Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Minimum stent area post-stenting measured by optimal coherence tomography (OCT)
研究概览
简要总结
Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. Notwithstanding, stent-related events yet occur.
Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions
详细描述
The study will be a prospective, multicenter, randomized controlled trial in patients undergoing PCI with the novo coronary disease.
A total of 96 patients with de novo coronary artery stenosis will be included.
After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Random allocation in a 1:1 fashion to one of the following strategies:
A) Study group: Pre-dilation with cutting balloon followed by ASES implantation.
B) Control group: Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses >50% in a native coronary artery.
排除标准
- •Cardiogenic shock
- •Patients presenting with ST-segment elevation myocardial infarction
- •Patients undergoing chronic total occlusions PCI
- •Patients undergoing left main PCI
- •Patients undergoing venous bypass graft lesions PCI
- •Patients with in-stent restenosis
- •Inability to provide informed consent
- •Life expectancy <1year due to non-cardiac disease
- •Currently participating in another trial before reaching first endpoint
- •There will be no exclusion based on mode of co-morbidities, left ventricular function, number of diseased vessels and lesions, or number of target lesions.
研究组 & 干预措施
Study group
Pre-dilation with cutting balloon followed by ASES implantation.
干预措施: Predilation with cutting balloon. (Device)
Control group
Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.
干预措施: Predilation with conventional balloon (Device)
结局指标
主要结局
Minimum stent area post-stenting measured by optimal coherence tomography (OCT)
时间窗: Immediately after the procedure
次要结局
- Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT).(9 month follow-up.)
- Mean stent area measured by optimal coherence tomography(9 month follow-up.)
- Malapposition (Major/minor) post-stenting measured by optimal coherence tomography(Immediately after the procedure and at 9 month follow-up)
- Mean neointimal hyperplasia area measured by optimal coherence tomography(9 months)
- Death from cardiovascular causes(12 months)
- Target vessel myocardial infarction(12 months)
- Target lesion revascularization(12 months)
- Stent thrombosis(12 months)
- Acute procedural success(Immediately after the procedure)
- Coronary disection(Immediately after the procedure)
- Minimum stent eccentricity measured by optimal coherence tomography(9 months)
- Stent asymmetry index measured by optimal coherence tomography(9 months)
- All cause death(12 months)
- Any myocardial infarction(12 months)
研究者
Jorge Sanz Sanchez
Specialist in Cardiology, MD, PhD
Hospital Universitario La Fe