DRKS00020545招募中未知
A Prospective Multicenter Trial to Evaluate the Safety and Effectiveness of the ELANA Heart Bypass System in Patients undergoing Coronary Artery Bypass Grafting - SAFE-CAB
AMT Medical0 个研究点目标入组 75 人开始时间: 2021年7月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Able and willing to provide voluntary written Informed Consent and sign the ICF to participate in the study prior to any study related procedure,
- •2. Is 18 years or older,
- •3. Assigned for CABG by the cardiologist and/or cardiothoracic surgeon with one or more vessel disease including the left anterior descending coronary artery (LAD),
- •4. Agrees to attend all follow-up assessments for up to 2 years and is willing to comply with specified follow-up evaluations at clinical investigational sites and/or obtain all protocol-specified diagnostic tests.
排除标准
- •Patients meeting any of the following criteria at Study Visit 1: Day of Screening / Enrolment will be excluded from entry into the study:
- •1. Patient is unlikely to cooperate or is legally incompetent, including patients who are institutionalized by court or official order,
- •2. Any condition which could interfere with the patient’s ability to comply with the study,
- •3. Ongoing participation in any other interventional clinical study,
- •4. Female patients who are pregnant or lactating,
- •5. Females who are of child-bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child-bearing potential taking acceptable contraceptive precautions can be included,
- •Note: A highly effective method of birth control and one which is acceptable for this study, is defined as one that can achieve a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
- •6. History of cardiothoracic surgery,
- •7. Active smokers,
- •8. Patients with LVEF <30,
- •9. Concomitant cardiothoracic procedures (i.e. rhythm, aortic, valve surgery, etc.)
- •10. Requires a planned therapeutic, interventional, or surgical procedure within 1 month (30 days) before or after the scheduled index procedure,
- •11. Chronic or acute renal failure requiring renal replacement therapy,
- •12. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to scheduled index procedure,
- •13. History of bleeding disorders or coagulopathies,
- •14. Contradicted for LITA harvesting (i.e. obstruction / aortoiliac occlusive disease / radiation therapy at the thoracic region),
- •15. Need for urgent and/or emergent surgery for any reason,
- •16. During the operation, patients can still be excluded from the study in accordance to the instructions of use for the ELANA Heart Bypass.
研究者
相似试验
招募中
不适用
A Prospective Multicenter Trial to Evaluate the Safety and Effectiveness of the ELANA Heart Bypass System in Patients undergoing Coronary Artery Bypass Grafts (SAFE-CAB)Coronary Artery DiseaseNL-OMON56444AMT Medical B.V.92
进行中（未招募）
1 期
A clinical study investigating the safety and tolerability of brexpiprazole in the Treatment of Subjects with Bipolar I DisorderEUCTR2017-002225-38-PLOtsuka Pharmaceutical Development & Commercialization, Inc.360
进行中（未招募）
1 期
A clinical study investigating the safety and tolerability of brexpiprazole in the Treatment of Subjects with Bipolar I DisorderTreatment of Manic Episodes Associated with Bipolar I DisorderMedDRA version: 20.0Level: LLTClassification code 10068455Term: Bipolar I disorder, hypomanicSystem Organ Class: 100000004873EUCTR2017-002225-38-BGOtsuka Pharmaceutical Development & Commercialization, Inc.381
进行中（未招募）
1 期
A clinical study investigating the safety and tolerability of brexpiprazole in the Treatment of Subjects with Bipolar I DisorderEUCTR2017-002225-38-HROtsuka Pharmaceutical Development & Commercialization, Inc.381
进行中（未招募）
1 期
Open-label Trial of Brexpiprazole in the Treatment of Borderline Personality DisorderMedDRA version: 21.1Level: PTClassification code 10006034Term: Borderline personality disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 21.1Level: LLTClassification code 10006033Term: Borderline personalitySystem Organ Class: 10037175 - Psychiatric disordersBorderline Personality DisorderEUCTR2019-002897-30-ESOtsuka Pharmaceutical Development & Commercialization, Inc201