NCT05893498进行中（未招募）不适用
Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,924
- 试验地点
- 59
- 主要终点
- MACE
研究概览
简要总结
To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.
详细描述
ALL-RISE is a prospective, randomized, multi-center, controlled post-market study. The ALL-RISE study is designed to test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease being evaluated for percutaneous coronary intervention (PCI) with respect to major adverse cardiac events (MACE) at one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •1. Adult patients (≥18 years of age) with one or more study lesion(s) (diameter stenosis 50-90%) deemed appropriate for both pressure-wire and FFRangio physiologic assessment.
排除标准
- •Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment
- •Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s)
- •Patients undergoing coronary physiologic assessment where one possible outcome is referral for CABG
- •The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
- •Severe left sided valvular heart disease
- •Most recent documented LVEF ≤30%
- •Women who are pregnant or breastfeeding (women of childbearing potential are required to have negative pregnancy test within 1 week of index procedure)
- •Patients with life expectancy <1 year life as estimated by treating physician.
- •Subjects enrolled in other ongoing non-registry clinical studies that would impact conduct or outcomes of this study (registries and long-term follow-up of other studies are allowed)
- •Subjects who have undergone angiographic or wire-based coronary physiological assessment for 1 or more potential study lesions within 30 days of enrollment.
- •Angiographic Exclusion Criteria:
- •Coronary angiogram is not acquired per instructions as defined in the Study Protocol
- •Sthe study lesion is the clear culprit for a NSTEACS
- •Angiographic evidence of a procedural complication (e.g., acute stent thrombosis, flow-limiting dissection, perforation, slow/no reflow, or other) prior to randomization
- •Thrombolysis in myocardial infarction (TIMI) Grade 2 flow or lower in any study vessel at time of enrollment
- •The study vessel is in a left coronary vessel with separate left anterior descending and left circumflex ostia arising from the aorta
- •The study lesion involves the left main coronary artery (stenosis ≥ 50%)
- •The study lesion is in an ectatic or aneurysmal coronary segment (defined as lumen diameter 1.5x diameter or the reference vessel)
研究组 & 干预措施
FFRangio
Experimental
FFRangio guided revascularization
干预措施: FFRangio (Device)
Pressure wire
Active Comparator
Pressure wire-based guided revascularization (FFR or NHPR)
干预措施: FFR or NHPR (Device)
结局指标
主要结局
MACE
时间窗: 1 year
Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization
次要结局
- Patient Reported Quality of Life - EQ-5D(Baseline, Day 30 and 12 Months)
- Procedure Time(24 hours)
- Stroke(30 Days)
- FFRangio Usability(24 hours)
- All-Cause Mortality(12 months)
- Unplanned Revascularization(12 months)
- Peri-Procedural Complications(30 Days)
- Bleeding(30 Days)
- Patient Reported Health Status - SAQ-7(Baseline, Day 30 and 12 Months)
- Contrast Dose(24 hours)
- Cost-effectiveness(12 Months)
- Myocardial Infarction(12 months)
- Kidney Injury(30 Days)
- Radiation Dose(24 hours)
- Resource utilization(24 hours)
- Stent thrombosis(12 months)
- Pressure Wire Usability(24 hours)
研究者
研究点 (59)
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