Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Percentage open grafts of all grafts
研究概览
简要总结
The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary artery bypass grafting (CABG) with respect to planning and guiding the revascularization strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in patients planned for surgical revascularization.
详细描述
FFR measurements are made on all patients that enters the study. FFR measurements on coronary arteries with intermediate stenoses, that are planned for grafting, are done before CABG is performed. Patients are randomized to either an FFR-guided CABG or an Angiography guided CABG.
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
- Double (Participant, Investigator)
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 or unstable angina / NSTEMI (Non ST segment elevation myocardial infarction) candidate to CABG
- •At least one study lesion, which is an intermediate lesion planned for grafting at the Heart Team Meeting.(Definition of Study lesions: ≥ 50% stenosis of a major epicardiel artery (where the proximal reference segment has a diameter> 2.5 mm), which can be passed with a FFR-wire without significant risk. Study Lesions can be drawn from all coronary arteries.)
- •Signed informed consent form
排除标准
- •Significant valvular disease with indication to surgical treatment
- •Previous open-heart-surgery
- •Left main lesion without other intermediate lesions
- •Treatment with Persantin Retard
- •One vessel disease
- •Renal impairment (creatinine ≥ 150 umol / l)
研究组 & 干预措施
Fractional flow reserve-guided CABG
Patients are randomized to an FFR-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan form the heart team meeting are changed by the study investigator according to the FFR-measurements and randomization, so that coronary arteries with FFR ≤ 0,8 receive grafting and coronary arteries with FFR > 0,8 are deferred.
干预措施: Fractional flow reserve-guided CABG (Procedure)
Angiography-guided CABG
Patients are randomized to an angiography-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan are based on the coronary angiography.
干预措施: Angiography-guided CABG (Procedure)
结局指标
主要结局
Percentage open grafts of all grafts
时间窗: 6 months
Open graft definition: graft with TIMI III flow with no anastomosis stenosis (TIMI flow grades based on results of the Thrombolysis In Myocardial Infarction trial)
次要结局
- Change in Quality of life (EQ-5D) from index to FU(6 months)
- Graft stenosis (shaft and anastomoses)(6 months)
- Change in CCS class from index to follow-up (FU)(6 months)
- MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)(6 months)
- Procedural maximum Troponin I (cTnI), Troponin T (TnT) or creatinine kinase MB (CKMB) values depending on local conditions.(The first 24 hours after the operation)
- Procedure time(During surgery (minutes))
研究者
Anne Langhoff Thuesen
MD
Odense University Hospital