NCT03509142已完成不适用
A Prospective, Single-Center, First-in-Man Trial of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in Patients With Coronary Artery Disease: IRONMAN-I
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Late Lumen Loss
研究概览
简要总结
The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System（IBS）. The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS. To provide the basis for subsequent large-scale, multi-center, randomized controlled clinical trials of IBS.
详细描述
A prospective, single-center, First-in-Man trial;
Study population: 45 subjects.
45 subjects will be randomly assigned into two cohorts: cohort 1(n=30), cohort 2(n=15)
The clinical follow up will be performed in all subjects at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years post procedure;
The Angiographic, Intra-Vascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) will be performed at 6 months and 2 years post procedure in cohort 1. The Angiographic, IVUS and OCT will be performed at 1 year and 3 years post procedure in cohort 2.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients participating in this clinical trial must meet the following criteria:
- •Age of 18-75, males or non pregnancy females;
- •Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI;
- •One target lesion, and target lesion can be completely covered by a single stent;
- •Target lesion length ≤ 18 mm, target lesion diameter between 3.0 mm to 3.5 mm (visual);
- •Visual assessment of target lesion stenosis ≥70%, TIMI blood flow≥ 1;
- •Subject who understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
排除标准
- •Patients will be excluded if any of the following conditions apply:
- •Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
- •Implantation of stent in target vessel within 1 year, patients with planned intervention again within six months;
- •Patients who had coronary artery bypass (coronary artery bypass grafting);
- •Patients with contraindications for coronary artery bypass graft surgery;
- •Severe heart failure (NYHA class III and above) or left ventricular ejection fraction<40% (ultrasonic or left ventricular angiography);
- •Preoperative renal function: serum creatinine > 2.0 mg/dl or 177 mu mol/L; receiving hemodialysis;
- •Patients had ischemic stroke half a year before implantation, patients had transient ischemic attack 3 months before implantation, patients have high coagulation tendency judged by investigator or laboratory examination;
- •Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy; patients would not allow to undergoing antithrombotic therapy;
- •Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer, rapamycin and metal allergies;
- •Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc;
- •The patient's life expectancy is less than 12 months;
- •Patient participated in other drug or medical device study and does not meet the primary study endpoint in clinical trials time frame;
- •Poor compliance and patients unable to complete the study in accordance with the requirements;
- •Patient with heart transplant;
- •The unstable arrhythmia, such as high risk ventricular extra systole and ventricular tachycardia;
- •Cancer needs chemotherapy;
- •Patients of immune suppression, autoimmune diseases, planned or undergoing immunosuppressive therapy;
- •Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
- •With six months for elective surgery requires stop using aspirin and clopidogrel;
- •Blood test prompted platelet count < 100 x 10^9/L, or > 700 x 10^9/L, white blood cells < 3 x 10^9/L, or abnormal liver function (ALT, AST 3 times greater than normal range);
- •Patients with diffuse peripheral vascular disease; cannot use 6F catheter;
- •Patients with valvular surgery in the past.
- •Exclusion criteria by angiography:
- •Chronic total occlusion (TIMI blood flow=0 before implantation) , left main coronary artery lesion, ostial lesion, multiple vessel lesion, branch lesion and bridge lesion which branch vessel diameter ≥ 2.0 mm (if the ostium of branch vessel stenosis >40% or needs balloon predilation); visible thrombus in target vessels;
- •Severe calcified lesions and distorted disease which unable to predilation, lesion not suitable for stent delivery and expansion;
- •In-stent restenosis;
- •Myocardial bridge is involved in target lesion;
- •In order to reach the target lesion, study stent has to go through the previous implanted stent;
- •Predilation balloon can't expand completely in target lesion site, judgment standard for fully expansion as below, patients are excluded when do not meet any item:
- •A.DS% < 40% (visual), highly recommend DS% ≤20% B.TIMI blood flow= class 3 (visual) C.No angiography complications (e.g., distal embolization, lateral branch closed) D.No interlining level NHLBI type D - F E.No continuous chest pain (> 5 minutes), and F.No lower or higher ST segment >5 minutes.
结局指标
主要结局
Late Lumen Loss
时间窗: 6 months after implantation
Late Lumen Loss
Study Device related Composite Endpoint (Target Lesion Failure)
时间窗: 6 months after implantation
Target Lesion Failure is defined as the composited endpoints of including cardiac death, Target vessel related myocardial infarction (TV-MI) and clinical indicated target lesion revascularization (CI-TLR), also known as MACE (major adverse cardiac events).
次要结局
- Analysis of percentage area obstruction by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Analysis of healing score by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Analysis of vessel area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Analysis of scaffold area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Analysis of percentage area obstruction by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Performance Evaluation of IBS(Immediate post procedure)
- Device related Composite Endpoint (DoCE)(1 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure)
- In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- In-stent, in-segment, proximal and distal percent of diameter stenosis (DS, %)(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Analysis of incomplete strut apposition by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Analysis of lumen area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Immediate Success Rate(Immediate post procedure)
- Stent Thrombosis defined by ARC(Acute (0-24 hours), Subacute (24 hours-30 days), Late (30 days-1 year), Very late (after 1 year))
- Analysis of proportion of strut coverage by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Analysis of neointimal area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Clinical Success(Hospitalized period post procedure within 7 days)
- Patient related Clinical Composite Endpoint (PoCE)(1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure)
- In-stent, in-segment, proximal and distal angiographic defined restenosis (ABR)(6 months, 1 year, 2 years, 3 years)
- Analysis of neointimal thickness by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Analysis of volumetric obstruction by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Analysis of late recoil area by IVUS(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
- Thickness of acute stent recoil (mm)(Immediate post procedure)
- In-stent, in-segment, proximal and distal late lumen loss (LLL)(1 year, 2 years, 3 years)
- Vasomotion(6 months,1 year, 2 years, 3 years)
- Analysis of late recoil by OCT(Immediate post procedure, 6 months, 1 year, 2 years, 3 years)
研究者
研究点 (2)
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