NL-OMON56505招募中不适用
Safety and Performance Study for Venous Large Hole Vascular Closure Device - ELITE study - PerQseal Elite Venous Clinical Study (ELITE-Venous)
Vivasure Medical Ltd.0 个研究点目标入组 19 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 19 years.
- •2. Clinically indicated for a percutaneous venous interventional catheter-based
- •procedure, e.g., mitral valve edge to edge repair, left atrial appendage device
- •closure, leadless pacemaker implantation, patent foramen ovale closure or use
- •of a circulatory assist device or extracorporeal oxygenation using a common
- •femoral venotomy created by a 14 to 24F sheath (venotomy up to 26F).
- •3. Subject is willing and able to provide appropriate study-specific informed
- •consent, follow protocol procedures, and comply with follow-up visit
- •requirements.
- •4. Females who are not pregnant or lactating and not planning to become
- •pregnant for the duration of the study.
排除标准
- •Baseline Exclusion Criteria: If any Baseline or Procedural Exclusion Criteria
- •listed below are met, then closure with PerQseal Elite device is not permitted,
- •1. Evidence of current systemic bacterial or cutaneous infection, including
- •groin infection,
- •2. Known bleeding diathesis, unstable INR, definite or potential coagulopathy,
- •platelet count < 100,000/µl or subjects on long term anticoagulants with an INR
- •> 2.2 within 12 hours prior to index procedure or uninterrupted NOAC
- •administration,
- •3. Significant anaemia (example: haemoglobin < 8 g/dL or haematocrit < 22%),
- •within 24 hours prior to index procedure,
- •4. Known type II heparin-induced thrombocytopenia,
- •5. Documented right ventricular dysfunction < 13%,
- •6. Ipsilateral or contralateral lower extremity amputation,
- •7. Previous groin surgery within the region of the ipsilateral vessel access,
- •8. Common femoral vein diameter stenosis > 50% or previous bypass surgery/stent
- •placement in the common femoral vein of target leg,
- •9. Known existing nerve damage in the target leg,
- •10. Nephrotic syndrome or renal insufficiency (baseline serum creatinine > 2.5
- •mg/dl) or albumin level < 3.5 g/dl or symptoms of pitting oedema,
- •11. Systolic pulmonary artery pressure > 60 mmHg
- •12. Known allergy to any of the materials used in the PerQseal Elite device
- •(refer to Investigator*s Brochure),
- •13. Subject is unsuitable for surgical repair of the target leg access site,
- •14. Subject has undergone a percutaneous procedure greater than 8F sheath in
- •the target vessel, within the 90-days prior to index procedure,
- •15. Subject has undergone a percutaneous procedure of 8F sheath or less using
- •an absorbable intravascular closure device for haemostasis, in the target
- •vessel, within the 90-days prior to index procedure,
- •16. Subject has undergone a percutaneous procedure of 8F sheath or less using a
- •suture mediated closure device or manual/mechanical pressure for haemostasis in
- •the target vessel, within the 30-days prior to index procedure,
- •17. History of DVT or pulmonary embolism or venous thrombotic event,
- •18. Splenectomy or suffering psoriasis or paraesthesia of the ipsilateral leg,
- •19. Further planned endovascular/catheter-based procedure in the target leg in
- •the 30- days following the index procedure,
- •20. Subject is enrolled in another investigational medical device or drug study,
- •21. Subject has been previously enrolled in this clinical study,
- •22. Subject is unable to maintain ipsilateral leg still during the index
- •procedure (restless leg syndrome),
- •23. Current COVID-19 infection (with or without symptoms), recent positive test
- •for COVID- 19 within two weeks, or recent exposure to a person with COVID-19
- •infection within two weeks.
- •Procedural Exclusion Criteria: *
- •24. Anatomically the common femoral vein is substantially posterior to the
- •femoral artery,
- •confirmed by Duplex ultrasound,
- •25. Initial common femoral venous access achieved other than with the use of an
- •ultrasound guided access approach,
- •26. If the venous access is, or suspected of being, via an artery,
- •27. Difficult dilation during initial target femoral vein access (e.g., that
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研究者
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