OpSens PRIME CLASS

NCT ID: NCT05070130

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2023-04-04

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.

Conditions

Aortic Stenosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

dPR and FFR

Subjects with aortic stenosis who are considered for TAVR will undergo a physiological assessment and prediction of ischemic coronary lesions pre- and post-TAVR by using Opsens non-hyperemic dPR and/or Opsens FFR

dPR and FFR

Intervention Type: DEVICE

OpSens non-hyperemic dPR and/or OpSens FFR

Interventions

dPR and FFR

OpSens non-hyperemic dPR and/or OpSens FFR

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Opsens, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrique Gutierrez Ibanes, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Gregoio Maranon

Locations

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Hospital Gregorio Maranon

Madrid, , Spain

Hospital Virgen de la Victoria

Málaga, , Spain

Hospital Clinico de Santiago

Santiago de Compostela, , Spain

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Countries

Spain

Other Identifiers

PRIME CLASS

Identifier Type: -

Identifier Source: org_study_id