Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 28
- 主要终点
- Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
研究概览
简要总结
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patient has evidence of myocardial ischemia or a positive functional study
- •Target lesion has a visually estimated stenosis of ≥50% and <100%
- •Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.5mm and ≤ 3.5mm
- •Lesion length ≤ 20 mm by visual estimate (N/A for Cohort C)
- •Baseline TIMI flow ≥ 2
排除标准
- •The patient has experienced an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within 2X ULN.
- •Patient has a left ventricular ejection fraction < 40%
- •Patient has unprotected left main coronary disease with ≥50% stenosis
- •The target vessel is totally occluded (TIMI Flow 0 or 1)
- •Target lesion involves a bifurcation (a lesion with a side branch ≥ 1.5 mm in diameter containing a ≥ 50% stenosis).
- •Target lesion is located within a bypass graft
- •Target lesion has possible or definite thrombus
研究组 & 干预措施
Cohort A
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
干预措施: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold (Device)
Cohort B
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
干预措施: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold (Device)
Cohort C
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel
干预措施: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold (Device)
结局指标
主要结局
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
时间窗: 6 months
Late Lumen Loss
Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
时间窗: 6 months
Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB \>5X ULN) (MI), and target lesion revascularization (TLR)
次要结局
- Target Lesion Revascularization (TLR) - Cohorts A, B and C(12, 24, 36, 48 and 60 months)
- Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C(6 months)
- Quantitative Coronary Angiography (QCA) derived parameters - Cohort B(9 months)
- Target Vessel Failure (TVF) - Cohorts A, B and C(12, 24, 36, 48 and 60 months)
- Acute Technical Success - Cohorts A, B and C(Day 0)
- Major Adverse Cardiac Events (MACE) - Cohorts A, B and C(12, 24, 36, 48 and 60 months)
- Target Vessel Revascularization (TVR) - Cohorts A, B and C(12, 24, 36, 48 and 60 months)
- Procedural Success - Cohorts A, B and C(30 days)