Bioresorbable Vascular Stents for Treatment of Coronary Bifurcation Lesions Assessed by Optical Coherence Tomography - The BIFSORB Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
研究概览
简要总结
Coronary artery disease is often treated by implantation of permanent metallic stents.Coronary stents are required in the early healing phase after balloon dilatation but constitute a lifelong foreign body. New bioresorbable stents have been developed and are believed to improve long-term safety. The purpose of this study is to compare the safety and vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable stents Absorb and Desolve.
详细描述
BIFSORB is a prospective, randomized multicenter trial comparing 6-month healing outcome after treatment of simple coronary bifurcation lesions by Absorb or Desolve BRS. for treatment of coronary bifurcation lesions.
BRS are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.
The aim of this study is to compare the 6 months safety and vessel healing after treatment of coronary bifurcation lesions by the Desolve or Absorb BRS.
Hypothesis: Treatment of coronary bifurcation lesions using Absorb and Desolve bioresorbable stents is safe. Treatment of coronary bifurcation lesions by Desolve BRS is associated with a lower index of adverse vessel wall features (main vessel area stenosis, acquired malapposition, evaginations, late recoil, single end attached protruding struts, side branch ostial area stenosis) at 6 months compared to treatment with Absorb BRS.
Methods:
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
- •Stable angina pectoris
- •Age > 18 years
- •Stabilized non-ST elevation myocardial infarction
- •Silent angina
- •De novo coronary bifurcation lesions at LAD/diagonal, CX/obtuse marginal, RCA-PDA/posterolateral branch
- •All Medina classes except Medina x.x.1
- •Diameter of side branch ≥ 2.5 mm
- •Signed informed consent
排除标准
- •ST-elevation infarction within 48 hours
- •Expected survival < 1 year
- •Severe heart failure (NYHA≥III)
- •S-creatinine > 120 µmol/L
- •Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or novolimus
- •Unable to cover main vessel lesion with one scaffold
- •Severe tortuosity
- •Severe calcification
结局指标
主要结局
Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
时间窗: 6 months
Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
Index of adverse vessel wall features
时间窗: 6 months
Side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain
次要结局
- Optical coherence tomography endpoint: Extra stent lumen (including evaginations)(Baseline, 6 and 24 months)
- Optical coherence tomography endpoint: acquired malapposition(6 and 24 months)
- Optical coherence tomography endpoint: persistent malapposition(6 and 24 months)
- Optical coherence tomography endpoint: Stent strut coverage(6 and 24 months)
- Optical coherence tomography endpoint: Healing above lipid plaque(6 and 24 months)
- Optical coherence tomography endpoint: Coverage of jailing struts(6 and 24 months)
- Optical coherence tomography endpoint: Segmental area stenosis(Baseline, 6 and 24 months)
- Angiographic endpoint: Ostial side branch acute gain after main vessel stenting(Baseline)
- Optical coherence tomography endpoint: Late stent recoil(6 and 24 months)
- Optical coherence tomography endpoint: stent fracture(Baseline, 6 and 24 months)
- Optical coherence tomography endpoint: Minimum scaffold expansion area %(Baseline, 6 and 24 months)
- Optical coherence tomography endpoint: acute malapposition(Baseline)
- Optical coherence tomography endpoint: Minimal luminal area in segmental analysis(Baseline, 6 and 24 months)
- Optical coherence tomography endpoint: Minimal stent area in segmental analysis(Baseline, 6 and 24 months)
- Optical coherence tomography endpoint: Healing above calcified plaque(6 and 24 months)
- Optical coherence tomography endpoint: Late thrombus on struts(6 and 24 months)
- Angiographic endpoint: Ostial side branch area stenosis(Baseline, 6 and 24 months)
- Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting(Baseline)
- Angiographic endpoint: Proximal main vessel late loss(6 and 24 months)
- Procedural endpoints: Contrast use(Baseline)
- Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts(Baseline, 6 and 24 months)
- Optical coherence tomography endpoint: Ostial strut loss(Baseline, 6 and 24 months)
- Optical coherence tomography endpoint: Mean neointimal thickness(6 and 24 months)
- Optical coherence tomography endpoint: Acute thrombus on struts(Baseline)
- Optical coherence tomography endpoint: Acute expansion(Baseline)
- Angiographic endpoint: Ostial distal main vessel late loss(6 and 24 months)
- Angiographic endpoint: Proximal main vessel area stenosis(Baseline, 6 and 24 months)
- Procedural endpoints: Procedure time(Baseline)
- Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting(Baseline)
- Optical coherence tomography endpoint:Late recoil(6 and 24 months)
- Angiographic endpoint: Ostial side branch late loss(6 and 24 months)
- Angiographic endpoint: Ostial distal main vessel area stenosis(Baseline, 6 and 24 months)
- Procedural endpoints: Fluoroscopy time(Baseline)
- Angiographic endpoint: Minimal luminal area of all segments(Baseline, 6 and 24 months)
研究者
Evald Hoej Christiansen
Principal investigator (MD, PhD)
Aarhus University Hospital Skejby