Percutaneous Coronary InterventionCT-COMPASSNCT06280638
CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS)
A study testing Virtual stent-guided incremental optimization strategy (VIOS) and Standard angiographic strategy in people with Percutaneous Coronary Intervention and Coronary Physiology, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Coronary Physiology, Computed Tomography
- What is being tested?
- Virtual stent-guided incremental optimization strategy (VIOS) and Standard angiographic strategy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2024to 20 Jul 2025
- Phase
- Interventional
- 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
Who may be able to join
- General Inclusion Criteria
- Age ≥ 18 years.
- Able to understand the trial design and provide written informed consent.
- Patients with a coronary CTA performed within 30 days.
- CCTA Inclusion Criteria
- The CCTA angiograms amenable to CT-FFR measurement.
Show all 10Show fewer
- At least 1 lesion of 50%-90% diameter stenosis in a coronary artery with ≥2.0mm reference vessel diameter by visual assessment.
- And this target vessel is of physiological ischemia as assessed by CT-FFR.
- Angiographic Inclusion Criteria
- 1. The interrogated vessel is indicated for intervention assessed by operator based on indications other than CT-FFR.
Who cannot join
- General Exclusion Criteria
- Cardiogenic shock or severe heart failure (NYHA ≥III or LVEF<30%).
- Severely impaired renal function: creatinine >150μmol/L or Cockcroft-Gault calculated GFR <45 ml/kg/1.73 m2 (calculated with Cockcroft-Gault formula).
- Allergy to iodine-containing contrast agents which cannot be adequately premedicated.
- CCTA Exclusion Criteria
- The CCTA angiograms deems not amenable to CT-FFR measurement.
Show all 13Show fewer
- Patients with only 1 coronary artery lesion with DS >90% with TIMI flow <3.
- An interrogated vessel presented with a CTO lesion.
- All coronary arteries were not physiologically ischemic.
- Coronary lesions favor CABG treatment.
- Angiographic Exclusion Criteria
- The interrogated vessel with only 1 coronary artery lesion with DS >90% with TIMI flow <3.
- Coronary lesions favor CABG treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
About this study
Official title: Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients With Coronary Artery Disease
A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique.
Computed tomography (CT) coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.
However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90).
Read the detailed description
Coronary physiology-guided percutaneous coronary intervention (PCI) improves long-term prognosis in large clinical studies, and wire-based physiological assessments (e.g. fractional flow reserve [FFR], instantaneous wave-free ratio [iFR]) are recommended by international guidelines. Although prognosis of patients undergoing PCI has improved in recent decades with the continuous refinement of equipment, tools and techniques, a considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina or adverse events after angiographically successful PCI. Therefore, it is of great clinical importance to achieve complete resolution of ischemia and optimal functional results during the index procedure.
Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique. The resent TARGET-FFR trial demonstrated that post-PCI physiology-guided incremental optimization strategy (PIOS) failed to significantly improve the final physiological results compared to standard angiographic guidance. Therefore, it would be of significant interest if a preprocedural measurement would be able to anticipate to what extent the functional ischemia could be resolved. If residual ischemia estimated from the computation of post-PCI physiology appears to be present, this would help physicians to develop the best strategies while planning the procedure.
The Computed tomography (CT)-derived FFR (CT-FFR) is a novel non-invasive CCTA-based physiological index that has been validated to have good diagnostic accuracy in identifying physiologically significant coronary stenoses compared with FFR as the reference. The CT coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms, is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.
However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90).
Virtual stenting-guided incremental optimization strategy (VIOS) Protocol: virtual Stenting analysis is conducted based on pre-PCI CCTA angiograms by "Imaging-Heart Team" to determine simulated optimal treatment strategy according VIOS protocol. The details of VIOS protocol are as follows: 1) virtual stent with adequate stent parameters is initially implanted to treat lesion with maximal CT-FFR drop (ΔCT-FFR); 2) if the simulated post-PCI CT-FFR is ≥0.90, no further intervention will be performed, and the simulated optimal treatment strategy is determined. If simulated post-PCI CT-FFR is <0.90, the "Imaging-Heart Team" would then have the following options: a) if there is a CT-FFR drop ≥0.05 across the virtual stented segment(s), the parameters of virtual stent(s) would be optimized (i.e., number of stents, stent diameter, and stent length); b) if there is a CT-FFR drop ≥0.05 across a relatively focal (<20mm) unstented segment (without virtual stenting) which is suitable for further stenting then a further virtual stent would be implanted; c) simulated post-PCI CT-FFR remains <0.90 after steps a and/or b: if either of the above criteria remain, option of further optimization of virtual stent parameters or one more additional virtual stent. Following this, the result will be accepted. d) if the simulated CT-FFR gradient is interpreted to reflect diffuse atherosclerosis with no focal CT-FFR drop, the result is accepted.
