The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 4
- 主要终点
- Device/Procedure Failure
研究概览
简要总结
Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure following both diagnostic and interventional procedures as assessed by clinical and imaging criteria.
详细描述
The objective of this study is to evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure following both diagnostic and interventional procedures as assessed by clinical and imaging criteria for venous thrombosis at the site of closure device deployment.
This is a single-center prospective study of patients who are undergoing either diagnostic or interventional procedures. A total of 208 patients will be enrolled in this study and will be followed through hospital discharge for safety purposes.
The primary safety endpoint will include both deep venous thrombotic and bleeding/vascular injury related complications prior to discharge. Outcomes will be assessed via clinical evaluation and imaging with clinically indicated as follow:
Assessment of venous thrombosis i. Clinical: Physical exam findings consistent with venous thrombotic/thromboembolic related complication:
- Redness or swelling at the venous puncture site
- Increased lower extremity edema
- Calf pain
- New onset or worsening shortness of breath
- New onset of pleuritic chest pain ii. and if clinically indicated, imaging: venous Doppler ultrasound assessment of obstructive or non-obstructive deep vein thrombosis (DVT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Patients > 18 years of age scheduled for a percutaneous diagnostic or interventional procedure that have either a 5, 6, or 7F sheath placed in the common femoral vein.
排除标准
- •Patient has a history of a bleeding disorder
- •Previous history of venous thrombosis or thromboembolism
- •Patient is pregnant or lactating
- •Patient has a known severe allergy to contrast medium
- •Patient has a known allergy to PEG
- •7. Patient is known 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)
- •Multiple (>1) attempts at venous access were attempted in the target vein
- •Patient has intra-procedural bleeding around the access site prior to sheath removal
- •Critically ill patients requiring intravenous vasopressors for blood pressure stabilization
- •Ipsilateral femoral artery puncture or sheath insertion
- •Glycoprotein IIb/IIIIa use
- •Any bleeding or vascular access-site complication evident pre-venous closure
结局指标
主要结局
Device/Procedure Failure
时间窗: intraoperative
Device failure is defined as either the inability to deploy the device or device deployment with inadequate hemostasis requiring conversion to immediate manual pressure, or the eventual need for alternative methods to obtain hemostasis.
Assessment of Venous Thrombosis
时间窗: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours
i. Clinical: Physical exam findings consistent with venous thrombotic/thromboembolic related complication: * Redness or swelling at the venous puncture site * Increased lower extremity edema * Calf pain * New onset or worsening shortness of breath * New onset of pleuritic chest pain ii. and if clinically indicated, imaging: venous Doppler ultrasound assessment of obstructive or non-obstructive deep vein thrombosis (DVT)
Bleeding or Vascular Related Complications
时间窗: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours
i. Damage to the vessel requiring surgical repair ii. Access site bleeding requiring the need for transfusion iii. Nerve injury at access site iv. Generalized infection (septicemia with typical signs, symptoms and positive blood cultures shortly after the index procedure, and requiring treatment with intravenous (IV) antibiotics)Pseudo-aneurysms requiring invasive treatment
次要结局
未报告次要终点