A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Index of adverse vessel wall features by OCT
研究概览
简要总结
The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.
详细描述
Bioresorbable stents 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 investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.
Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and feasible.
Methods:
The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients. Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for clinical endpoints until 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Stabilized non-ST elevation myocardial infarction
- •Silent angina pectoris
- •Age > 18 years
- •De novo coronary bifurcation lesion at LAD/diagonal, CX/obtuse marginal or RCA-PDA/posterolateral branch
- •All Medina classes except Medina x.x.
- •Diameter of side branch ≥ 2.5 mm
- •Side branch diameter stenosis less than 50%
- •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 or GFR < 0.45 mL/min per 1.73 m2
- •Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus
- •Unable to cover main vessel lesion with one stent
- •Severe tortuosity
- •Severe calcification
结局指标
主要结局
Index of adverse vessel wall features by OCT
时间窗: 1 month
Index based on: 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
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
时间窗: 1 month
Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
次要结局
- Angiographic endpoint: Ostial side branch acute gain after main vessel stenting(Baseline)
- Optical coherence tomography endpoint: Acquired malapposition(1 month)
- Optical coherence tomography endpoint: Mean neointimal thickness(1 month)
- Optical coherence tomography endpoint: Extra stent lumen (including evaginations)(Baseline and 1 month)
- Optical coherence tomography endpoint: Late stent recoil(1 month)
- Optical coherence tomography endpoint: Ostial strut loss(Baseline and 1 month)
- Optical coherence tomography endpoint: Persistent malapposition(1 month)
- Optical coherence tomography endpoint: Coverage of jailing struts(1 month)
- Optical coherence tomography endpoint: Stent strut coverage(1 month)
- Optical coherence tomography endpoint: Minimum stent expansion area %(Baseline and 1 month)
- Optical coherence tomography endpoint: Healing above lipid plaque(1 month)
- Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting(Baseline)
- Angiographic endpoint: Proximal main vessel area stenosis(Baseline and 1 month)
- Procedural endpoint: Fluoroscopy time(Intraoperative)
- Optical coherence tomography endpoint: Stent fracture(Baseline and 1 month)
- Optical coherence tomography endpoint: Minimal stent area in segmental analysis(Baseline and 1 month)
- Optical coherence tomography endpoint: Late recoil(1 month)
- Angiographic endpoint: Ostial side branch late loss(1 month)
- Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting(Baseline)
- Procedural endpoint: Contrast use in mL(Intraoperative)
- Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death(60 months)
- Procedural endpoint: Procedure time(Intraoperative)
- Optical coherence tomography endpoint: Acute malapposition(Baseline)
- Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts(Baseline and 1 month)
- Optical coherence tomography endpoint: Minimal luminal area in segmental analysis(Baseline and 1 month)
- Optical coherence tomography endpoint: Healing above calcified plaque(1 month)
- Optical coherence tomography endpoint: Acute thrombus on struts(Baseline)
- Optical coherence tomography endpoint: Acute expansion(Baseline)
- Angiographic endpoint: Ostial distal main vessel area stenosis(Baseline and 1 month)
- Optical coherence tomography endpoint: Segmental area stenosis(Baseline and 1 month)
- Optical coherence tomography endpoint: Late thrombus on struts(1 month)
- Angiographic endpoint: Ostial side branch area stenosis(Baseline and 1 month)
- Angiographic endpoint: Ostial distal main vessel late loss(1 month)
- Angiographic endpoint: Proximal main vessel late loss(1 month)
- Angiographic endpoint: Minimal luminal area of all segments(Baseline and 1 month)
研究者
Evald Hoej Christiansen
Principal investigator (MD, PhD)
Aarhus University Hospital Skejby