Drug-coated Balloon Angioplasty for De-novo or in-Stent Restenotic Coronary Lesions: an Optical Coherence Tomography Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- In-segment late lumen loss
研究概览
简要总结
In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. The aim of this study was to investigate the relationship between quantitative and qualitative OCT findings, angiographic and clinical outcomes after PCB for coronary lesions.
详细描述
The paclitaxel drug-coated balloon (DCB) is an emerging device in percutaneous coronary intervention (PCI); it allows a rapid local release of an anti-restenotic drug without the use of a durable polymer or metal scaffold. The DCB has been proven to be effective with paclitaxel in preclinical trials and in clinical practice for the treatment of coronary lesions such as in-stent restenosis (ISR), de novo and bifurcation lesions. Optical coherence tomography (OCT) is an intravascular imaging modality that has higher resolution than intravascular ultrasound. Excellent contrast among lumen, vessel, and stent in OCT images allows accurate measurement of lumen and lesion. However, only a few studies have investigated the effect of DCB on the intimal lumen in the acute phase and during the follow-up using optical coherence tomography (OCT). In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization.
Demographic, angiographic, and procedural data were collected. Participants were followed up with coronary angiography and OCT for at least 6-9 months, combined with OCT to analyze qualitative analysis of changes in plaque characterization, and late lumen loss. The participants were followed up for long-term clinical events (including cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary angiography shows that at least one coronary artery has a diameter stenosis >70% (left main stem diameter stenosis>50%)
- •Stable or unstable angina
- •Availability for follow-up for up to 12 months
排除标准
- •Acute myocardial infarction within 48 hours
- •Severe calcified lesions
- •Unable to tolerate dual antiplatelet treatment (DAPT)
- •Severe abnormal hematopoietic system, such as platelet count of < 100×109/L or > 700×109/L and white blood cell count of < 3×109/L
- •Active bleeding or bleeding tendency
- •Severe coexisting conditions, such as severe renal insufficiency (GFR < 60 ml/min•1.73m2), severe hepatic dysfunction [elevated ALT (glutamicpyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
- •Life expectancy < 12 months
- •Pregnancy or planning pregnancy
- •Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
- •Participation or planning to participate in another clinical trial during the same period
- •Refusal to comply with the study protocol
结局指标
主要结局
In-segment late lumen loss
时间窗: 6 months
Changes to lumen area assessed with the use of OCT
次要结局
- Target lesion failure(6 months)