Randomized Comparison of the Biolimus-eluting Biomatrix Neoflex™ og Everolimus-eluting SYNERGY™ Stents in All-comer Patients With Ischemic Heart Disease - The OCT SORT-OUT VIII
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Persistent malapposition
研究概览
简要总结
The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.
详细描述
Prospective, open label, single blind, randomized study with inclusion of 160 patients in two equal sized cohorts (A and B). Angiographic follow-up with optical coherence tomography (OCT) is performed at 1 month (Cohort A) and 3 months (Cohort B). Randomization 1:1 to SYNERGY or BioMatrix Neoflex. The Cohorts are included consecutively, Cohort A first.
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
- •Patients >18 years to be treated with one or more drug-eluting stents in a coronary artery at Aarhus University Hospital or Odense University Hospital
排除标准
- •Age <18 years
- •Do not wish to participate
- •Unable to provide written informed consent
- •Domicile outside Denmark
- •Do not speak Danish
- •Inclusion in the SORT-OUT VIII study
- •Inclusion in other stent studies
- •Expected survival <1 year
- •Allergy to aspirin, clopidogrel, prasugrel or ticagrelor
- •Hypersensitivity to everolimus or biolimus
- •The operator wishes to use other DES
- •Reduced renal function; creatinine> 120 mmol / L
- •Only bare metal stent (BMS) implantation
- •Only plain old balloon angioplasty (POBA)
结局指标
主要结局
Persistent malapposition
时间窗: 1 and 3 months
Persistent malapposition: \>2 adjacent struts of at least 1 mm length =1; \>2 mm=2; \>3 mm=3
Acquired malapposition
时间窗: 1 and 3 months
Acquired malapposition: \>2 adjacent struts of at least 1 mm length =2; \> 2 mm=4; \> 3 mm=6
Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts
时间窗: 1 and 3 months
Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0
Neointimal thickness in one frame or lumen mean diameter stenosis
时间窗: 1 and 3 months
Neointimal thickness in one frame or lumen mean diameter stenosis \>200=1; \>300=2; \>400=3 or diameter stenosis \>50%=4; \>75%=5
Cumulated extra stent lumen increase in matched cross sectional analysis
时间窗: 1 and 3 months
Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)
Coronary Stent Healing Index
时间窗: 1 or 3 months
Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)
Uncovered stent struts
时间窗: 1 or 3 months
Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9
次要结局
- Area stenosis (AS) %(Baseline, 1 and 3 months)
- Fracture(Baseline, 1 and 3 months)
- Malapposition(Baseline, 1 and 3 months)
- Lumen area(Baseline, 1 and 3 months)
- All-cause death(12, 24, 36, 48 and 60 months)
- Device success rate(Baseline)
- Coverage(Baseline, 1 and 3 months)
- Neointimal thickness (NIT)(Baseline, 1 and 3 months)
- Stent area(Baseline, 1 and 3 months)
- Extra stent lumen(Baseline, 1 and 3 months)
- Evaginations(Baseline, 1 and 3 months)
- Stent thrombosis(Baseline, 1, 12, 24, 36, 48 and 60 months)
- Lumen late loss(Baseline, 1 and 3 months)
- Minimum expansion of the stent(Baseline, 1 and 3 months)
- Late recoil(Baseline, 1 and 3 months)
- Target Lesion Failure (TLF)(Within 12 months)
- Thrombus on struts(Baseline, 1 and 3 months)
- Target Lesion Revascularisation (TLR)(Baseline and within 12, 24, 36, 48 and 60 months)
- Acute expansion and late recoil(Baseline, 1 and 3 months)
- Cardiac death(Baseline, 12, 24, 36, 48 and 60 months)
- Non-index procedure related acute myocardial infarction (AMI)(Baseline and within 12, 24, 36, 48 and 60 months)
- Procedural success rate(Baseline)
研究者
Evald Hoej Christiansen
MD, phd
Aarhus University Hospital Skejby