Coronary Artery DiseaseSUPREMENCT03541577
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement
An observational study of Coronary Artery Disease and Coronary Disease, run by Insight Lifetech Co., Ltd. at 4 sites in China.
Trial summary
TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM Microcatheter below) is a novel device for evaluating the functional significance of coronary stenosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
- What is being tested?
- TruePhysioTM Microcatheter and Pressure Wire
- Type of treatment
- Medical device
- How many people
- 242 participants
- Where
- 4 sitesChina
- Study dates
- 19 Jun 2018to 31 Jan 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease for whom FFR measurement is thought to be clinically indicated.
Who may be able to join
None listed.
Who cannot join
- General Exclusion Criteria:
- Acute ST-elevation or non-ST-elevation myocardial infarction
- Severe heart failure (NYHA≥IV)
- Left ventricular ejection fraction <30%
- Allergy to adenosine triphosphate (ATP)
- Contraindications for percutaneous coronary intervention (PCI)
Show all 10Show fewer
- Angiographic Exclusion Criteria:
- Target vessel has angiographically visible or suspected thrombus
- Angiographic evidence of a dissection
- Excessive tortuosity or calcification stenosis, left main stenosis, serial stenosis
Trial locations and contacts
4 sites in 1 country.
China4 sites
Guangdong General Hospital
Guangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Shanghai Zhongshan Hospital
Shanghai
Shenzhen People's Hospital
Shenzhen
About this study
Official title: Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement: A Multi-center Prospective Control Study
TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM Microcatheter below) is a novel device for evaluating the functional significance of coronary stenosis. This study will compare the differences, if any, between the coronary fractional flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.
Read the detailed description
Many studies have reported that FFR-guided coronary revascularization leads to improved long-term clinical outcomes and reduced costs compared with angiography-guided coronary revascularization alone. Current guidelines emphasize the measurement of FFR as the standard of reference when determining the functional significance of coronary artery stenosis in stable patients when evidence of ischemia is not available (class IA indication). But FFR is still underutilized in clinical practice. One of the reasons may be the difficulty in manipulating the Pressure Wire.
TruePhysioTM Microcatheter is a novel device for evaluating the functional significance of coronary stenosis, which may simplify FFR measurements by allowing the use of standard guidewires best suited to negotiating the patients' anatomy. This study is a prospective, open label, multi-center study with the purpose of comparing the differences, if any, between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. The secondary purpose is to analyze the correlation between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. A total of 239 patients will be recruited at 4 centers in China.
- Being tested
- TruePhysioTM Microcatheter, Pressure Wire
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruePhysioTM MicrocatheterDevice
Also called FFR Microcatheter
Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).
Pressure WireDevice
Also called PressureWire
Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).
| Study group | Role | What they receive |
|---|---|---|
| Participants | Subjects who meet the inclusion criteria and do not meet the exclusion criteria and undergo FFR measurement with the TruePhysioTM Microcatheter and the Pressure Wire Receives: Device: TruePhysioTM Microcatheter; Device: Pressure Wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFR Measurements
Comparisons between the FFR measured by the TruePhysioTM Microcatheter and the Pressure Wire (PW), including bias, as assessed by Bland-Altman analysis.
Measured: Duration of FFR measurement
Secondary outcomes (10)
Pearson analysis
Pearson analysis of paired FFR measurements by TruePhysioTM Microcatheter and PW.
Measured: Duration of FFR measurement
Slope of Passing-Bablok fit
Slope of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.
Measured: Duration of FFR measurement
Intercept of Passing-Bablok fit
Intercept of Passing-Bablok fit between paired FFR measurements by TruePhysioTM Microcatheter and PW.
Measured: Duration of FFR measurement
Diagnostic FFR concurrence of functionally significant stenosis
Concurrence of TruePhysioTM Microcatheter FFR diagnostic accuracy of functionally significant stenosis, using PW FFR ≤0.80 as the reference.
Measured: Duration of FFR measurement
Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis
Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis at the vessel level with PW FFR as the reference standard (PW FFR ≤0.80 as positive case).
Measured: Duration of FFR measurement
Device success rate
Device success rate, defined as a valid FFR reading for each system, and comparison between the two systems.
Measured: Duration of FFR measurement
Mean drift
Mean drift, defined as the absolute difference between Pd/Pa at the equalization position after pullback and 1.00, for each system, and comparison between the two systems.
Measured: Duration of FFR measurement
Rate of clinically significant drift
Rate of clinically significant drift (drift >0.03), for each system, and comparison between the two systems.
Measured: Duration of FFR measurement
Rate of device-related adverse effects
Rate of device-related adverse effects, for each system individually, and comparison between the two systems.
