Femoral Artery closure using the Cardiva VASCADE Vascular Closure System (VCS) to reduce time to hemostasis and reduce time to ambulation and hospital discharge versus manual compression in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing 6 Fr or 7 Fr procedural sheaths

Cardiva Medical, Inc.0 个研究点目标入组 420 人开始时间: 2011年12月6日最近更新: 2020年1月13日

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•Clinically indicated for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 6 Fr or 7 Fr introducer sheath

•Key Pre-Operative Exclusion Criteria
•1. Active systemic or a cutaneous infection
•2. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids
•3. Ipsilateral femoral arteriotomy within the previous 30 days
•4. Planned endovascular procedure within the next 30 days
•5. Unilateral or bilateral lower extremity amputation(s)
•6. Extreme morbid obesity [Body Max Index (BMI) greater than 45 kg/m2] or underweight (BMI less than 22 kg/m2)
•7. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, backwall stick”, etc.)
•8. Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site

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