Coronary Artery DiseaseAngio-GPSNCT05496023
Angiography-derived FFR GPS in Predicting Post-PCI Physiological and Clinical Outcomes
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
To investigate the feasibility of physiological map generated from angiography-derived fractional flow reserve (FFR) (angio-FFR) pullback and its value in predicting physiological and clinical outcomes after stenting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 329 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Oct 2022
- 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: Patients who diagnosed obstructive coronary artery disease and evaluated by pre-PCI FFR measurement, then treated by DES with invasive physiologic evaluation at the index procedure.
Who may be able to join
- any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
- any patient who underwent PCI for lesions with pre-PCI FFR<=0.80
- available of both pre- and post-PCI FFR measurement
- available of both pre- and post-PCI angio-FFR calculation
- available of pre-PCI co-registration of angio-FFR with coronary angiogram
Who cannot join
- unavailable pre-PCI angio-FFR calculation and co-registration with coronary angiogram
- unavailable post-PCI angio-FFR calculation
- culprit vessel of acute coronary syndrome
- failed achieving TIMI 3 flow at the end of PCI
- left ventricular ejection fraction <30%
- graft vessel
Show all 11Show fewer
- collateral feeder
- in-stent restenosis
- primary myocardial or valvular heart disease
- in patient whose life expectancy less than 2 years
- visible thrombus of target vessel segment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, 200032
Neng Dai, MD, +8613701997266, niceday1987@hotmail.com
Junbo Ge, MD
About this study
Official title: Pre-stenting Angiography-derived Fractional Flow Reserve Pullback Guided PercutaneouS Coronary Intervention Predicts Physiological and Clinical Outcomes in Coronary Artery Disease
To investigate the feasibility of physiological map generated from angiography-derived fractional flow reserve (FFR) (angio-FFR) pullback and its value in predicting physiological and clinical outcomes after stenting.
Read the detailed description
Physiological coronary lesion evaluation such as fractional flow reserve (FFR) is now recommended by guidelines to guide percutaneous coronary intervention (PCI). However, it was not widely used in subsequent years for a variety of reasons, including the additional time needed to measure pressure wire-derived FFR, technical challenges and the small risk associated with maneuvering a pressure wire down a coronary artery, the added time to assess multiple vessels, issues with drift in the pressure wire reading, and the time, expense, and associated side effects with some hyperemic agents necessary to measure FFR.
In recent years, advancements in technology made it possible to calculate FFR from conventional coronary angiography without the need of a pressure wire or hyperemic agent. The FAVOR III (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease) China has demonstrated that angiography-derived FFR (angio-FFR) improved outcomes for PCI compared with a standard angiography-guided strategy.
Like FFR, angio-FFR is also performed in a binary manner to determine whether a vessel requires intervention and does not automatically indicate the haemodynamic improvement that would be expected post stenting. However, one advantage of angio-FFR is that virtual pullback could be generated during its calculation. Most importantly, though hyperemic blood flow was applied in angio-FFR calculation, it was predicted from resting flow with mathematical algorithm. As resting flow is more constant, consistent, and predictable across different stenoses, then resting pressure changes measured along the length of a vessel will be more predictable. Using this property, a physiological vessel map could be produced with angio-FFR by co-registration the pullback onto coronary angiogram, which not only highlight functional significant lesions and lesion locations, but also offer the possibility of prospective simple computerized virtual PCI to assess the potential hemodynamic impact before actual stent implantation.
