Cardica C - Port xA * Anastomotic System - C - Port Connector

ST Europe bv.0 个研究点目标入组 78 人开始时间: 待定最近更新: 2024年6月24日

适应症

试验速览

暂无简介。

•- Undergoing CABG
•- Able to give informed consent able to understand the intent and clinical meaning of the study as well as its implication.
•- Patients 18 years old or older
•- Willing and able to have follow-up visits and examinations
•- Standard Euroscore < 2

•- Procedure is done as an emergency operation
•- Unable to meet study requirements, i.e. mobility challenge
•- Participation in any other clinical trial
•- Pregnancy
•- Not a standard CABG operation or is concomitant with heart valve surgery
•- History of any cardiac surgery other than PTCA and stent placement
•- History of IABP within the last 30 days
•- Congestive heart failure or been classified NYHA Class IV in the last 30 days
•- History of bleeding disorder or history of thromboembolic disease requiring anticoagulation therapy
•- Hemodynamically unstable
•- History of acute or chronic dialysis
•- Creatinine level of > 200 mmol/ml or 2,3 mg/dL in the last 30 days
•- Documented or suspected acute systemic infection
•- Need for immunosuppressive therapy
•- Cerebrovascular accident within the last 2 weeks
•- Allergy or other contraindication for aspirin or other anticoagulant/antiplatelet therapy

发起方

ST Europe bv.