A Randomized Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES for Percutaneous Coronary Intervention in Patients With Diabetes Mellitus: an Investigator-initiated Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 6
- 主要终点
- In-stent neointimal volume
研究概览
简要总结
The objective of the study is to compare angiographic and clinical performance of Abluminus DES+ versus Everolimus-eluting DES in patients with diabetes mellitus.
详细描述
The present clinical investigation is designed as a prospective, multicentre, national, randomized, open label, 2-arm parallel group, pilot trial comparing Abluminus DES+ versus Everolimus-eluting DES on Late Lumen Loss and clinical outcomes in diabetic patients undergoing Percutaneous Coronary Intervention.
A total of 165 patients will be recruited and randomized in the two groups in a 2:1 ratio at up to 6-8 Italian sites.
After index procedure, patients will be followed up by angiographic follow-up at 9 months and clinical follow-up at 12 months.
The study design is open label, since it is not possible to blind the investigators as to the stent type. However the members of the Event Adjudication Committee will be blinded to the patient. assignment. All medical records, source documentation and event information collected for the adjudication process will be blinded to treatment assignment.
In addition the primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The members of the Event Adjudication Committee will be blinded to the patient assignment. All medical records, source documentation and event information collected for the adjudication process will be blinded to treatment assignment
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
- •Diabetes mellitus
- •Documented CAD: stable or unstable angina, Non-ST segment MI, silent ischemia or positive functional study
- •PCI considered appropriate and feasible
- •Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length);
- •Patient provides written informed consent
- •Patient agrees to all required follow-up procedures and visits.
- •Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm.
排除标准
- •The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus, everolimus, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled);
- •Any contraindication to the implant of the Abluminus DES+
- •Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use effective methods of contraception;;
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
- •Previous coronary intervention on target vessel in the 3-months prior to enrollment;
- •Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- •Previously documented left ventricular ejection fraction (LVEF) <30%;
- •Evident cardiogenic shock before randomization;
- •Patients with left main stem stenosis (>50% by visual estimate);
- •In-stent restenosis;
- •ST-segment elevation MI;
- •Chronic total occlusion.
- •Culprit lesion to a Saphenous Vein graft
研究组 & 干预措施
ABLUMINUS DES+
device implantation during coronary angioplasty
干预措施: device implantation during coronary angioplasty (Device)
Everolimus-eluting DES
device implantation during coronary angioplasty
干预措施: device implantation during coronary angioplasty (Device)
结局指标
主要结局
In-stent neointimal volume
时间窗: 9-month follow-up
In-stent neointimal volume, measured with OCT, following PCI with Abluminus DES+ compared with in-stent neointimal volume following PCI with Everolimus-eluting DES.
次要结局
- Lesion success(24 hours)
- Procedural success(24 hours)
- Neointimal area(9-month follow-up)
- Stent thrombosis(12 months)
- Cardiac death(12 months)
- Device success at 24 hours(24 hours)
- Target lesion revascularization(12 months)
- Target Lesion Failure(12 months)
- Target vessel myocardial infarction(12 months)