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A Study of Virtual Stent Simulation to Improve Stent Treatment for Coronary Artery Disease

A Multicenter, Prospective, Randomized Controlled Trial of Preprocedural Physiological Optimization of Percutaneous Coronary Intervention Using Coronary Imaging–Physiology Fusion-Based Virtual Stenting Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127295
Enrollment
Unknown
Registered
2026-06-29
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

Angiography-Guided PCI:Standard Angiography-Guided PCI
Virtual Stenting-Guided PCI Optimization:Virtual Stenting-Guided PCI Optimization

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with coronary heart disease who are 18 years or older and are undergoing coronary angiography; 2. There is at least one lesion in a major coronary artery with an estimated reference vessel diameter of 2.5 mm or more, showing 70-95% narrowing based on visual assessment; 3. Pre-procedure calculated QFR of the target vessel is less than 0.8, and the lesion is technically feasible for percutaneous coronary intervention (PCI) based on angiographic evaluation; 4. Able to understand the trial design and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Clinical or angiographic features that can cause QFR calculation failure: (1) Left main coronary artery disease; (2) Lesions at the origin of the left branch or right coronary artery; (3) Previous coronary artery bypass graft surgery; (4) Persistent ventricular arrhythmia; (5) Chronic total occlusion lesions; (6) Target vessel stenosis over 95% with TIMI flow less than grade III; (7) Severe calcified lesions; (8) In-stent restenosis lesions. 2. PCI to the target artery provides Rentrop grade 2 or 3 collateral blood flow to another vessel; 3. Patients planned for drug-coated balloon treatment of coronary in-situ lesions; 4. Expected lifespan less than 1 year due to non-cardiac causes; 5. Cardiogenic shock or refractory hypotension (Killip class IV); 6. Use of intravenous vasoactive drugs, intra-aortic balloon pump, or other mechanical circulatory support devices; 7. Patients receiving endotracheal intubation; 8. After successful intravenous thrombolysis, patients who do not undergo angiography and necessary intervention within 24 hours; 9. Creatinine clearance < 30 ml/kg calculated by the Cockcroft-Gault formula; 10. Pregnant women; 11. Patients allergic to iodine-containing contrast agents; 12. Patients who are expected not to tolerate at least 6 months of antiplatelet therapy; 13. Patients planning any surgery within 6 months; 14. Other situations that may interfere with follow-up (such as dementia, substance abuse, etc.).

Design outcomes

Primary

MeasureTime frame
Major Adverse Cardiovascular Events (MACE);

Secondary

MeasureTime frame
Post-PCI Physiological Optimization Achievement Rate;

Countries

China

Contacts

Public ContactYing Song

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

jessiesong1983@aliyun.com+86 10 8832 2455

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026