- Being tested
- Virtual stent-guided incremental optimization strategy (VIOS), Standard angiographic strategy
- Keywords
- Percutaneous Coronary Intervention, Coronary Physiology, Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual stent-guided incremental optimization strategy (VIOS)Other
Also called VIOS-based PCI
PCI is performed according to strategy recommended by "Imaging-Heart Team" based on VIOS protocol.
Standard angiographic strategyOther
Also called angio-based PCI
PCI is performed based on international guidelines, local protocols and practice.
| Study group | Role | What they receive |
|---|---|---|
| Virtual stenting-guided incremental optimization strategy (VIOS) | Experimental | Virtual Stenting analysis is conducted based on pre-PCI CCTA angiograms by "Imaging-Heart Team" to determine simulated optimal treatment strategy according VIOS protocol. If the patient is assigned to the VIOS, the result of virtual stenting and recommended treatment strategy will be disclosed to the operator. The operator will then follow the recommended strategy to attempt to obtain the target optimal post-PCI FFR result. Blinded FFR must be obtained after PCI. Receives: Other: Virtual stent-guided incremental optimization strategy (VIOS) |
| Standard angiographic strategy | Sham comparator | Virtual Stenting analysis is conducted based on pre-PCI CCTA angiograms by "Imaging-Heart Team" to determine simulated optimal treatment strategy according VIOS protocol. If the patient is assigned to the standard angiographic strategy, the result of virtual stenting and recommended treatment strategy will be blinded to the operator. The operator will then perform PCI based on international guidelines, local protocols and practice. Blinded FFR must be obtained after PCI. Receives: Other: Standard angiographic strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a final post-PCI FFR result ≥0.90
The proportion of patients with a final post-PCI FFR result ≥0.90 will be compared between the randomised groups
Measured: 1 days
Secondary outcomes (10)
The proportion of patients with final post-PCI FFR ≤0.80
The proportion of patients with a final post-PCI FFR result ≤0.80 will be compared between the randomised groups
Measured: 1 days
The rate of target vessel failure (TVF) and its component features at 6 months.
Component features of TVF include cardiac death, target vessel myocardial infarction, and target vessel revascularisation.
Measured: 6 months
The rate of target vessel failure (TVF) and its component features at 1 year.
Component features of TVF include cardiac death, target vessel myocardial infarction, and target vessel revascularisation.
Measured: 1 year
Change from baseline in self-reported Health-related quality of life evaluation at 6 months.
Patients will complete the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline pre-procedure and again at 6 months post PCI
Measured: 6 months
Change from baseline in self-reported Health-related quality of life evaluation at 1 year.
Patients will complete the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline pre-procedure and again at 1 year post PCI
Measured: 1 year
Change from baseline in self-reported Angina status evaluation at 6 months.
Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 6 months post PCI
Measured: 6 months
Change from baseline in self-reported Angina status evaluation at 1 year.
Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 1 year post PCI
Measured: 1 year
Procedure Duration
The time required to perform the VIOS intervention procedures will be compared with those in the control group.
Measured: 1 day
Fluoroscopy Dose
The radiation doses for the VIOS intervention procedures will be compared with those in the control group.
Measured: 1 day
Contrast Material Dose
The contrast material doses for the VIOS intervention procedures will be compared with those in the control group.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start5 Mar 2024
- Primary completion23 Jun 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kefei Dou, MD, China National Center for Cardiovascular Diseases
- Investigators
- Kefei Dou, MD, PhD, Principal investigator, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280638
- Sponsor's protocol ID
- 2023-2095
- Acronym
- CT-COMPASS
- Status last verified
- Aug 2025
- First submitted
- 11 Feb 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sonck J, Nagumo S, Norgaard BL, Otake H, Ko B, Zhang J, Mizukami T, Maeng M, Andreini D, Takahashi Y, Jensen JM, Ihdayhid A, Heggermont W, Barbato E, Mileva N, Munhoz D, Bartunek J, Updegrove A, Collinsworth A, Penicka M, Van Hoe L, Leipsic J, Koo BK, De Bruyne B, Collet C. Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography. JACC Cardiovasc Imaging. 2022 Jul;15(7):1242-1255. doi: 10.1016/j.jcmg.2022.02.003. Epub 2022 Apr 13.
PubMed 35798401Biscaglia S, Verardi FM, Tebaldi M, Guiducci V, Caglioni S, Campana R, Scala A, Marrone A, Pompei G, Marchini F, Scancarello D, Pignatelli G, D'Amore SM, Colaiori I, Demola P, Di Serafino L, Tumscitz C, Penzo C, Erriquez A, Manfrini M, Campo G. QFR-Based Virtual PCI or Conventional Angiography to Guide PCI: The AQVA Trial. JACC Cardiovasc Interv. 2023 Apr 10;16(7):783-794. doi: 10.1016/j.jcin.2022.10.054. Epub 2023 Mar 8.
