Aortic StenosisNCT05070130
OpSens PRIME CLASS
An observational study of Aortic Stenosis, run by Opsens, Inc. at 5 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- dPR and FFR
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 5 sitesSpain
- Study dates
- 19 Sep 2022to 4 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Hospital Gregorio Maranon
Madrid, 28007
Hospital Virgen de la Victoria
Málaga, 29110
Hospital Clinico de Santiago
Santiago de Compostela, 15706
Hospital Clinico Universitario de Valladolid
Valladolid, 47011
About this study
Official title: OpSens dPR for Physiological Assessment of Intermediate Coronary Lesions in Aortic Stenosis
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.
Read the 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
- Being tested
- dPR and FFR
- Keywords
- Fractional flow reserve, Diastolic pressure ratio, Transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dPR and FFRDevice
OpSens non-hyperemic dPR and/or OpSens FFR
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: dPR and FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately upon completion of the TAVR procedure
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
Measured: Immediately upon completion of the TAVR procedure
Secondary outcomes (5)
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.
Measured: Immediately upon completion of the TAVR procedure
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.
Measured: Immediately upon completion of the TAVR procedure
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.
Measured: Immediately upon completion of the TAVR procedure
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
Measured: Immediately upon completion of the TAVR procedure
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
Measured: Immediately upon completion of the TAVR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start19 Sep 2022
- Primary completion15 Mar 2023
- Study completion4 Apr 2023
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opsens, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrique Gutierrez Ibanes, MD, Principal investigator, Hospital Gregoio Maranon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070130
- Sponsor's protocol ID
- PRIME CLASS
- Status last verified
- Apr 2023
- First submitted
- 2 Sep 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OpSens dPR for Physiological Assessment of Intermediate Coronary Lesions in Aortic Stenosis
- ClinicalTrials.gov ID
- NCT05070130
- Acronym / sponsor ID
- PRIME CLASS
- Conditions
- Aortic Stenosis
- Keywords
- Fractional flow reserve, Diastolic pressure ratio, Transcatheter aortic valve replacement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Opsens, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dPR and FFR | – | Device: dPR and FFRSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dPR and FFROpSens non-hyperemic dPR and/or OpSens FFR | Device | dPR and FFR |
Primary outcome
Difference between preTAVR dPR specificity and angiography specificity for ischemia
Time frame: 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
Time frame: 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
5 secondary outcomes
Difference in accuracy between dPR and angiography
Time frame: Immediately upon completion of the TAVR procedure
Difference in sensitivity between dPR and angiography
Time frame: Immediately upon completion of the TAVR procedure
Predicting post-TAVR FFR by pre-TAVR FFR
Time frame: Immediately upon completion of the TAVR procedure
Difference in accuracy between preTAVR dPR and preTAVR FFR
Time frame: Immediately upon completion of the TAVR procedure
Predicting post-TAVR FFR by pre-TAVR hybrid dPR-FFR
Time frame: Immediately upon completion of the TAVR procedure
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Gutierrez Ibanes, MD principal investigator
Hospital Gregoio Maranon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Opsens, Inc. at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between preTAVR dPR specificity and angiography specificity for ischemia (time frame: Immediately upon completion of the TAVR procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.