Vascular Healing Pattern, Vasoreactivity, and Quality of Life in Patients With ST Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention With Sirolimus Eluting FANTOM Bioresorbable Vascular Scaffold With Long Term Clinical, Near Infrared Spectroscopy and Optical Coherence Tomography Follow-up: A FANTOM STEMI Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Procedural success defined as acute angiographic success (residual stenosis <20% and TIMI flow 3) without in-hospital major adverse cardiac events (MACE)
研究概览
简要总结
The study will assess the safety and performance of the Fantom sirolimus eluting bioresorbable vascular scaffold (BVS) in the acute setting of myocardial infarction with unstable lesions and thrombogenic milieu.This is a prospective evaluation of clinical and patient related measures in STEMI patient who undergo urgent primary percutaneous coronary intervention (PCI) with stent implantation. Patients with culprit lesions with 2.5 - 3.5 mm diameter and located in one of the main coronary arteries will be included in the trial and prospectively observed. The study will comprise 20 patients, who will undergo additional evaluation with optical coherence tomography (OCT) and near-infrared spectroscopy/intravascular ultrasound (NIRS/IVUS) at baseline, 6 months, 18-24 months and 36 months. The device will be delivered in sizes 2.5 and 3.0 in diameter / 18 and 24 mm and 3.5 mm x 18 mm in length.
详细描述
The aim of the study is to evaluate the acute safety and feasibility of implantation of the sirolimus-eluting bioresorbable Fantom scaffold BVS in the setting of ST segment elevation myocardial infarction (STEMI), as well as the mid and long-term clinical efficacy and healing pattern of the device, the plaque modification and patient related outcomes, including quality of life and patient preferences.
Primary end-point
- Procedural success defined as acute angiographic success (residual stenosis <20% and Thrombolysis In Myocardial Infarction (TIMI) flow 3) without in-hospital major adverse cardiac events (MACE) (19) Secondary end-points
- Angiographic success defined as device implantation into target lesion with residual stenosis of < 20% and presence of grade 3 TIMI flow assessed by angiography. (19)
- Quantitative coronary angiographic measurements including minimum lumen diameter (mm), diameter stenosis (%), late lumen loss (mm), evaluated post-procedure, at 6, 18 and 36 months
- OCT measurements at patient level including mean lumen area (mm2), mean scaffold area (mm2), mean vessel area (mm2), mean/min./max. neointima thickness (μm), neointima area (mm2), scaffold area obstruction (%), symmetry of the neointima thickness, malposed strut ratio (%), malposed strut total (n), mean malposition distance (mm), malposition area (mm2) evaluated post-procedure, at 6, 18 and 36 months (16)
- OCT measurements at scaffold level including mean lumen area (mm2), mean scaffold area (mm2), mean vessel area (mm2), mean/min./max. neointima thickness (μm), neointima area (mm2), scaffold area obstruction (%), symmetry of the neointima thickness, malposed strut ratio (%), malposed strut total (n), mean malposition distance (mm), malposition area (mm2) evaluated post-procedure, at 12, 24 and 36 months (16)
- NIRS assessment including: number of blocks/region of interest, block hemogram value, block hemogram colors [red (p < 0.57), orange (0.57 ≤ p < 0.84), tan (0.84 ≤ p < 0.98) and yellow (p ≥ 0.98)]. (20)
- IVUS assessment including: mean lumen area (mm2), mean vessel area (mm2), mean scaffold area (mm2), mean plaque area (mm2), plaque volume (mm3), calcification volume (mm3), hyperechogenicity (mm3 and %).
- Coronary response expressed as percent change from baseline of the acetylcholine- and nitroglycerine-induced change in mean lumen diameter.
- Device-oriented composite end-point as defined by Academic Research Consortium, consisting of cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), target lesion revascularization at 6, 18 and 36 months. (21)
- Patient-oriented composite end-point as defined by Academic Research Consortium, consisting of all-cause mortality, any myocardial infarction (including non-target vessel territory) and repeat revascularization (includes all target and nontarget vessel) at 6, 18 and 36 months. (21)
- Quality of life assessed by generic and specific cardiology psychology tools (QLI, MacNew, EQ-5D) validated in coronary artery disease patients (especially related to angina) at 6, 18 and 36 months.