PubMed 36898939Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.
PubMed 34279606Zhang R, Xu B, Dou K, Guan C, Zhao Y, Wang X, Zou T, Qiao Z, Xie L, Wang H, Yuan S, Song L, Tu S, Wang Y, Wijns W. Post-PCI outcomes predicted by pre-intervention simulation of residual quantitative flow ratio using augmented reality. Int J Cardiol. 2022 Apr 1;352:33-39. doi: 10.1016/j.ijcard.2022.01.054. Epub 2022 Jan 31.
PubMed 35101540Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.
PubMed 34742368Ding D, Huang J, Westra J, Cohen DJ, Chen Y, Andersen BK, Holm NR, Xu B, Tu S, Wijns W. Immediate post-procedural functional assessment of percutaneous coronary intervention: current evidence and future directions. Eur Heart J. 2021 Jul 15;42(27):2695-2707. doi: 10.1093/eurheartj/ehab186.
PubMed 33822922Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
PubMed 30165437
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06280638
- Acronym / sponsor ID
- CT-COMPASS / 2023-2095
- Keywords
- Percutaneous Coronary Intervention, Coronary Physiology, Computed Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 28 Feb 2024 (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.
A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique.
Computed tomography (CT) coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.
However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90).
Detailed description
Coronary physiology-guided percutaneous coronary intervention (PCI) improves long-term prognosis in large clinical studies, and wire-based physiological assessments (e.g. fractional flow reserve [FFR], instantaneous wave-free ratio [iFR]) are recommended by international guidelines. Although prognosis of patients undergoing PCI has improved in recent decades with the continuous refinement of equipment, tools and techniques, a considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina or adverse events after angiographically successful PCI. Therefore, it is of great clinical importance to achieve complete resolution of ischemia and optimal functional results during the index procedure.
Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique. The resent TARGET-FFR trial demonstrated that post-PCI physiology-guided incremental optimization strategy (PIOS) failed to significantly improve the final physiological results compared to standard angiographic guidance. Therefore, it would be of significant interest if a preprocedural measurement would be able to anticipate to what extent the functional ischemia could be resolved. If residual ischemia estimated from the computation of post-PCI physiology appears to be present, this would help physicians to develop the best strategies while planning the procedure.
The Computed tomography (CT)-derived FFR (CT-FFR) is a novel non-invasive CCTA-based physiological index that has been validated to have good diagnostic accuracy in identifying physiologically significant coronary stenoses compared with FFR as the reference. The CT coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms, is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.
However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90).
Virtual stenting-guided incremental optimization strategy (VIOS) Protocol: virtual Stenting analysis is conducted based on pre-PCI CCTA angiograms by "Imaging-Heart Team" to determine simulated optimal treatment strategy according VIOS protocol. The details of VIOS protocol are as follows: 1) virtual stent with adequate stent parameters is initially implanted to treat lesion with maximal CT-FFR drop (ΔCT-FFR); 2) if the simulated post-PCI CT-FFR is ≥0.90, no further intervention will be performed, and the simulated optimal treatment strategy is determined. If simulated post-PCI CT-FFR is <0.90, the "Imaging-Heart Team" would then have the following options: a) if there is a CT-FFR drop ≥0.05 across the virtual stented segment(s), the parameters of virtual stent(s) would be optimized (i.e., number of stents, stent diameter, and stent length); b) if there is a CT-FFR drop ≥0.05 across a relatively focal (<20mm) unstented segment (without virtual stenting) which is suitable for further stenting then a further virtual stent would be implanted; c) simulated post-PCI CT-FFR remains <0.90 after steps a and/or b: if either of the above criteria remain, option of further optimization of virtual stent parameters or one more additional virtual stent. Following this, the result will be accepted. d) if the simulated CT-FFR gradient is interpreted to reflect diffuse atherosclerosis with no focal CT-FFR drop, the result is accepted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual stenting-guided incremental optimization strategy (VIOS) | Experimental | Other: Virtual stent-guided incremental optimization strategy (VIOS)Virtual Stenting analysis is conducted based on pre-PCI CCTA angiograms by "Imaging-Heart Team" to determine simulated optimal treatment strategy according VIOS protocol. If the patient is assigned to the VIOS, the result of virtual stenting and recommended treatment strategy will be disclosed to the operator. The operator will then follow the recommended strategy to attempt to obtain the target optimal post-PCI FFR result. Blinded FFR must be obtained after PCI. |
| Standard angiographic strategy | Sham comparator | Other: Standard angiographic strategyVirtual Stenting analysis is conducted based on pre-PCI CCTA angiograms by "Imaging-Heart Team" to determine simulated optimal treatment strategy according VIOS protocol. If the patient is assigned to the standard angiographic strategy, the result of virtual stenting and recommended treatment strategy will be blinded to the operator. The operator will then perform PCI based on international guidelines, local protocols and practice. Blinded FFR must be obtained after PCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- General Inclusion Criteria
- Age ≥ 18 years.
