CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS)

Percutaneous Coronary Intervention Clinical Trial

— CT-COMPASS  

Official title:

Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280638
• Other study ID #: 2023-2095
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Chenggang Zhu, MD, PhD
• Phone: 86-10-88396861
• Email: fuwaizcg[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

General Inclusion Criteria

1. Age = 18 years.

2. Able to understand the trial design and provide written informed consent.

3. Patients with a coronary CTA performed within 30 days.

CCTA Inclusion Criteria

1. The CCTA angiograms amenable to CT-FFR measurement.

2. At least 1 lesion of 50%-90% diameter stenosis in a coronary artery with =2.0mm reference vessel diameter by visual assessment.

3. 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.

Exclusion Criteria

General Exclusion Criteria

1. Cardiogenic shock or severe heart failure (NYHA =III or LVEF<30%).

2. Severely impaired renal function: creatinine >150µmol/L or Cockcroft-Gault calculated GFR <45 ml/kg/1.73 m2 (calculated with Cockcroft-Gault formula).

3. Allergy to iodine-containing contrast agents which cannot be adequately premedicated.

CCTA Exclusion Criteria

1. The CCTA angiograms deems not amenable to CT-FFR measurement.

2. Patients with only 1 coronary artery lesion with DS >90% with TIMI flow <3.

3. An interrogated vessel presented with a CTO lesion.

4. All coronary arteries were not physiologically ischemic.

5. Coronary lesions favor CABG treatment.

Angiographic Exclusion Criteria

1. The interrogated vessel with only 1 coronary artery lesion with DS >90% with TIMI flow <3.

2. Coronary lesions favor CABG treatment.

Related Conditions & MeSH terms

• Computed Tomography
• Coronary Physiology
• Percutaneous Coronary Intervention

Intervention

Other:
• Virtual stent-guided incremental optimization strategy (VIOS)
PCI is performed according to strategy recommended by "Imaging-Heart Team" based on VIOS protocol.
• Standard angiographic strategy
PCI is performed based on international guidelines, local protocols and practice.

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (7)

Biscaglia 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. — View Citation

Collison 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. — View Citation

Ding 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. — View Citation

Neumann 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. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096. — View Citation

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. — View Citation

Xu 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. — View Citation

Zhang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 days
Secondary	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	1 days
Secondary	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.	6 months
Secondary	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.	1 year
Secondary	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	6 months
Secondary	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	1 year
Secondary	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	6 months
Secondary	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	1 year
Secondary	Procedure Duration	The time required to perform the VIOS intervention procedures will be compared with those in the control group.	1 day
Secondary	Fluoroscopy Dose	The radiation doses for the VIOS intervention procedures will be compared with those in the control group.	1 day
Secondary	Contrast Material Dose	The contrast material doses for the VIOS intervention procedures will be compared with those in the control group.	1 day