CLinical comparison bEtween a manual suture and a sutureless coupling device (cOrVCD) coNnecting the subclavian Artery with a 4-finger graft in a complete aortic arch replacement: a RanDOmized controlled study

Corlife OHG (Germany)0 个研究点目标入组 40 人开始时间: 2013年9月23日最近更新: 2018年9月10日

适应症

试验速览

暂无简介。

•1. Patients with aneurysms (aortic caliber =5.5 cm) or chronic dissections in the area of the aortic arch with indication of an open surgery with an aortic arch prosthesis regarding ACCF/AHA guideline.
•2. Patient suitable for operation
•3. The patient has opted for an open surgery after deliberating about different available procedures
•4. An inner diameter of the Arteria subclavia sinistra of 6.1 to 12.5 mm
•5. Serum creatinine = 1.8 mg/dl
•6. Estimated life expectancy > 5 years
•7. Patient aged 18 to 80 years
•8. Written consent form for study participation

•1. Patient cannot undergo an open surgery with circulatory arrest
•2. Acute aortic dissection
•3. Previous radiation treatment of the target region
•4. Local or systemic infections
•5. Pre-terminal renal insufficiency (serum creatinine > 1.8 mg/dl) or contrast agent intolerance
•6. Conditions in the target region which inhibit an application of prosthetic material
•7. Any other life-limiting disease (with an estimated life expectancy < 5 years)
•8. Patient age = 18 or = 80 years
•9. Pregnancy or lactation
•10. Any other disease or medical treatment which interferes with safety or efficacy after assessment of the investigator
•11. Patients who are in a dependency relationship or employment with the sponsor or investigator
•12. Patients who are unable to give written consent for study participation
•13. Concurrent participation in another clinical study
•14. Hypersensitivity or allergy against nickel or titanium
•15. Hypersensitivity against suture material
•16. Absence of a written consent form for study participation

发起方

Corlife OHG (Germany)