NCT04545112Enrolling By Invitation不适用
Prospective, Non-randomized, First in Human (FIH) Clinical Study to Assess the Feasibility of the Novel Xeltis Coronary Artery Bypass Graft (XABG)
Xeltis7 个研究点 分布在 3 个国家目标入组 20 人开始时间: 2020年10月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Freedom from device related Serious Adverse Events (SAEs)
研究概览
简要总结
A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary safety and performance of the XABG technology in patients with multi-vessel atherosclerotic coronary artery disease, scheduled by the local Heart Team to undergo elective coronary artery bypass (CABG) surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All gender, 18 years of age or older with a minimum life expectancy of 2 years.
- •Elective multi-vessel atherosclerotic CAD patients, selected and accepted by the local Heart Team and confirmed by the Screening Committee for CABG surgery.
- •LIMA bypass graft to LAD coronary artery indicated and feasible.
- •XABG target vessel(s) with proximal occlusion and/or critical stenosis. and with a diameter of ≥ 2 mm and sufficient distal run-off (thrombolysis in myocardial infarction risk (TIMI)-Score ≥ 2).
- •Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
- •Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up CT scan and coronary angiogram.
- •Patient is suitable for percutaneous coronary intervention (PCI) procedures in case of required emergent procedures at discretion of the local Heart Team.
排除标准
- •Total arterial bypass grafting indicated and feasible
- •Any previous open-heart surgery or surgical/transcatheter procedure that could compromise imaging follow up.
- •History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation
- •Concomitant cardiac surgery (e.g. valve treatment, ablation).
- •Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days prior to the CABG procedure
- •Left ventricular ejection fraction ≤ 35%.
- •Severe kidney disease, renal dysfunction (Cr> 2.0mg/dL) or Glomerular Filtration Rate (GFR) < 50mL/min or active dialysis patients.
- •Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) <1.5 lit/sec.
- •Endocarditis, pericarditis or any other active systemic infection that would interfere with subject safety.
- •Active bleeding disorder and/or any coagulopathy or thromboembolic disease or other indication requiring anticoagulation
- •Known Heparin Induced Thrombocytopenia (HIT)
- •Abnormal blood values (e.g. leukopenia, anemia or thrombocytopenia) that could influence graft hemostasis or patient recovery.
- •Use of immunosuppressive therapy or medication or active clinically inflammatory/autoimmune disease or immunodeficiency that likely interferes with restorative therapies
- •Known and non-treatable allergies to study device (Nitinol) or agents/medication, such as contrast agents, antiplatelet therapy, beta-blocker, statins required for study assessment or optimal post-CABG medical treatment (hospital SOC).
- •Need for emergency surgery for any reason and/or intervention/surgery prior to and within 12 months after the CABG surgery that requires antiplatelet therapy discontinuation.
- •Currently in investigational device or drug study or participated in the last 30 days.
- •Pregnancy or females currently lactating or childbearing potential who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years.
- •Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
- •Has any other condition, in the opinion of the principal investigator, which would put the patient at increased risk from participating in the study or otherwise prevent participation.
- •Intra-operative Exclusion Criteria:
- •Severe calcified aorta (porcelain aorta) or diseased aorta that precludes proximal vein graft anastomoses
- •Unsuccessful LIMA to LAD anastomosis
- •After chest opening and visual inspection identification of active pericarditis/endocarditis and/or diffuse calcification in target vessels and/or any other reason precluding sufficient distal anastomoses.
- •Smaller distal coronary artery and/or poor distal run-off and/or XABG patient/device size mismatch as initially expected in the pre-operative workup.
- •Hemodynamic instability before XABG attempt
研究组 & 干预措施
XABG
Experimental
干预措施: CABG (Device)
结局指标
主要结局
Freedom from device related Serious Adverse Events (SAEs)
时间窗: 30 days
Procedural success during the first 30 days
时间窗: 30 days
XABG technology performs as intended with successful proximal and distal anastomoses and graft patency at the conclusion of the procedure and at 30 days. Patency is defined as a diameter stenosis less than 50%
次要结局
- Intimal hyperplasia area(12 months)
- Graft patency(30 days, 6 months, 12 months)
- Lumen diameter uniformity(30 days, 6 months, 12 months)
- Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)(30 days, 6 months, 12 months, and yearly until 5 years)
- Freedom from vein harvesting related wound infection, non-infective wound healing disturbances, and leg pain(30 days and 6 months)
研究者
研究点 (7)
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