IN-PACT CORO INtimal hyPerplasia evAluated by oCT in de Novo COROnary Lesions Treated by Drug-eluting Balloon and Bare-metal Stent
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary Endpoint: Neo-intimal area (mm²).
研究概览
简要总结
Restenosis due to neointimal hyperplasia causes repeat target vessel revascularization in a relevant number of patients undergoing percutaneous coronary interventions (PCI). Drug-eluting stents (DES) are currently adopted to reduce the rate of restenosis; however, they may increase risk of stent thrombosis.
Experimental data and first clinical experiences showed that inhibition of neointimal hyperplasia may be obtained by local administration of anti-proliferative drugs (like paclitaxel) loaded on the surface of angioplasty balloons. Data on the efficacy of novel coronary drug-eluting balloons (DEBs) are lacking.
Aims of this open label prospective, randomized trial is to evaluate neointimal hyperplasia in patients undergoing bare-metal stent (BMS) implantation alone compared to those receiving additional DEB use and to assess if the technique of DEB use may affect the degree of neointimal hyperplasia.
Neointimal hyperplasia will be assessed by Optical coherence tomography (OCT).
详细描述
Background. Restenosis due to neointimal hyperplasia causes repeat target vessel revascularization in a relevant number of patients undergoing percutaneous coronary interventions (PCI). Drug-eluting stents (DES) are currently adopted to reduce the rate of restenosis and repeat revascularizations in the majority of cases. However, a known drawback that limits the clinical application of DES technology is the possible increased risk of stent thrombosis, requiring the need of a prolonged dual antiplatelet therapy. Such phenomenon is strongly related to the profound inhibition of stent strut endothelization, that leads to the presence of uncovered stent struts, and to the persistence of polymer molecules which may induce inflammatory reactions in the vessel wall.
Experimental data and first clinical experiences showed that inhibition of neointimal hyperplasia may be obtained by local administration of anti-proliferative drugs (like paclitaxel) loaded on the surface of angioplasty balloons. Accordingly, drug-eluting balloons (DEBs) are a promising tool to prevent restenosis and avoid the undesiderable persistence of polymer molecules of DES in the vessel wall, thus potentially increasing the safety of PCI Data on the efficacy of novel coronary DEBs and on the best technique to use them are lacking.
Optical coherence tomography (OCT), has a resolution of 5-10 μm, 10 times higher than intravascular ultrasound, thus allowing fine characterization of stent strut coverage and apposition and detection of minimal degree of in-stent neointima hyperplasia.
Objective of the study:
- To evaluate the degree of neointimal hyperplasia in patients undergoing bare-metal stent (BMS) implantation alone compared to those receiving additional DEB use.
- To assess if the technique of DEB use (pre-dilation or post-dilation) may affect the degree of neointimal hyperplasia after BMS implantation.
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
- 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
- •Non-diabetic patients with a stable coronary artery disease, undergoing elective PCI with BMS
- •de novo non-complex lesions (no bifurcation lesions, no chronic total occlusions, no severe calcifications, no moderate-to-severe tortuosities) located in straight coronary segments.
- •lesion length ≥10 mm and <25 mm.
- •vessel size requiring a single stent with diameter between 3.0 and 3.5mm.
排除标准
- •age <18 years or impossibility to give informed consent,
- •diabetes mellitus
- •female sex with child-bearing potential,
- •life expectancy less than 6 months or any condition impeding clinical follow-up (no fixed address, etc),
- •significant platelet count alteration (<100,000 cells/mm3 or > 700,000 cells/mm3),
- •gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks,
- •participation to another study with any investigational device or drug within which is still in the active phase.
- •history of clotting pathology, known hypersensitivity to aspirin, heparin, cobalt- chromium, paclitaxel, contrast dye,
- •renal failure with creatinine value > 2.5 mg/dl,
- •poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%
- •acute myocardial infarction within the past 48 hours.
- •non ST-elevation acute coronary syndrome
- •Angiographic:
- •left main coronary artery disease,
- •lesions in coronary artery bypass grafts,
- •no suitable anatomy for OCT scan
- •bifurcation lesions, chronic total occlusions, severe calcifications, moderate-to-severe tortuosities
- •presence of additional non target lesions requiring treatment, within and outside the target vessel, which are not successfully treated (non target lesions must be treated prior to the target lesion)
结局指标
主要结局
Primary Endpoint: Neo-intimal area (mm²).
时间窗: 6 months post procedure
次要结局
- Secondary Endpoints: - 6m percentage of uncovered struts. - 6m percentage of struts with ISA. - 6m percentage of protruding struts.(6 months post procedure)