Six-month Endothelial and Microcirculatory Function of the Bioactive Sirolimus-eluting Combo Stent Versus the Polymer-free Biolimus-eluting Biofreedom Stent in Patients With ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Endothelial function of the distal coronary segment of patients with myocardial infarction treated with two types of drug-eluting stents
研究概览
简要总结
A total of 50 patients with ST-elevation myocardial infarction (STEMI) undergoing primary-percutaneous coronary intervention (PPCI) will be randomized to two different coronary stents: BIOFREEDOM vs. COMBO stent.
All patients will undergo to 6-month scheduled coronary angiography to evaluate the endothelial function response of the distal coronary segment and other functional parameters.
详细描述
The bioengineered COMBO stent (Orbus Neich, Fort Lauderdale, Florida, United States) has a dual-therapy strategy, which combines a sirolimus-eluting coating with an anti-CD34 antibody layer to promote vessel healing. Sirolimus release (5 μg/mm) is completed in 30 days, and the biodegradable polymer disappears within 90 days.
CD34 antibodies are immobilized on the surface of the stent and capture circulating endothelial progenitor cells (EPCs). The captured EPCs are triggered by sheer stress from the circulating blood and other cell signals to differentiate and mature into endothelial cells. COMBO Plus is the only stent with a biological coating that actively repairs the vessel morphology. However, little is known regarding the endothelial function after stent 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
- Single (Participant)
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
- •STEMI < 12 hours undergoing primary PCI.
- •ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguous anterior leads.
- •Presence of at least one acute infarct artery target vessel with one or more de-novo coronary artery stenosis in a native coronary artery within 2.75 - 3.75 mm reference vessel diameter and < 24 mm length (visually estimated).
排除标准
- •Inability to provide informed consent
- •Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
- •Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material
- •Cardiogenic Shock
- •Unprotected left main coronary artery stenosis
- •Distal occlusion of target vessel
- •Acute myocardial infarction secondary to stent thrombosis
- •Mechanical complications of acute myocardial infarction
- •Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication in the follow-up procedure
- •Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
- •Chronic renal dysfunction with creatinine clearance < 45 ml/minm2
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
结局指标
主要结局
Endothelial function of the distal coronary segment of patients with myocardial infarction treated with two types of drug-eluting stents
时间窗: At 6 months of the stent implantation
To compare the mean lumen diameter changes to intracoronary acetyl-choline infusion of the distal coronary segment by quantitative coronary angiography between the COMBO stent vs. the BIOFREEDOM stent in STEMI patients. Endothelial dysfunction is defined as \>4% vasoconstriction to intracoronary acetylcholine compared to the 6-month baseline mean lumen diameter of the matched segment.
次要结局
- Index of microcirculatory resistance(At 6 months of the stent implantation)
- Coronary flow reserve(At 6 months of the stent implantation)
研究者
Josep Gomez Lara
Principal Investigator
Institut d'Investigació Biomèdica de Bellvitge