Clinical trial NCT06280638: CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS)
Official title: Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Percutaneous Coronary Intervention
Coronary Physiology
Computed Tomography
Keywords: Percutaneous Coronary Intervention
Coronary Physiology
Computed Tomography
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-02-28
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients with a final post-PCI FFR result ≥0.90
timeFrame: 1 days
Secondary outcomes:
measure: The proportion of patients with final post-PCI FFR ≤0.80
timeFrame: 1 days
measure: The rate of target vessel failure (TVF) and its component features at 6 months.
timeFrame: 6 months
measure: The rate of target vessel failure (TVF) and its component features at 1 year.
timeFrame: 1 year
measure: Change from baseline in self-reported Health-related quality of life evaluation at 6 months.
timeFrame: 6 months
measure: Change from baseline in self-reported Health-related quality of life evaluation at 1 year.
timeFrame: 1 year
measure: Change from baseline in self-reported Angina status evaluation at 6 months.
timeFrame: 6 months
measure: Change from baseline in self-reported Angina status evaluation at 1 year.
timeFrame: 1 year
measure: Procedure Duration
timeFrame: 1 day
measure: Fluoroscopy Dose
timeFrame: 1 day
measure: Contrast Material Dose
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Kefei Dou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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