Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- Neointimal hyperplasia volume obstruction
研究概览
简要总结
This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation.
Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting Stent.
The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as the primary imaging modality.
详细描述
In patients with diabetes mellitus (DM), drug eluting stents (DES) have been shown to be associated with greater neointimal suppression than bare-metal stents. However, there is an ongoing debate on the optimal drug-eluting stent in diabetic patients.
This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation.
Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting Stent.
The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as the primary imaging modality.
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)
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
- •Clinical Inclusion Criteria:
- •Subject is eligible for PCI.
- •Subject has symptomatic coronary artery disease (stable/unstable angina or Non-ST elevation myocardial infarction).
- •Subject has known DM.
- •Angiographic Inclusion Criteria:
- •Presence of 1 or 2 de novo native coronary artery lesions (maximum 1 lesion per epicardial coronary artery), with a visual estimation stenosis ≥ 50%.
- •Target lesion length 12-25mm, reference diameter 2.5-3.5mm.
排除标准
- •ST-segment elevation myocardial infarction <48h
- •Presence of cardiogenic shock pre-procedure
- •Contra-indications to dual antiplatelet therapy for 12 months
- •Left Ventricular Ejection Fraction ≤30%
- •GFR<30 ml/min/m2
- •Target vessel has been treated previously
- •Platelet count <75000/mm3 or >700000/mm3
- •Immunosuppressive therapy
- •Has received or waiting list for any transplant
- •Life-threatening disease with a life expectancy of < 12 months
- •Pregnant or breast feeding patient
- •Inability to provide informed consent
- •Angiographic Exclusion Criteria:
- •TIMI flow ≤ 1 prior to guide wire crossing
- •There is an additional lesion within the target vessel planned to be treated within the next 12 months
- •Target vessel is a saphenous vein graft
- •Target vessel is the left main, ostial LAD and/or ostial LCX.
- •Prior PCI of the target lesion (restenosis)
- •Lesion cannot be covered by a single stent (unplanned bailout stenting is allowed)
- •Involved side branch ≥2.5mm by visual estimation
- •Rotablator, ELCA or brachytherapy
- •Severe calcification of target lesion
结局指标
主要结局
Neointimal hyperplasia volume obstruction
时间窗: 9 months
The primary endpoint is assessed by Optical Coherence Tomography. It is defined as neointimal hyperplasia volume (mm3) divided by the stent volume multiplied by 100.
次要结局
- Percentage of uncovered struts(9 months)
- Cardiac death(12 months)
- Probable or definite stent thrombosis(12 months)
- Target vessel failure(12 months)
- Percentage of malapposed struts(9 months)
- Maximum percentage of NIH cross-sectional obstruction(9 months)
研究者
Dr Rafael Romaguera
Dr. Rafael Romaguera
Spanish Society of Cardiology