NCT01100476已完成4 期
Single-center, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control (Diagnostic Arm of the Mynx 6/7F Study)
Cardiovascular Associates of the Delaware Valley2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Safety & Tolerability
研究概览
简要总结
The Mynx Vascular Closure Device (Mynx M5) is a sponge-like material used to close the hole in the artery after patients undergo a diagnostic endovascular procedures
详细描述
Key Inclusion:
- Patients >18 yrs of age
- Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath via the common femoral artery.
- Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by investigator.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is > 18 years of age
- •Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery
- •Patient has been informed and understands the nature of the study and provides written INformed COnsent approved by the appropriate Institutional Review Board (IRB) prior to enrollment
- •Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by the investigator
排除标准
- •Pre-Procedure Exclusion Criteria
- •Patient had a prior surgical procedure, PTA, stent placement, or vascular graft in the common femoral artery
- •Patient has a bleeding disorder such as thrombocytopenia
- •Patient has uncontrolled hypertension
- •Patient is morbidly obese (BMI >40 kg/m2
- •Patient is pregnant or lactating
- •Patient has a documented INR >1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitor
- •Patient has a known severe allergy to contrast medium
- •Patient has a known allergy to PEG
- •Patient is unable to ambulate at one hour secondary to a co-morbid condition
- •Patient is know to require an extended hospitalization or re-hospitalization (e.g.patient is undergoing coronary artery bypass graft (CABG) surgery) or patient is scheduled to have a CABG surgery <30 days following the procedure
- •Intra-Procedure Exclusion Criteria
- •Common femoral artery is <5mm in diameter
- •Patient with clinically significant peripheral vascular disease in the vicinity of the puncture
- •Puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
- •Patient has a posterior puncture or multiple punctures in an attempt to gain access
- •Patient has an ipsilateral venous sheath
- •Patient has a pre-existing arterial bleed/extravasation identified on pre-procedure femoral arteriogram, hematoma, pseudoaneurysm or arteriovenous fistula present prior to sheath removal
- •Patient has intra-procedural bleeding around the access site prior to sheath removal
结局指标
主要结局
Safety & Tolerability
时间窗: Enrollment approx for 4 months
To assess safety and tolerability of participants ambulating within one hour of placement of the Mynx M5 Closure Device. Participants will be assessed for adverse event occurrence for 30 +/-7 days.
次要结局
- Device success(30 +/- 7days)
研究者
Vijayendra K. Verma, MD
Principal Investigator
Cardiovascular Associates of the Delaware Valley
研究点 (2)
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