Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ceric Sàrl
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- RFRpre vs. RFRfinal
研究概览
简要总结
The use of intra coronary physiological assessment with fractional flow reserve (FFR) is nowadays the standard approach to define ischemia-inducing stenosis and guide myocardial revascularization strategy in patients with coronary artery disease. Further, FFR has been shown to be a strong and independent predictor of major adverse cardiac events after stent implantation. A lower value of FFR after stent implantation is associated with a worse clinical prognosis, without a clearly defined threshold above which clinical follow up are similar for all FFR values. Among 750 patients in the Fractional Flow Reserve Post-Stent Registry, the event rate was 29.5% in patients with FFR<0.80 compared to 9 4.9% in patients with FFR>0.95 (p<0.001). However, FFR remains poorly adopted in many cathlabs, partly because of procedural time, discomfort or sides effect during hyperemia, non-uniform adenosine response and economical constraints. This leads to the validation of resting indices (instantaneous wave-free ratio (iFR), diastolic pressure ratio (dPR), and resting full-cycle ratio (RFR) among others). Those indices evaluate coronary physiology without the use of maximal hyperemia and have 15 slightly different threshold compared to FFR (≤0.89 vs 0.80, for iFR and RFR, and FFR 16 respectively).In the VALIDATE RFR study, a head-to-head comparison of RFR and iFR from a retrospective analysis, diagnostic accuracy of RFR was 97.4% with an area under the curve 1 (AUC) of 99.6%. In the more recent RE-VALIDATE RFR study, 431 patients with 501 lesions 2 were prospectively evaluated for the diagnostic performance of RFR in all-comers patients. Compared to iFR, RFR achieved high diagnostic accuracy, sensitivity and specificity. These are the reasons why we designed a prospective, non-randomized, clinical trial, to better 18 explore the value of RFR before and after PCI in real live and after optimization by post dilation 19 in all-comers patients with coronary artery disease in the Middle East region..
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 21 years
- •The patient is deemed eligible for PCI of at least one coronary stenosis (RFRpre ≤0.89 or FFR≤0.80)
- •The patient is able and is willing to comply with all study procedures and process.
排除标准
- •The patient is in cardiogenic shock
- •The patient has a bifurcation lesion that requires a planned two stents technique
- •The patient refuses to participate.
- •The patient suffers acute coronary syndrome and should be treated by PCI in the culprit lesion (non-culprit lesions in non-culprit vessel could be included)
- •The patient has an ostial stenosis to be treated by PCI
结局指标
主要结局
RFRpre vs. RFRfinal
时间窗: Intra operative, up to 1 month
comparison between RFR (Resting Full Cycle Ratio) before and after optimized PCI (RFRpre vs. RFRfinal) in all included lesions
次要结局
- FFRpre vs. FFRfinal(Intra operative, up to 1 month)
- RFRpre vs. FFRpre: % of lesions(Intra operative, up to 1 month)
- The rate of Major Adverse Coronary Events(Day 1 and Day 30)
- RFRpre vs. RFRpost(Intra operative, up to 1 month)
- RFRpost vs. RFRfinal(Intra operative, up to 1 month)
- FFRpre vs. FFRpost(Intra operative, up to 1 month)
- FFRpost vs. FFRfinal(Intra operative, up to 1 month)
- RFRpost vs. FFRpost/ % of lesions(Intra operative, up to 1 month)
- RFRfinal vs. FFRfinal/ % of lesions(Intra operative, up to 1 month)
- The rate of all cause mortality(Day 1 and Day 30)
- Contrastpost vs. Contrastfinal.(Intra operative, up to 1 month)
- % of patients: RFRpost vs. RFRfinal(Intra operative, up to 1 month)
- The rate of Stent Thrombosis(Day 1 and Day 30)
- Proc Timepost vs. Proc Timefinal.(Intra operative, up to 1 month)
- Irradiationpost vs. Irradiationfinal.(Intra operative, up to 1 month)