A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Number of Participants With Any Site-Related Major Adverse Events
研究概览
简要总结
The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared to standard manual compression.
详细描述
The study is a single center 1:1 randomized controlled trial in subjects undergoing coronary angiography and PCI.
It is anticipated that the enrollment period for this study will be two years.
The post procedure follow up period is up to 37 days following the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subject is between 18 and 85 years of age.
- •Cardiac catheterization procedure is indicated with involving access through a 5 French (F) or 6 French (F) introducer in the femoral artery.
- •Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
- •Subject or legally authorized representative has signed informed consent.
排除标准
- •Subject is unable to routinely 20 feet without assistance (e.g. requires a walker or wheelchair to mobilize or has paralysis)
- •Subject has an active systemic or cutaneous infection or inflammation (e.g. (septicemia at the time of the procedure).
- •Subject undergoing emergent or urgent cardiac catheterization for acute myocardial infarction.
- •Extensive calcification of the femoral artery as see on fluoroscopy.
- •Subject has systemic hypertension unresponsive to treatment (>180mm Hg systolic and >110mm Hg diastolic).
- •Subject has received thrombolytic therapy within the 72 hours prior to catheterization.
- •Subject has known bleeding disorder,such as Factor 5 deficiency, Idiopathic thrombocytopenic purpura (ITP), thrombasthenia, Von Willebrand's disease.
- •Is on warfarin with an International Ratio (INR)>1.
- •Platelet count is < 100,
- •Anemia (Hemoglobin <10 g/dl or Hematocrit<30%).
- •Subject has compromised femoral artery access site.
- •Subject procedure requires an introducer sheath size of > 6 French (F).
- •Subject has had prior vascular surgery or vascular grafts at the femoral artery access site.
- •Subject presents with hemodynamic instability or is in need of emergent surgery.
- •Subject has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days.
- •Subject has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of < 1 year.
- •Subject is participating in an investigational drug or another device research study that interferes with the current research study endpoints.
- •Pregnant or lactating subjects.
研究组 & 干预措施
Standard Manual Compression
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
干预措施: Standard Manual Compression (Procedure)
AXERA 2 Access System
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
干预措施: Vascular Access Device (Device)
结局指标
主要结局
Number of Participants With Any Site-Related Major Adverse Events
时间窗: Up to 37 days post procedure
Observation of any major access site related complications (number of participants).
次要结局
- Time to Hemostasis(From procedural sheath removal until hemostasis is achieved.)
- Time to Discharge Eligibility(Up to 1 day post procedure)
- Time to Actual Discharge(Up to 1 day post procedure)
- AXERA 2 Access System Success(At the time of the femoral artey access procedure up to 1 hour post procedure)
- Time to Ambulation(Up to 1 day post procedure)
- Ability to Sit up at 45-degree Angle(15 minutes of successful hemostasis)
- Minor Access Site Related Complications(Up to 37 days post procedure)
- Patient Satisfaction(Up to 37 days post procedure)
- Pain Score(Up to 37 days post procedure)
研究者
Frank Saltiel
Borgess Heart Institute, Chairman
Borgess Research Institute