Clinical trial NCT05070130: OpSens PRIME CLASS
Official title: OpSens dPR for Physiological Assessment of Intermediate Coronary Lesions in Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Stenosis
Keywords: Fractional flow reserve
Diastolic pressure ratio
Transcatheter aortic valve replacement
Lead sponsor: Opsens, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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) are considered for this study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference between preTAVR dPR specificity and angiography specificity for ischemia
timeFrame: Immediately upon completion of the TAVR procedure
measure: Diagnostic accuracy
timeFrame: Immediately upon completion of the TAVR procedure
Secondary outcomes:
measure: Difference in accuracy between dPR and angiography
timeFrame: Immediately upon completion of the TAVR procedure
measure: Difference in sensitivity between dPR and angiography
timeFrame: Immediately upon completion of the TAVR procedure
measure: Predicting post-TAVR FFR by pre-TAVR FFR
timeFrame: Immediately upon completion of the TAVR procedure
measure: Difference in accuracy between preTAVR dPR and preTAVR FFR
timeFrame: Immediately upon completion of the TAVR procedure
measure: Predicting post-TAVR FFR by pre-TAVR hybrid dPR-FFR
timeFrame: Immediately upon completion of the TAVR procedure
Other outcomes:
measure: Success rate
timeFrame: Immediately upon completion of the TAVR procedure
measure: Freedom from adenosine administration
timeFrame: Immediately upon completion of the TAVR procedure
measure: Percentage of concordance and mean difference between pre- and post-TAVR dPR
timeFrame: Immediately upon completion of the TAVR procedure
measure: Percentage of concordance and mean difference between pre- and post-TAVR FFR
timeFrame: Immediately upon completion of the TAVR procedure
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico de Santiago
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
affiliation: Hospital Gregoio Maranon
name: Enrique Gutierrez Ibanes, MD
role: PRINCIPAL_INVESTIGATOR
References: