OpSens dPR for Physiological Assessment of Intermediate Coronary Lesions in Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Opsens, Inc.
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Difference between preTAVR dPR specificity and angiography specificity for ischemia
研究概览
简要总结
In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment. Post-TAVR FFR will be taken as the reference for predicting ischemic lesions, and angiography and physiology - FFR and diastolic pressure ratio (dPR) - will be performed immediately before and after TAVR, in an all-comer multicentric observational study.
详细描述
This is a post-marketing, prospective, observational, single arm, multi-center, single country study in Subjects who have severe symptomatic aortic stenosis with a formal indication for TAVR, and one or more intermediate coronary lesions in a relevant coronary artery (>2mm). This study aims to assess if OpSens non-hyperemic dPR (based on a proprietary algorithm) and/or OpSens FFR are suitable methods for the physiological assessment and prediction of ischemic coronary lesions in Subjects with aortic stenosis who are considered for TAVR. This will be done by comparing pre-TAVR measurements of angiography, dPR and FFR and placing them against the post-TAVR FFR, which is considered as the gold standard. Also the post TAVR dPR will be compared with post-TAVR FFR.
A maximum of 137 subjects will be enrolled in 5 to 10 sites in Spain to obtain the required minimum of 137 lesions (see section 11.2 Sample Size Determination) The main hypothesis is that the specificity to predict ischemic lesions in TAVR candidates based on a pre-TAVR dPR ≤ 0.89 is superior compared to the specificity based on angiography alone (both QCA and visual assessment of the stenosis >50%), taking the post-TAVR FFR value of ≤ 0.80 as a reference for positive lesions.
The pressure guidewire used to measure dPR and FFR during diagnostic angiography is the commercially available (CE-marketed) OptoWire family of pressure guidewires from OpSens Inc.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is at least 18 years old
- •Subject has a degenerative aortic stenosis with mean valvular gradient ≥40 mmHg
- •Subject has a formal heart-team indication for TAVR
- •Subject has one or more stable coronary stenosis lesions 30-90% by visual estimation, in a vessel over 2 mm in diameter, and which is amenable for pressure-wire analysis
- •Subject agrees to participate in the study and is able to sign the informed consent form
排除标准
- •Subject is unable to provide informed consent
- •Subject has asthma or acute bronchospasm
- •Subject has unstable angina or myocardial infarction
- •Subject meets any contraindication in the applicable OptoWire IFU
- •Subject is pregnant
结局指标
主要结局
Difference between preTAVR dPR specificity and angiography specificity for ischemia
时间窗: Immediately upon completion of the TAVR procedure
The difference between PreTAVR dPR specificity (%) - angiography specificity (%), taking post-TAVR FFR as the reference measure.
Diagnostic accuracy
时间窗: Immediately upon completion of the TAVR procedure
Establish sufficiently precise estimates (+/- 6.5% around estimate) for the diagnostic accuracy of pre-TAVR dPR expressed in terms of sensitivity and specificity, taking as the reference for ischemia the post-TAVR FFR
次要结局
- Difference in sensitivity between dPR and angiography(Immediately upon completion of the TAVR procedure)
- Difference in accuracy between dPR and angiography(Immediately upon completion of the TAVR procedure)
- Predicting post-TAVR FFR by pre-TAVR hybrid dPR-FFR(Immediately upon completion of the TAVR procedure)
- Difference in accuracy between preTAVR dPR and preTAVR FFR(Immediately upon completion of the TAVR procedure)
- Predicting post-TAVR FFR by pre-TAVR FFR(Immediately upon completion of the TAVR procedure)