Randomized Study to Evaluate Segmental Late Loss Comparing Two PCI Strategies Using a Long Stent vs 2 Shorter Stents to Treat Long or Tandem Coronary Stenosis.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- follow up in-stent late lumen loss
研究概览
简要总结
Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long coronary stenoses but this strategy is expensive and the response to overlapping DES has not been extensively studied. The recent availability of bioabsorbable polymer DES could allow treatment of long coronary stenoses without leaving gross burden of non-absorbable polymer in the vessel wall, even in case of overlapping stents.
Thus we planned to evaluate which of the 2 strategies, namely using a single long biabsorbable DES or two shorter biabsorbable DES with minimal overlapping, is better in treating long coronary stenoses.
The study is a spontanous randomized multicenter open-label study. A maximum of 300 patients with stable angina and at leat 1 coronary stenosis >28mm and <40mm of length will be randomized in 1:1 fashion by a Web-based electronic CRF. The long stent group (Group A) will be treated by a single 44mm Biomime DES (II generation DES with bioabsorbable polymer, Meril Life Sciences Pvt. Ltd., Gujarat, India). The short stent group (Group B) will be treated by 2 short Biomime DES positioned with minimal overlapping. The primary end-point of the study will be the 6 moth in-stent late lumen loss. Seconadry end-points will be 1, 6 and 12 month overall mortality, myocardial infarction, target vessel revascularization, stent thrombosis and MACE (combination of the 3 previous clinical end-points). Patients will be evaluated by 6-month control coronary angiography and late lumen loss in the stented vessel will be measured in a quantitative coronary angiography Core Lab (Cardioimaging Centre, Novara, Italy)
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
- •De novo coronary artery stenosis in a major coronary artery branch (reference diameter 2.5-4.0 mm) with a lenght >28mm and <39mm
- •Symptoms or instrumental evidence of myocardial ischemia:
- •Chronic stable angina [Canadian Cardiovascular Society Classification]
- •Unstable angina with ECG changes or troponin release (Braunwald Class IB-C, IIB-C, or IIIB-C)
- •Stress ECG or myocardial perfusion imaging or stress echocardiography positive for inducible myocardial ischemia
- •Written informed consent to the study
排除标准
- •Pregnancy or lactation
- •Acute ST elevation myocardial infarction (primary angioplasty)
- •Cardiogenic shock
- •Known allergic reactions to aspirin, clopidogrel, prasugrel, heparin, enoxaparin, bivalirudin, steel, chromium, iodiate contrast medium
- •Platelets <75.000/mm3 or >700.000/mm3 or white blood cells <3.000/mm
- •Partecipation to other studies.
- •Active or <3 months peptic ulcer or gastrointestinal bleeding
- •Planned major surgery non delayable .
- •Comorbidities limiting life expectancy to <1 year.
- •Unprotected left main disease as target lesion
- •Chronic total occlusion as target lesion
- •Bifurcation with side branch > 2.5mm as target lesion
- •Restenosis as target lesion
- •saphenous vein graft as target lesion.
研究组 & 干预措施
Single long bioabsorbable polymer DES
Patients with long coronary stenosis treated by a single long bioabsorbable polymer DES
干预措施: implantation of a bioabsorbable polymer DES (Device)
Two bioabsorbable polymer DES in overlapping
patients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping
干预措施: implantation of a bioabsorbable polymer DES (Device)
结局指标
主要结局
follow up in-stent late lumen loss
时间窗: 6-month
difference between the in-stent coronary lumen measure obtained immediately after coronary percutaneous intervention and the in-stent coronary lumen measure at follow up
次要结局
- Stent thrombosis(2 years)
- overall mortality(1 year)
- Myocardial infarction(1 year)
- target vessel revascularization(1 year)
- MACE (major coronary adverse event)(1 year)
研究者
Lupi Alessandro
Dr Alessandro Lupi, Cardiologia Ospedaliera, AOU Maggiore della Carità, Novara.
Azienda Ospedaliero Universitaria Maggiore della Carita