- Able to understand the trial design and provide written informed consent.
- Patients with a coronary CTA performed within 30 days.
- CCTA Inclusion Criteria
Key exclusion criteria (13 listed)
- General Exclusion Criteria
- Cardiogenic shock or severe heart failure (NYHA ≥III or LVEF<30%).
- Severely impaired renal function: creatinine >150μmol/L or Cockcroft-Gault calculated GFR <45 ml/kg/1.73 m2 (calculated with Cockcroft-Gault formula).
- Allergy to iodine-containing contrast agents which cannot be adequately premedicated.
- CCTA Exclusion Criteria
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 |
|---|---|---|
| Virtual stent-guided incremental optimization strategy (VIOS)Also: VIOS-based PCIPCI is performed according to strategy recommended by "Imaging-Heart Team" based on VIOS protocol. | Other | Virtual stenting-guided incremental optimization strategy (VIOS) |
| Standard angiographic strategyAlso: angio-based PCIPCI is performed based on international guidelines, local protocols and practice. | Other | Standard angiographic strategy |
Primary outcome
The proportion of patients with a final post-PCI FFR result ≥0.90
Time frame: 1 days
The proportion of patients with a final post-PCI FFR result ≥0.90 will be compared between the randomised groups
10 secondary outcomes
The proportion of patients with final post-PCI FFR ≤0.80
Time frame: 1 days
The rate of target vessel failure (TVF) and its component features at 6 months.
Time frame: 6 months
The rate of target vessel failure (TVF) and its component features at 1 year.
Time frame: 1 year
Change from baseline in self-reported Health-related quality of life evaluation at 6 months.
Time frame: 6 months
Change from baseline in self-reported Health-related quality of life evaluation at 1 year.
Time frame: 1 year
Change from baseline in self-reported Angina status evaluation at 6 months.
Time frame: 6 months
Change from baseline in self-reported Angina status evaluation at 1 year.
Time frame: 1 year
Procedure Duration
Time frame: 1 day
Fluoroscopy Dose
Time frame: 1 day
Contrast Material Dose
Time frame: 1 day
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 12 Aug 2025.
- Background: PubMed 35798401Sonck J, Nagumo S, Norgaard BL, Otake H, Ko B, Zhang J, Mizukami T, Maeng M, Andreini D, Takahashi Y, Jensen JM, Ihdayhid A, Heggermont W, Barbato E, Mileva N, Munhoz D, Bartunek J, Updegrove A, Collinsworth A, Penicka M, Van Hoe L, Leipsic J, Koo BK, De Bruyne B, Collet C. Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography. JACC Cardiovasc Imaging. 2022 Jul;15(7):1242-1255. doi: 10.1016/j.jcmg.2022.02.003. Epub 2022 Apr 13.
- Background: PubMed 36898939Biscaglia S, Verardi FM, Tebaldi M, Guiducci V, Caglioni S, Campana R, Scala A, Marrone A, Pompei G, Marchini F, Scancarello D, Pignatelli G, D'Amore SM, Colaiori I, Demola P, Di Serafino L, Tumscitz C, Penzo C, Erriquez A, Manfrini M, Campo G. QFR-Based Virtual PCI or Conventional Angiography to Guide PCI: The AQVA Trial. JACC Cardiovasc Interv. 2023 Apr 10;16(7):783-794. doi: 10.1016/j.jcin.2022.10.054. Epub 2023 Mar 8.
- Background: PubMed 34279606Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.
- Background: PubMed 35101540Zhang R, Xu B, Dou K, Guan C, Zhao Y, Wang X, Zou T, Qiao Z, Xie L, Wang H, Yuan S, Song L, Tu S, Wang Y, Wijns W. Post-PCI outcomes predicted by pre-intervention simulation of residual quantitative flow ratio using augmented reality. Int J Cardiol. 2022 Apr 1;352:33-39. doi: 10.1016/j.ijcard.2022.01.054. Epub 2022 Jan 31.
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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.
Kefei Dou, MD, PhD principal investigator
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual stent-guided incremental optimization strategy (VIOS) and Standard angiographic strategy in people with Percutaneous Coronary Intervention and Coronary Physiology, run by China National Center for Cardiovascular Diseases 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 10 inclusion and 13 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 12 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
The proportion of patients with a final post-PCI FFR result ≥0.90 (time frame: 1 days). 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 NCT06280638, which also lists 7 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 12 Aug 2025; AzTrials last refreshed its copy on 4 Nov 2026.