Using virtual stenting to improve coronary artery procedures

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

This study is testing whether using virtual stenting based on CT scans can help improve heart procedures for patients who still have problems after their arteries are opened up.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (other gov)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06280638 on ClinicalTrials.gov

What this trial studies

This study aims to enhance the outcomes of percutaneous coronary interventions (PCI) by utilizing computed tomography (CT) derived virtual stenting to optimize coronary revascularization. It addresses the issue of patients who, despite having anatomically successful PCI, continue to experience unresolved ischemia and related complications. The approach involves simulating post-stenting physiology based on pre-PCI CT angiograms, allowing for better decision-making during the procedure. By comparing this virtual stent-guided strategy with standard angiographic methods, the study seeks to determine if it can lead to improved functional results and reduced adverse events.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific coronary artery lesions suitable for intervention and recent CT angiograms.

Not a fit: Patients with severe heart failure, cardiogenic shock, or significant renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of recurrent angina and improve long-term outcomes for patients undergoing PCI.

How similar studies have performed: While there have been studies on PCI optimization, this specific approach using CT-derived virtual stenting is relatively novel and has not been extensively tested.

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.

Where this trial is running

Beijing, Beijing

• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Kefei Dou, MD, PhD — Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
• Study coordinator: Chenggang Zhu, MD, PhD

Conditions: Percutaneous Coronary Intervention, Coronary Physiology, Computed Tomography