PercutAneous INTervention With Biodegradable- Polymer Based Paclitaxel-eluting, Sirolimus-eluting, or Bare Stents for the Treatment of de Novo Coronary Lesions.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 11
- 主要终点
- compare the in-stent late loss at 9M of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
研究概览
简要总结
Objectives:
PRIMARY OBJECTIVE:
To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
SECONDARY OBJECTIVES:
Safety:
To compare the occurrence of Major Adverse Cardiac Events (MACE) at 30 days, 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.
To compare the occurrence de Serious Adverse Events (SAEs) within 5 years among the paclitaxel, sirolimus and control study arms.
To compare the occurrence of in-stent thrombosis within 5 years among the paclitaxel, sirolimus and control study arms.
Efficacy:
To compare the rate of angiographic success among the study groups To compare the rate of procedural success among the study groups To compare the incidence of clinically driven target lesion revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.
To compare the incidence of clinically driven target vessel revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.
To compare the 1-year, 3-year and 5-year cost-effectiveness profile of the paclitaxel, sirolimus and control study arms.
To compare the 9-month in-stent late loss of paclitaxel-eluting stents to the in-stent late loss of sirolimus-eluting stents To compare the 9-month in-segment late loss among the study groups To compare the 9-month in-stent and in-segment binary restenosis rate among the study groups To compare the IVUS percent neointimal obstruction among the study groups
Study Design:
In the present RANDOMIZED study, the paclitaxel-eluting stent Infinnium® and the sirolimus-eluting stent Supralimus® will be compared to a metallic stent with the same structure (Milennium Matrix®) but without drug elution for the treatment of de novo lesions in native coronaries. The study will be a multicenter clinical trial and will include patients for the treatment with one of the three study stents. In total, 275 patients will be enrolled, randomly allocated for the Infinnium®, Supralimus®, or Milennium Matrix® stents in a 2:2:1 proportion. Patients will be followed-up for 12 months after the index procedure. All patients will undergo a follow-up angiography at 9 months. A subgroup of 55 patients will be evaluated at 9 months with IVUS examination.
Treatment:
Patients will be treated, according to the randomization groups, with Infinnium®, Supralimus®, or Milennium Matrix® stents of 19 mm, 23 mm, or 29 mm and nominal diameters of 2.5, 3.0, and 3.5 mm.
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
- •Age ≥ 18 years;
- •Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia;
- •De novo coronary lesion (non-restenosis);
- •Target lesion located in a native artery;
- •Target lesion located in a vessel with diameter between 2.5-3.5 mm (visual analysis);
- •Target lesion amenable to treatment with a single stent of up to 29 mm in length;
- •Target lesion with a diameter stenosis > 50% (visual analysis);
- •Acceptable candidate for surgical revascularization;
- •Signed informed consent term.
排除标准
- •GENERAL EXCLUSION CRITERIA
- •Q-wave myocardial infarction < 48 hours before the index procedure
- •Recent myocardial infarction, with or without Q waves, with cardiac markers levels still above the normal upper limits
- •Left ventricle ejection fraction ≤30%
- •Renal dysfunction (serum creatinine > 2.0 mg/dl [>177 µmol/l])
- •Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3
- •White cell count < 3.000 cells/mm3
- •Suspected or known liver disease (including subclinical hepatitis)
- •Heart transplant recipient
- •Know allergy to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin, or stainless steel
- •Life expectancy < 12 months
- •Any medical condition that, in the opinion of the investigator, may interfere with the ideal participation in study
- •Current inclusion in another study to investigate drug or other device, or planned inclusion in another study to investigate drug or other device during the follow-up.
- •Coronary angioplasty (with or without stent) < 6 months in any segment of the target vessel
- •Previous coronary angioplasty (with or without stent), at any time, in a coronary segment < 5 mm (proximal or distal) from the target lesion
- •Coronary angioplasty (with or without stent) in any segment of the target vessel planned during the next 12 months following the index procedure.
- •ANGIOGRAPHIC EXCLUSION CRITERIA
- •Restenotic target lesion
- •Need for treatment of more than one lesion in the target vessel;
- •Diameter of the target vessel < 2.5 mm or > 3.5 mm (visual analysis)
- •Long target lesion, not amenable to treatment with a single stent of up to 29 mm in length, according to the operator's discretion
- •Significant (> 50%) unprotected left main lesion
- •Angiographic thrombus
- •Target lesion located in bypass graft
- •Occluded target vessel (antegrade flow TIMI 0 or 1)
- •Target lesion in ostial location;
- •Target lesion in a bifurcation site with a side branch > 2.5 mm or that may require stent implantation;
- •Calcified target lesion with anticipated unsuccessful balloon pre-dilatation;
- •Severely tortuous target vessel.
研究组 & 干预措施
1
Percutaneous coronary intervention with bare metal stent
干预措施: Milennium Matrix® (Control) (Device)
2
Percutaneous coronary intervention with paclitaxel-eluting stent
干预措施: Infinnium® (Device)
3
Percutaneous coronary intervention with sirolimus-eluting stent
干预措施: Supralimus® (Device)
结局指标
主要结局
compare the in-stent late loss at 9M of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
时间窗: 9 months
次要结局
- MACE at 1,9&12M, SAE & ST until 12M. Rate of angiographic & procedural success, TLR & TVR at 1&9M Instent LL between Supralimus®, Infinnium® & Matrix® Insegment binary restenosis at 9M IVUS% neointimal obstruction cost-effectiveness profile at 12M(1 Year)