NL-OMON50786已完成不适用
Safety and Performance Study of Large Hole Vascular Closure Device - Frontier V study - Frontier V
Vivasure Medical Ltd0 个研究点目标入组 2 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •I. Over 18 years of age.
- •II. Subject is willing and able to provide appropriate study-specific informed
- •consent, follow protocol procedures, and comply with follow-up visit
- •compliance.
- •III. Clinically indicated for an endovascular procedure using a common femoral
- •arteriotomy created by a 14 - 22 F sheath.
排除标准
- •I. Severe acute non-cardiac systemic disease or terminal illness with a life
- •expectancy of less than four months.
- •II. Evidence of systemic bacterial or cutaneous infection, including groin
- •III. Known bleeding diathesis (including severe liver disease), definite or
- •potential coagulopathy, platelet count < 100,000/µl or patients on long term
- •anticoagulants with an INR greater than 2 at time of procedure or known type II
- •heparin-induced thrombocytopenia.
- •IV. Previous groin surgery within the region of the ipsilateral access.
- •V. Severe; claudication or peripheral vascular disease (e.g. Rutherford
- •category 3 or greater or ABI < 0.5), documented untreated iliac artery diameter
- •stenosis > 50% or previous bypass surgery/stent placement in the common femoral
- •artery of ipsilateral limb.
- •VI. Known allergy to any of the materials used in the PerQseal ® + or PerQseal®
- •Introducer (refer to Investigator*s Brochure for materials list).
- •VII. Subject has undergone a percutaneous procedure using a non-absorbable
- •vascular closure device (excluding suture mediated) for haemostasis in the
- •ipsilateral target leg.
- •VIII. Patients that have undergone a percutaneous procedure in the ipsilateral
- •leg, within the previous 30 days.
- •IX. Patients that have undergone a percutaneous procedure using an absorbable
- •intravascular closure device for haemostasis, in the ipsilateral leg, within
- •the previous 90 days.
- •X. Evidence of arterial diameter stenosis > 20% or anterior or circumferential
- •calcification within 20 mm proximal or distal to target arteriotomy site based
- •on pre-procedure CT angiography.
- •XI. Females who are pregnant or lactating or in fertile period not taking
- •adequate contraceptives. A pregnancy test may be performed.
- •XII. Patients that have a lower extremity amputation from the ipsilateral or
- •contralateral limb.
- •XIII. Target puncture site is located in a vascular graft.
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