Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Multislice computed tomography
研究概览
简要总结
Patients presenting with acute ST elevation myocardial infarct urgently need revascularization. Standard of care is establishing bloodflow through the coronary vessels using thrombus aspiration catheter, and securing the result by using a metallic drug eluting stent. New kinds of non-metallic bioresorbable stents are now available. They have however challenges in structural strength.
The investigators want to compare the new bioresorbable scaffold with traditional metallic stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120 patients. The investigators will use an imaging technique, optical coherence tomography, to evaluate the results after 12 months.
The investigators also want to see if modern multislice computed tomography can give useful information in the follow-up of stented coronary arteries after 12 and 24 months.
详细描述
Patients presenting with ST elevation myocardial infarction for primary PCI (percutaneous coronary intervention) will be screened. After thrombus aspiration, patient will be asked for oral consent if TIMI flow 2-3. Patient will then be randomized between drug eluting stent (Xience pro, Abbott Vascular Solutions) and bioresorbable scaffold (Absorb, Abbott Vascular Solutions). Optical coherence tomography (OCT) will be performed before stenting and after final result. Stent will be deployed without further predilatation if possible. Follow up at 12 months (clinical, angio with OCT and multislice CT coronary angiogram (MSCT-CA)) and 24 months (MSCT-CA).
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
- •History of chest pain < 12 hrs
- •ST elevation of ≥ 2 mm in ≥2 contiguous precordial leads (V1-V6), and/or ≥ 1 mm in ≥ 2 contiguous standard leads (I, II, III, aVf, aVr,aVl).
- •Clinical decision to treat with primary PCI
- •> 18 years
- •Oral informed consent
排除标准
- •Contraindications to long term double antiplatelet therapy
- •Known kidney failure with GFR < 45
- •Cardiac arrest or severe cardiogenic shock (Persistent BP <90 mmHg, despite adequate treatment)
- •Other severe illness with life expectancy of less than 12 months (eg. malignancy, severe malnutrition, degenerative disease)
- •Procedural contraindications:
- •Heavy calcification, tortuous vessel or large side branch (> 2,5 mm) at culprit lesion.
- •TIMI 0-1 flow after aspiration
- •Unable to advance thrombus aspiration catheter
结局指标
主要结局
Multislice computed tomography
时间窗: 24 months
MSCT-CA will be done at 24 months to extend the observational time by a non-invasive measure. MSCT-CA will be compared to conventional angiogram with OCT at 12 months to verify MSCT-CA findings at 24 months. Results will be reported in separate paper.
Minimum Flow Area
时间窗: 12 months
Minimum flow area as defined in TROFI I, measured by OCT
Coronary Stent Healing Index (cumulated)
时间窗: 12 months
1. Uncovered struts: 2% =1 - 5% =2 - 10% =3 - 15% =4 - 20% =5 - 25% =6 - 30% =7 - 35% =8 - 40% =9 2. Uncovered struts in front of side branch on acquired or persistent malposed struts. 10% =1 - 20% =2 - 30% =3 etc... til 100%=10 3. Persistent malposition: ≥2 nabo struts længde mindst 1 mm =1 ; ≥2mm=3 ; ≥3 mm = 3 4. Acquired malposition: ≥2 adjacent struts of at least 1 mm length =2 ; ≥2mm=4 ; ≥3 mm = 6 5. Neointimal thickness in one frame \>200 =1 - \>300 =2 - \>400 =3 or diameter stenosis \>50% =4 - \> 75% =5 6. Cumulated extra stent lumen increase in match cross sectional analysis: (gns. areal mål): ≥0.2mm2 =1 ; ≥0.4 mm2 = 2; ≥0.6mm2=3 ; ≥0.8 mm2 = 4 ; ≥1.0 mm2=5 ; ≥1.2 mm2 = 6
次要结局
- Target Lesion and vessel Revascularization(5 years)
- Stable angina(5 years)
- Total Death(5 years)
- Stent thrombosis(5 years)
- Non Target vessel revascularisation(5 years)
- Cardiac death(5 years)
- Admission for congestive heart failure or arrhythmias(5 years)
- Thrombus analysis(At index procedure were the patient is included and randomized)
- Myocardial infarction(5 years)
- Optical Coherence tomography(12 months)
- Biochemical(12 months)
- Markers(12 months)
- Vascular cerebral events(5 years)
- Angiographic endpoints at index admission(After index procedure were the patient is included and randomized)
- Optical coherence tomography(12 months)