Study design
The study will assess the safety and performance of the Fantom sirolimus eluting BVS in the acute setting of myocardial infarction with unstable lesions and thrombogenic milieu.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •• Electrocardiographic confirmation of acute coronary syndrome with ST segment elevation (according to the 2012 European Society of Cardiology guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation) or high-risk non-ST segment elevation patients in whom urgent reperfusion strategy is applied.
- •Symptom onset to balloon inflation time <12 hours
- •Age >18 years
- •The patient's written informed consent has been obtained prior to the procedure.
- •Each lesion must meet all the following baseline criteria (prior to pre-dilation):
- •De novo lesion in a native coronary artery.
- •Visually estimated stenosis of at least 50%.
- •Visually estimated RVD ≥2.5 mm and ≤3.5 mm (RVD defined as mean of proximal and distal RVD)
- •Lesion length:
- •20 mm by visual estimate for single scaffold implantation
- •Each lesion must meet all the following criteria after pre-dilatation:
- •Target vessel reference diameter ≤3.5 mm by visual assessment.
- •Lesion length:
- •20 mm by visual estimate for single scaffold implantation
排除标准
- •Candidates will be excluded from the trial if ANY of the following exclusion criteria are met:
- •A. Clinical
- •Cardiogenic shock or pulmonary edema
- •Known hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparins, abciximab, everolimus, or polylactide
- •Hypersensitivity to contrast agents
- •Concomitant diseases resulting in significantly worse long-term prognosis
- •Acute and chronic inflammatory conditions
- •Lack of patient consent
- •Acute mechanical complications of myocardial infarction
- •Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization.
- •Fibrinolysis prior to PCI.
- •Active bleeding or coagulopathy or patient at chronic anticoagulation therapy
- •Life expectancy less then 12 months.
- •Patient has a scheduled surgery or another contraindications that may preclude 12-month dual antiplatelet therapy.
- •Subject participating in an other trial B. Angiographic
- •Significant left main coronary artery stenosis
- •Multivessel disease requiring coronary artery bypass grafting (MVD scheduled for percutaneous treatment is not considered as an exclusion criteria).
- •Culprit lesion location within a true bifurcation with a large side branch (vessel lumen diameter >2.0 mm)
- •Presence of massive calcifications seen within the vessel contour or identified using intracoronary imaging techniques
- •Lesion within a vein bypass graft
- •Lesions located within 3 mm from vessel origin
- •Target lesion located within previously stented region
- •Anatomic location and lesion morphology precluding an optimal effect of percutaneous coronary intervention (PCI) or imaging by OCT in the opinion of the investigator
- •Excessive proximal tortuosity
- •Vessel diameter <2.5 mm and > 3.5 mm
研究组 & 干预措施
Intervention
Patient diagnosed with ST elevation myocardial infarction will undergo bioresorbable stent deployment in culprit lesion.
干预措施: PCI with Phantom Bioresorbable Scaffold (Device)
结局指标
主要结局
Procedural success defined as acute angiographic success (residual stenosis <20% and TIMI flow 3) without in-hospital major adverse cardiac events (MACE)
时间窗: From time of procedure until the date of discharge from hospital assessed up to 30 days
次要结局
- OCT measurements at patient level evaluated post-procedure, at 6, 18 and 36 months.(3 years)
- Angiographic success defined as device implantation into target lesion with residual stenosis of < 20% and presence of grade 3 TIMI flow assessed by angiography(3 years)
- Quantitative coronary angiographic measurements including diameter stenosis (%) at 6, 18 and 36 months(3 years)
- Quantitative coronary angiographic measurements including minimum lumen diameter (mm), late lumen loss (mm) evaluated post-procedure at 6, 18 and 36 months(3 years)
研究者
Łukasz Kołtowski
Adjunct Prof., MD, PhD
Medical University of Warsaw