NCT06280638Completed

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

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

Source: ClinicalTrials.gov · Last updated 12 Aug 2025

Brief summary (registry, in English)

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).

Status (registry): Completed
Study type: Interventional
Enrollment: 280 (actual)
First submitted: 11 Feb 2024
Start date: 5 Mar 2024
Primary completion date: 23 Jun 2025
Lead sponsor: China National Center for Cardiovascular Diseases
Diseases: Coronary artery disease
NCT number: NCT06280638

What you commit to

Study type: Interventional
Participants enrolled: 280
From 5 Mar 2024 to the primary completion date, 23 Jun 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Allergy to iodine-containing contrast agents which cannot be adequately premedicated.
- CCTA Exclusion Criteria

Lab values

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).

Other

General Exclusion Criteria
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.
- Angiographic Exclusion Criteria
The interrogated vessel with only 1 coronary artery lesion with DS \>90% with TIMI flow \<3.
Coronary lesions favor CABG treatment.

Who the study is looking for

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.
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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status	Beijing	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.