Evaluation of Microcirculatory Protection In Percutaneous REvascularisation With Bioresorbable Vascular Scaffolds Versus Metallic Drug-eluting Stents: a Device- and Implant Technique-based Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in IMR between baseline and post-stent/scaffold implantation.
研究概览
简要总结
Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels) supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty). Traditionally, stents are constructed from metal and are permanent. However, newer stents are being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over time leaving no permanent implant. New data has suggested that these scaffolds appear to reduce recurrent angina and may alter the blood flow down the artery. However, it is not known whether this is due to the scaffolds themselves or the way the scaffolds are inserted. In this study we hope to measure the blood flow to the heart and assess changes in that flow during stent and scaffold insertion. It is also important to know whether these effects are durable and thus, a cohort of patients will return at 3-months to be restudied. These data are important to help us understand why blood flow is affected by stent/scaffold selection or device implantation technique and whether this results in better long-term outcomes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age >18 years, <75 years.
- •Lesion suitability for BVS deployment: target vessel calibre >2.3mm and <3.8mm reference diameter, without significant tortuosity or calcification.
- •Listed for single-vessel PCI procedure.
- •Lesion length≤28mm (to accommodate single BVS/DES)
- •Preserved left ventricular ejection fraction (EF≥50%).
排除标准
- •Patients with confirmed myocardial infarction within the preceding 2 months.
- •Allergy or intolerance to aspirin, clopidogrel, prasugrel or ticagrelor or contraindication to 12 months' dual antiplatelet therapy.
- •Contraindication to use of adenosine (asthma/chronic lung disease with documented bronchoreactivity).
- •Significant known comorbidity or terminal condition with life expectancy <6 months.
- •Coagulopathy or warfarin treatment.
- •Significant renal impairment (baseline creatinine>130 mmol/l).
- •Other comorbid condition that may affect microcirculatory function or troponin release (eg. Seropositive inflammatory conditions).
- •Inability to comply with follow-up requirements.
- •Target lesion in left mainstem, saphenous vein or arterial grafts.
- •Chronic total occlusion.
研究组 & 干预措施
DES-std group
(DES: drug-eluting stent). Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.
干预措施: Drug-Eluting Stent (DES) - standard(std) (Device)
DES-slow group
(DES: drug-eluting stent). Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage.
After the interim analysis DES-slow to be compared with BVS.
干预措施: Drug-Eluting Stent (DES) - slow (Device)
BVS group
(Bioresorbable Vascular Scaffold) Introduced after the interim analysis (phase 2) for comparison with DES-slow.
干预措施: Bioresorbable Vascular Scaffolds (BVS) (Device)
结局指标
主要结局
Change in IMR between baseline and post-stent/scaffold implantation.
时间窗: During procedure
IMR: index of microvascular resistance
Change in CFR between baseline and post-stent/scaffold implantation.
时间窗: During procedure
CFR: coronary flow reserve
次要结局
- Serious adverse events(At time points 1, 3, 6 & 12 months post-PCI)
- Incidence of troponin elevation post-PCI (MI4a).(Measured 6 hours after stent insertion)
- Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.(3 months follow up)
- Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.(During index procedure and at 3 month follow up)
- Adverse events(At time points 1, 3, 6 & 12 months post-PCI)
- Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.(During index procedure and at 3 month follow up)
- Nature/phenotype of underlying target lesion plaque by OCT analysis.(During index procedure and at 3 month follow up)
- Incidence of post-PCI angina and quality of life by standardized Seattle angina questionnaire at telephone follow-up.(Up to 12 months)