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

NCT06280638 | Completed DMC

• 1 other identifier: 2023-2095
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Percutaneous Coronary Intervention; Coronary Physiology; Computed Tomography

Keywords

Percutaneous Coronary Intervention; Coronary Physiology; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• The proportion of patients with final post-PCI FFR ≤0.80

  1 days

• The rate of target vessel failure (TVF) and its component features at 6 months.

  6 months

• The rate of target vessel failure (TVF) and its component features at 1 year.

  1 year

• Change from baseline in self-reported Health-related quality of life evaluation at 6 months.

  6 months

• Change from baseline in self-reported Health-related quality of life evaluation at 1 year.

  1 year

Study Arms (2)

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.

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.

Other: Standard angiographic strategy

Interventions

Virtual stent-guided incremental optimization strategy (VIOS) OTHER

PCI is performed according to strategy recommended by "Imaging-Heart Team" based on VIOS protocol.

Also known as: VIOS-based PCI

Virtual stenting-guided incremental optimization strategy (VIOS)

Standard angiographic strategy OTHER

PCI is performed based on international guidelines, local protocols and practice.

Also known as: angio-based PCI

Standard angiographic strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Able to understand the trial design and provide written informed consent.
• Patients with a coronary CTA performed within 30 days.
• The CCTA angiograms amenable to CT-FFR measurement.
• 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.
• \. The interrogated vessel is indicated for intervention assessed by operator based on indications other than CT-FFR.

You may not qualify if:

• 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.
• The CCTA angiograms deems not amenable to CT-FFR measurement.
• 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.
• The interrogated vessel with only 1 coronary artery lesion with DS \>90% with TIMI flow \<3.
• Coronary lesions favor CABG treatment.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (7)

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  PMID: 35798401 BACKGROUND

• 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.

  PMID: 36898939 BACKGROUND

• 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.

  PMID: 34279606 BACKGROUND

• 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.

  PMID: 35101540 BACKGROUND

• 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.

  PMID: 34742368 BACKGROUND

• 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.

  PMID: 33822922 BACKGROUND

• 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.

  PMID: 30165437 BACKGROUND

Study Officials

• Kefei Dou, MD, PhD

  Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kefei Dou, MD, Professor, China National Center for Cardiovascular Diseases

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 28, 2024
• Study Start: March 5, 2024
• Primary Completion: June 23, 2025
• Study Completion: July 20, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

CN (1)