NCT03616132Unknown不适用
A Prospective, Non-randomized, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Study Device related Composite Endpoint (Target Lesion Failure)
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, non-randomized trial
- Study population: 15 patients
- Clinical follow up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years;
- All the subjects perform the angiography, Intra-vascular ultrasound (IVUS) and Optical coherence tomography (OCT) at 1 year and 3 years.
- The primary study endpoint is target lesion failure (TLF) at 1 month post procedure; and imaging findings as the secondary study endpoint. To evaluate the feasibility, safety and performance of IBS.
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 performed 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 have ischemic stroke half a year before implantation, patients have 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 109/L, or > 700 x 109/L, white blood cells < 3 x 109/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.
研究组 & 干预措施
IBS implantation
Experimental
Implantation of IBS in patients with coronary artery lesions.
干预措施: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (Device)
结局指标
主要结局
Study Device related Composite Endpoint (Target Lesion Failure)
时间窗: 1 month 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
- Immediate Success Rate(Immediate postoperative)
- Clinical Success(Hospitalized period postoperative within 7 days)
- Performance Evaluation of IBS(Immediate postoperative)
- Device related Composite Endpoint (DoCE)(6 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure)
- Patient related Clinical Composite Endpoint (PoCE)(30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure)
- Stent Thrombosis defined by ARC(Acute(0-24 hours), Subacute(24 hours-30 days), Late(30 days-1 year),Very late(after 1 year))
- Acute stent retraction(Immediate postoperative)
- In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)(Immediate postoperative, 1 year, 3 years)
- In-stent, in-segment, proximal and distal Diameter stenosis(DS)(1 year, 3 years)
- In-stent, in-segment, proximal and distal Late lumen loss (LLL)(1 year, 3 years)
- In-stent, in-segment, proximal and distal Angiographic defined restenosis (ABR)(1 year, 3 years)
- Vasomotion(1 year, 3 years)
- Analysis of Morphometric, lesion composition and scaffold strut data obtained with OCT(: Immediate postoperative, 1 year, 3 years)
- Analysis of Vascular and scaffold morphology obtained with IVUS(Immediate postoperative,1 year, 3 years)
研究者
研究点 (2)
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