OpSens PRIME CLASS

Aortic Stenosis Clinical Trial

Official title:

OpSens dPR for Physiological Assessment of Intermediate Coronary Lesions in Aortic Stenosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05070130
• Other study ID #: PRIME CLASS
• Status: Terminated
• Start date: September 19, 2022
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Opsens, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: April 4, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• dPR and FFR
OpSens non-hyperemic dPR and/or OpSens FFR

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Gregorio Maranon	Madrid
Spain	Hospital Virgen de la Victoria	Malaga
Spain	Hospital Clinico de Santiago	Santiago De Compostela
Spain	Hospital Clinico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Opsens, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Success rate	The success rate of the dPR & FFR procedure, defined as the percentage of cases in which dPR and FFR could be measured, and no procedural complications occurred	Immediately upon completion of the TAVR procedure
Other	Freedom from adenosine administration	The percentage of Subjects who can be spared the administration of adenosine by a hybrid dPR-FFR strategy, while maintaining an overall diagnostic accuracy = 90%	Immediately upon completion of the TAVR procedure
Other	Percentage of concordance and mean difference between pre- and post-TAVR dPR	Percentage of concordance and mean difference between pre- and post-TAVR dPR	Immediately upon completion of the TAVR procedure
Other	Percentage of concordance and mean difference between pre- and post-TAVR FFR	Percentage of concordance and mean difference between pre- and post-TAVR FFR	Immediately upon completion of the TAVR procedure
Primary	Difference between preTAVR dPR specificity and angiography specificity for ischemia	The difference between PreTAVR dPR specificity (%) - angiography specificity (%), taking post-TAVR FFR as the reference measure.	Immediately upon completion of the TAVR procedure
Primary	Diagnostic accuracy	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	Immediately upon completion of the TAVR procedure
Secondary	Difference in accuracy between dPR and angiography	The difference between the percentage of lesions correctly classified by preTAVR dPR and the percentage of lesions correctly classified by angiography, always taking postTAVR FFR as the reference measure.	Immediately upon completion of the TAVR procedure
Secondary	Difference in sensitivity between dPR and angiography	The difference between the sensitivity of preTAVR dPR and the sensitivity of angiography, where: preTAVR sensitivity= preTAVR True positive/ (preTAVR true positive+ preTAVR false negative) * 100; angiography sensitivity= angiography True positive/ (angiography true positive+ angiography false negative) * 100,; taking post-TAVR FFR as the reference measure.	Immediately upon completion of the TAVR procedure
Secondary	Predicting post-TAVR FFR by pre-TAVR FFR	Overall diagnostic accuracy of preTAVR FFR, defined as the percentage of lesions correctly classified by pre-TAVR FFR, taking postTAVR FFR as the reference measure.	Immediately upon completion of the TAVR procedure
Secondary	Difference in accuracy between preTAVR dPR and preTAVR FFR	The difference in the overall diagnostic accuracy of pre-TAVR dPR and pre-TAVR FFR to predict a post-TAVR FFR = 0.80	Immediately upon completion of the TAVR procedure
Secondary	Predicting post-TAVR FFR by pre-TAVR hybrid dPR-FFR	Overall diagnostic accuracyof a pre-TAVR hybrid dPR-FFR based approach to predict a post-TAVR FFR = 0.80	Immediately upon completion of the TAVR procedure