unresponsive to treatment (>180mmHg systolic and >110mmHg diastolic).
- •Patient has received thrombolytic therapy within the 72 hours prior to catheterization.
- •Patient has a previously diagnosed significant bleeding coagulopathy, is on warfarin and has an INR ≥ 1.5 or has a platelet disorder, including known thrombocytopenia (platelet count <100,000), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (Hemoglobin< 10 g/dL, or Hct<30%).
- •Patient has a compromised femoral artery access site.
- •Patient procedure requires an introducer sheath size of> 6F.
- •Patient has had prior vascular surgery or vascular grafts at the femoral artery access site.
- •Patient presents with hemodynamic instability or is in need of emergent surgery.
- •Patient has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days of the current procedure.
- •Patient has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of< 30 dys or for other reasons has a life expectancy of less than 1 yaer.
- •Patient is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
- •Pregnant or lactating patients.
结局指标
主要结局
Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
时间窗: Procedure through 30 days follow-up.
Major Adverse Events Reported as Percentage of Participants With Adverse Events.
时间窗: Procedure through 30 day follow-up.
Observation of any major access site-related complication (percentage of participants).
Device Success
时间窗: Procedure
Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.
Minor Adverse Events
时间窗: Procedure through 30 day follow-up.
Observation of any minor access site-related complications.
Time to Hemostasis
时间窗: Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.
The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.
Time to Discharge Eligibility
时间窗: Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site.
Time to Actual Discharge
时间窗: Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.
The time from sheath removal to actual hospital discharge.
Time to Ambulation
时间窗: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding.
Percentage of Participants With Bed Elevation Within 15 Minutes.
时间窗: Post procedure
Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects.
次要结局
- Time to Hemostasis(Hemostasis was evaluated immediately following procedural sheath removal.)
- Time to Ambulation(Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.)