In this regard, the investigators aim to calculate angio-FFR and to develop an angio-FFR pullback. And the investigators hypothesize that angio-FFR-derived pullback would be possible to produce a physiological map showing lesion severity and location, in addition, it could be used to perform virtual PCI and predict the physiological impact of stenting; the physiological map could be used to measure physiological lesion length and intensity.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionDevice
- Pre-PCI angio-FFR was calculated and virtual pullback was generated
- Automated algorithm to calculate delta angio-FFR per unit length and co-registered onto coronary angiogram was developed
- PCI was performed using 2nd generation DES
| Study group | Role | What they receive |
|---|---|---|
| Pre PCI state | The current study will analyze the angio-FFR and generate the virtual pullback. The pullback will be co-registered by overlaying the pullback onto coronary angiogram. Receives: Device: Percutaneous coronary intervention | |
| Post-PCI state | The post-PCI FFR and angio-FFR will be meaured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propotion of angio-FFR based physiological map successfully created
Propotion of successful angio-FFR based physiological map created by overlaying the angio-FFR based pullback onto coronary angiogram will be calculated
Measured: Immediate after angiography
Correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
Pearson Correlation analysis will be performed to assess the correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
Measured: Immediate post-PCI
Agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
Bland-altman analysis will be performed to assess the agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
Measured: Immediate post-PCI
Secondary outcomes (7)
Correlation of pre-PCI angio-FFR with pre-PCI FFR
Pearson Correlation analysis will be performed to assess the correlation of pre-PCI angio-FFR with pre-PCI FFR
Measured: Immediate after pre-PCI FFR measurement
Agreement of pre-PCI angio-FFR with pre-PCI FFR
Bland-altman analysis will be performed to assess the agreement of pre-PCI angio-FFR with pre-PCI FFR
Measured: Immediate after pre-PCI FFR measurement
Correlation of post-PCI angio-FFR with post-PCI FFR
Pearson Correlation analysis will be performed to assess the correlation of post-PCI angio-FFR with post-PCI FFR
Measured: Immediate post-PCI FFR measurement
Agreement of post-PCI angio-FFR with post-PCI FFR
Bland-altman analysis will be performed to assess the agreement of post-PCI angio-FFR with post-PCI FFR
Measured: Immediate post-PCI FFR measurement
Correlation of pre-PCI angio-FFR derived pullback pressure gradient (PPG) with post-PCI angio-FFR
Pearson Correlation analysis will be performed to assess the correlation of pre-PCI angio-FFR derived pullback pressure gradient with post-PCI angio-FFR
Measured: Immediate post-PCI
Correlation of pre-PCI angio-FFR derived pullback pressure gradient with post-PCI FFR
Pearson Correlation analysis will be performed to assess the correlation of pre-PCI angio-FFR derived pullback pressure gradient with post-PCI FFR
Measured: Immediate post-PCI
Target Vessel Failure
a composite of cardiac death, clinical-driven target vessel-related myocardial infarction, and clinical-driven target vessel revascularization. The target vessel will be defined as the treated vessel with 2nd generation DES which was assessed by post-stenting fractional flow reserve.
Measured: 2 years after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Jan 2017
- Primary completion30 Aug 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, MD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496023
- Sponsor's protocol ID
- ZS20220808
- Other IDs
- CHART2022-04
- Acronym
- Angio-GPS
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dai N, Che W, Liu L, Zhang W, Yin G, Xu B, Xu Y, Duan S, Yu H, Li C, Yao K, Huang D, Ge J. Diagnostic Value of Angiography-Derived IMR for Coronary Microcirculation and Its Prognostic Implication After PCI. Front Cardiovasc Med. 2021 Oct 15;8:735743. doi: 10.3389/fcvm.2021.735743. eCollection 2021.
PubMed 34722667Shin D, Dai N, Lee SH, Choi KH, Lefieux A, Molony D, Hwang D, Kim HK, Jeon KH, Lee HJ, Jang HJ, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Ge J, Lee JM. Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1771-1785. doi: 10.1016/j.jcin.2021.06.013.
PubMed 34412795Dai N, Hwang D, Lee JM, Zhang J, Jeon KH, Paeng JC, Cheon GJ, Koo BK, Ge J. Feasibility of Quantitative Flow Ratio-Derived Pullback Pressure Gradient Index and Its Impact on Diagnostic Performance. JACC Cardiovasc Interv. 2021 Feb 8;14(3):353-355. doi: 10.1016/j.jcin.2020.10.036. No abstract available.
PubMed 33541549
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-stenting Angiography-derived Fractional Flow Reserve Pullback Guided PercutaneouS Coronary Intervention Predicts Physiological and Clinical Outcomes in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05496023
- Acronym / sponsor ID
- Angio-GPS / ZS20220808
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 329 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 10 Aug 2022 (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.
To investigate the feasibility of physiological map generated from angiography-derived fractional flow reserve (FFR) (angio-FFR) pullback and its value in predicting physiological and clinical outcomes after stenting.
Detailed description
Physiological coronary lesion evaluation such as fractional flow reserve (FFR) is now recommended by guidelines to guide percutaneous coronary intervention (PCI). However, it was not widely used in subsequent years for a variety of reasons, including the additional time needed to measure pressure wire-derived FFR, technical challenges and the small risk associated with maneuvering a pressure wire down a coronary artery, the added time to assess multiple vessels, issues with drift in the pressure wire reading, and the time, expense, and associated side effects with some hyperemic agents necessary to measure FFR.
In recent years, advancements in technology made it possible to calculate FFR from conventional coronary angiography without the need of a pressure wire or hyperemic agent. The FAVOR III (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease) China has demonstrated that angiography-derived FFR (angio-FFR) improved outcomes for PCI compared with a standard angiography-guided strategy.
Like FFR, angio-FFR is also performed in a binary manner to determine whether a vessel requires intervention and does not automatically indicate the haemodynamic improvement that would be expected post stenting. However, one advantage of angio-FFR is that virtual pullback could be generated during its calculation. Most importantly, though hyperemic blood flow was applied in angio-FFR calculation, it was predicted from resting flow with mathematical algorithm. As resting flow is more constant, consistent, and predictable across different stenoses, then resting pressure changes measured along the length of a vessel will be more predictable. Using this property, a physiological vessel map could be produced with angio-FFR by co-registration the pullback onto coronary angiogram, which not only highlight functional significant lesions and lesion locations, but also offer the possibility of prospective simple computerized virtual PCI to assess the potential hemodynamic impact before actual stent implantation.
