Angiography-derived FFR GPS in Predicting Post-PCI Physiological and Clinical Outcomes
NCT ID: NCT05496023
Last Updated: 2022-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
329 participants
OBSERVATIONAL
2017-01-01
2022-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PrOgnostic Implications of PRe-stent Pullback Pressure GradIent and Post-stent Quantitative Flow Ratio in Patients UnderGoing Percutaneous Coronary INtervention
NCT05104580
RFR and FFR for the the Prediction of Post-PCI Results
NCT04417634
Implication of Coronary Artery Disease Burden and Pattern in Ischemia-causing Vessels With PCI
NCT04665466
Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation
NCT02053038
Routine Versus Selective Use of FFR to Guide PCI
NCT02000661
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Percutaneous coronary intervention
1. 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
Post-PCI state
The post-PCI FFR and angio-FFR will be meaured.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Percutaneous coronary intervention
1. 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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Zhongshan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Junbo Ge, MD
Role: STUDY_CHAIR
Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhongshan Hospital of Fudan University
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Shin 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.
Dai 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHART2022-04
Identifier Type: REGISTRY
Identifier Source: secondary_id
ZS20220808
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.