Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent (Development Code TCD-10023) With Biodegradable Polymer at 1, 2 and 3 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- OFDI assessed percent stent strut coverage
研究概览
简要总结
Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.
详细描述
We will enroll patients with multiple coronary lesions, which, as is routine practice, will be treated with the new DES in 2 sessions (second one approximately 3-5 weeks after the first one). We will assess lesions by OFDI after the implantation and at the time of 3 months follow-up, when we will ask patients to undergo a coronary angiography. Patients will then have a follow-up contact at 1 year after initial implantation.
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
- •Patient is at least 18 years old
- •Patients is a suitable candidate for Percutaneous Coronary Intervention (PCI)
- •Patient has multi-vessel disease with ≥2 de-novo lesions in native coronary arteries suitable for treatment with TCD-10023 DES
- •Target lesions are suitable for OFDI examination;
- •Patient requires staged procedure between 3-5 weeks after baseline procedure, according to investigator's judgement
- •Target vessel reference diameter is between 2.5 - 4.0 mm (visual assessment)
- •Patient has provided written informed consent
- •Patient is affiliated to social security or equivalent system (France only)
排除标准
- •- Patient has known allergy to sirolimus, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated)
- •Patient is not a suitable candidate for use of Dual Anti-Platelet Therapy (DAPT) because of active or recent bleedings or for use of vitamin K antagonist, like warfarin, dabigatran, rivaroxaban or acenocoumarol;
- •Patient is presenting with ST-segment elevated MI (STEMI) at baseline procedure
- •Patient has Killip-class > 1 at admission
- •Patient is in cardiogenic shock
- •Patient is a female of childbearing potential
- •Patient has life expectancy of less then 1 year
- •Patient is expected to undergo major surgery within 3 months
- •Patient has Left Main disease ≥ 50%
- •Target lesion at bifurcation requiring 2 stents technique
- •Target lesions are severely calcified
- •Target lesion is located within 3 mm of aorta-ostium
- •Patient has renal failure defined as estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m²
- •Target lesions require preparation other than balloon pre-dilatation
- •Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials
- •In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- •Patient is under judicial protection (France only)
研究组 & 干预措施
TCD-10023 drug eluting stent
All patients will be treated with the new Drug eluting stent TCD-10023
干预措施: TCD-10023 drug eluting stent (Device)
结局指标
主要结局
OFDI assessed percent stent strut coverage
时间窗: 3 months post procedure.
次要结局
- Target Lesion revascularization (TLR)(at 1, 3, 12 months)
- % of acquired mal-apposed stent struts(at 1, 2, 3 months)
- amount (mm³) of in-stent intimal hyperplasia(at 1, 2, 3 months)
- % stent strut coverage(at 1 and 2 months)
- % of stented lesions with >20% uncovered stent struts(at 1, 2, 3 months)
- Major Cardiac Adverse Events (MACE) defined as cardiac death, Q wave and non-Q wave Myocardial Infarction (MI) , emergent coronary artery bypass surgery, or target vessel revascularization (TVR)(at 1, 3, 12 months)
- amount (mm³)of in-segment hyperplasia(at 1, 2, 3 months)
- neo-intimal thickness (µm)(at 1, 2, 3 months)
- in-stent late lumen loss (mm) assessed by Quantitative Coronary Angiography (QCA)(at 3 months)
- % stented lesions with >10% uncovered struts(at 1, 2, 3 months)
- Target Lesion Failure (TLF - composite of cardiac death, Myocardial infarction, TLR(at 1, 3, 12 months)
- Stent thrombosis(at 1, 3 and 12 months)
- In-segment late lumen loss (mm) assessed by QCA(at 3 months)
- Target Vessel Revascularization (TVR)(at 1, 3, 12 months)