In this regard, the investigators aim to calculate angio-FFR and to develop an angio-FFR pullback. And the investigators hypothesize that angio-FFR-derived pullback would be possible to produce a physiological map showing lesion severity and location, in addition, it could be used to perform virtual PCI and predict the physiological impact of stenting; the physiological map could be used to measure physiological lesion length and intensity.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre PCI state | – | Device: Percutaneous coronary interventionThe current study will analyze the angio-FFR and generate the virtual pullback. The pullback will be co-registered by overlaying the pullback onto coronary angiogram. |
| Post-PCI state | – | –The post-PCI FFR and angio-FFR will be meaured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed obstructive coronary artery disease and evaluated by pre-PCI FFR measurement, then treated by DES with invasive physiologic evaluation at the index procedure.
Key inclusion criteria (5 listed)
- any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
- any patient who underwent PCI for lesions with pre-PCI FFR<=0.80
- available of both pre- and post-PCI FFR measurement
- available of both pre- and post-PCI angio-FFR calculation
- available of pre-PCI co-registration of angio-FFR with coronary angiogram
Key exclusion criteria (11 listed)
- unavailable pre-PCI angio-FFR calculation and co-registration with coronary angiogram
- unavailable post-PCI angio-FFR calculation
- culprit vessel of acute coronary syndrome
- failed achieving TIMI 3 flow at the end of PCI
- left ventricular ejection fraction <30%
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 |
|---|---|---|
| Percutaneous coronary intervention1. Pre-PCI angio-FFR was calculated and virtual pullback was generated 2. Automated algorithm to calculate delta angio-FFR per unit length and co-registered onto coronary angiogram was developed 3. PCI was performed using 2nd generation DES | Device | Pre PCI state |
Primary outcome
Propotion of angio-FFR based physiological map successfully created
Time frame: Immediate after angiography
Propotion of successful angio-FFR based physiological map created by overlaying the angio-FFR based pullback onto coronary angiogram will be calculated
Correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
Time frame: Immediate post-PCI
Pearson Correlation analysis will be performed to assess the correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
Agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
Time frame: Immediate post-PCI
Bland-altman analysis will be performed to assess the agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI
7 secondary outcomes
Correlation of pre-PCI angio-FFR with pre-PCI FFR
Time frame: Immediate after pre-PCI FFR measurement
Agreement of pre-PCI angio-FFR with pre-PCI FFR
Time frame: Immediate after pre-PCI FFR measurement
Correlation of post-PCI angio-FFR with post-PCI FFR
Time frame: Immediate post-PCI FFR measurement
Agreement of post-PCI angio-FFR with post-PCI FFR
Time frame: Immediate post-PCI FFR measurement
Correlation of pre-PCI angio-FFR derived pullback pressure gradient (PPG) with post-PCI angio-FFR
Time frame: Immediate post-PCI
Correlation of pre-PCI angio-FFR derived pullback pressure gradient with post-PCI FFR
Time frame: Immediate post-PCI
Target Vessel Failure
Time frame: 2 years after index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Background: PubMed 34722667Dai N, Che W, Liu L, Zhang W, Yin G, Xu B, Xu Y, Duan S, Yu H, Li C, Yao K, Huang D, Ge J. Diagnostic Value of Angiography-Derived IMR for Coronary Microcirculation and Its Prognostic Implication After PCI. Front Cardiovasc Med. 2021 Oct 15;8:735743. doi: 10.3389/fcvm.2021.735743. eCollection 2021.
- Background: PubMed 34412795Shin D, Dai N, Lee SH, Choi KH, Lefieux A, Molony D, Hwang D, Kim HK, Jeon KH, Lee HJ, Jang HJ, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Ge J, Lee JM. Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1771-1785. doi: 10.1016/j.jcin.2021.06.013.
- Background: PubMed 33541549Dai N, Hwang D, Lee JM, Zhang J, Jeon KH, Paeng JC, Cheon GJ, Koo BK, Ge J. Feasibility of Quantitative Flow Ratio-Derived Pullback Pressure Gradient Index and Its Impact on Diagnostic Performance. JACC Cardiovasc Interv. 2021 Feb 8;14(3):353-355. doi: 10.1016/j.jcin.2020.10.036. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Junbo Ge, MD study chair
Fudan University
1 site 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, run by Shanghai Zhongshan Hospital at 1 site 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neng Dai, MD (+8613701997266, niceday1987@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propotion of angio-FFR based physiological map successfully created (time frame: Immediate after angiography). The study lists 3 primary outcomes in all. 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 NCT05496023, which also lists 3 linked publications.
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 10 Aug 2022.