NCT03234894Unknown不适用
Clinical Study of the WoundCare360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures
Wound Care 360, Inc.0 个研究点目标入组 90 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- The percent of patients with common femoral nerve damage or with bleeding from femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
研究概览
简要总结
This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
详细描述
The study design is a single arm with 90 patients. The primary endpoints measure the risk for common femoral nerve damage and common femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
The sample size is 90 patients. The project objective is to demonstrate the safety of the device.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages 19 to 90
- •Patient or his/her legally authorized representative, has given written informed consent for participation prior to the procedure
- •Procedure is an interventional procedure
- •Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements
- •Patient is a candidate for elective, non-emergent cardiac or peripheral vascular catheterization from the femoral artery approach
- •Patient is willing to have a pre/post procedure ultrasound.
排除标准
- •Patients are <19 years old
- •Patients are >90years old
- •Patient has received GP IIb/IIIa inhibitors
- •Patient or patient's representative is unable to provide written informed consent.
- •Patient is unable or unwilling to adhere to data collection and follow-up requirements
- •Procedure is emergency PCI
- •Patient is on dialysis
- •Patient has a known diagnosis of fibromyalgia
- •Patients with acute coronary syndrome (i.e., unstable angina or myocardial infarction) ≤ 48 hours before this catheterization procedure.
- •Patients with systolic blood pressure < 90 mm Hg at the end of the catheterization procedure
- •Patients who are immunocompromised
- •Patients with preexisting systemic infection or local infections at the access site
- •Patients who are known or suspected to be pregnant, or are lactating
- •Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site above the inguinal ligament
- •Patients who have undergone prior vascular closure device use in the ipsilateral common femoral artery ≤ 30days before this catheterization procedure
- •Patients who have undergone prior use of manual or mechanical compression for closure in the ipsilateral common femoral artery ≤30 days before the catheterization procedure
- •Patients requiring a repuncture at a site previously punctured within 48 hours of the catheterization procedure
- •Patients who have undergone an antegrade puncture
- •Patients with puncture sites believed to be in the profunda femoris artery, superficial femoral artery, or at the bifurcation of these arteries
- •Patients with puncture tract angle >55°
- •Patients who are suspected to have experienced a femoral artery back wall puncture or who underwent > 1femoral artery puncture during the catheterization procedure
- •Patient with significant anemia (hemoglobin < 10 g/dL, Hct < 30%)
- •Patients with a known bleeding disorder, including thrombocytopenia (platelet count < 100,000 cells/μL), thrombasthenia, hemophilia, or von Willebrand's disease
- •Patients with systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg at the end of this catheterization procedure, unless systolic and/or diastolic pressure was lowered by pharmacological agents prior to the end of the catheterization procedure
- •Patients with a baseline INR >1.5 (e.g., on warfarin therapy)
- •Patients whose ACT >300seconds at the end of the catheterization procedure
- •Patients who have undergone administration of low molecular weight heparin (LMWH) within 8hours of this catheterization procedure
- •Patients in whom continued heparin or other anticoagulant/antiplatelet therapy is planned for this patient (with the exception of glycoprotein IIb/IIIa inhibitor therapy) during the first few hours following the catheterization procedure
- •Patients having a complication or complications at the femoral artery access site during the catheterization procedure including bleeding, hematoma, intraluminal thrombus, pseudoaneurysm, or arteriovenous fistula
- •Patients with an ipsilateral or bilateral lower extremity amputation(s)
- •Patient known to require extended hospitalization (e.g., patient is undergoing cardiac surgery)
- •Patients who have a planned endovascular procedure within the next 30days after the catheterization procedure
- •Patients who are currently participating in another investigational study that has not concluded the follow-up period
- •Patients who have already participated in the IDE study
- •Patients who cannot adhere to or complete the study for any reason including but not limited to geographical residence or life-threatening disease
结局指标
主要结局
The percent of patients with common femoral nerve damage or with bleeding from femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
时间窗: 24 hours
Femoral damage is indicated if the patient has an audible response during suture placement. Arterial laceration is visible bleeding during suture placement.
次要结局
- Patient-rated patient discomfort.(24 hour interview)
- The percent of patients who had a major complication.(30day interview)
- The percent of patients who had a minor complication.(30day interview)
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