Measured: Duration of FFR Procedure
PW FFR measurements with TruePhysioTM Microcatheter across and not across lesion
Comparisons between PW FFR measurements with TruePhysioTM Microcatheter across lesion and with TruePhysioTM Microcatheter not across lesion, including bias, as assessed by Bland-Altman analysis.
Measured: Duration of FFR Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start19 Jun 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insight Lifetech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Guangdong Provincial People's Hospital, Shenzhen People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541577
- Sponsor's protocol ID
- CTP17-001
- Acronym
- SUPREME
- Status last verified
- May 2022
- First submitted
- 17 May 2018
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li C, Yang J, Dong S, Dong L, Chen J, Shen L, Zhang F, Li C, Liu H, Hu X, Hau WK, Qian J, Jeremias A, Wang J, Ge J; SUPREME Study Investigators. Multicenter clinical evaluation of a piezoresistive-MEMS-sensor rapid-exchange pressure microcatheter system for fractional flow reserve measurement. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E243-E253. doi: 10.1002/ccd.29678. Epub 2021 May 5.
PubMed 33951285
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement: A Multi-center Prospective Control Study
- ClinicalTrials.gov ID
- NCT03541577
- Acronym / sponsor ID
- SUPREME / CTP17-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Insight Lifetech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Guangdong Provincial People's Hospital, Shenzhen People's Hospital
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 30 May 2018 (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.
TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM Microcatheter below) is a novel device for evaluating the functional significance of coronary stenosis. This study will compare the differences, if any, between the coronary fractional flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.
Detailed description
Many studies have reported that FFR-guided coronary revascularization leads to improved long-term clinical outcomes and reduced costs compared with angiography-guided coronary revascularization alone. Current guidelines emphasize the measurement of FFR as the standard of reference when determining the functional significance of coronary artery stenosis in stable patients when evidence of ischemia is not available (class IA indication). But FFR is still underutilized in clinical practice. One of the reasons may be the difficulty in manipulating the Pressure Wire.
TruePhysioTM Microcatheter is a novel device for evaluating the functional significance of coronary stenosis, which may simplify FFR measurements by allowing the use of standard guidewires best suited to negotiating the patients' anatomy. This study is a prospective, open label, multi-center study with the purpose of comparing the differences, if any, between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. The secondary purpose is to analyze the correlation between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. A total of 239 patients will be recruited at 4 centers in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: TruePhysioTM Microcatheter, Device: Pressure WireSubjects who meet the inclusion criteria and do not meet the exclusion criteria and undergo FFR measurement with the TruePhysioTM Microcatheter and the Pressure Wire |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease for whom FFR measurement is thought to be clinically indicated.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Acute ST-elevation or non-ST-elevation myocardial infarction
- Severe heart failure (NYHA≥IV)
- Left ventricular ejection fraction <30%
- Allergy to adenosine triphosphate (ATP)
- Contraindications for percutaneous coronary intervention (PCI)
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 |
|---|---|---|
| TruePhysioTM MicrocatheterAlso: FFR MicrocatheterProvide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR). | Device | Participants |
| Pressure WireAlso: PressureWireProvide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR). | Device | Participants |
Primary outcome
FFR Measurements
Time frame: Duration of FFR measurement
Comparisons between the FFR measured by the TruePhysioTM Microcatheter and the Pressure Wire (PW), including bias, as assessed by Bland-Altman analysis.
10 secondary outcomes
Pearson analysis
Time frame: Duration of FFR measurement
Slope of Passing-Bablok fit
Time frame: Duration of FFR measurement
Intercept of Passing-Bablok fit
Time frame: Duration of FFR measurement
Diagnostic FFR concurrence of functionally significant stenosis
Time frame: Duration of FFR measurement
Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis
Time frame: Duration of FFR measurement
Device success rate
Time frame: Duration of FFR measurement
Mean drift
Time frame: Duration of FFR measurement
Rate of clinically significant drift
Time frame: Duration of FFR measurement
Rate of device-related adverse effects
Time frame: Duration of FFR Procedure
PW FFR measurements with TruePhysioTM Microcatheter across and not across lesion
Time frame: Duration of FFR Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Results publication: PubMed 33951285Li C, Yang J, Dong S, Dong L, Chen J, Shen L, Zhang F, Li C, Liu H, Hu X, Hau WK, Qian J, Jeremias A, Wang J, Ge J; SUPREME Study Investigators. Multicenter clinical evaluation of a piezoresistive-MEMS-sensor rapid-exchange pressure microcatheter system for fractional flow reserve measurement. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E243-E253. doi: 10.1002/ccd.29678. Epub 2021 May 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Disease, run by Insight Lifetech Co., Ltd. at 4 sites in China.
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 0 inclusion and 10 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: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FFR Measurements (time frame: Duration of FFR measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03541577, which also lists 1 linked publication.
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 May 2022.