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IVUS versus OCT Guided PCI for Left Main Distal Bifurcation Lesions

IVUS versus OCT Guided PCI for Left Main Distal Bifurcation Lesions——Multicenter, open, blinded evaluation, randomized controlled, non-inferiority clinical trial design

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061120
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-11
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Coronary Artery Disease

Interventions

IVUS guided:IVUS
OCT guided:OCT

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The age is over 18 years old, and the gender is not limited; 2. LM terminal in situ bifurcation lesions (visual inspection of Medina 1,1,1 or 0,1,1); 3. The anatomical structure is suitable for PCI; 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. STEMI occurred within 1 month before screening; 2. Patients who have previously undergone LM percutaneous coronary stenting (PCI) or coronary artery bypass grafting (CABG); 3. Patients with lesions involving the opening of the LM; 4. Patients with chronic total occlusion (CTO) lesions requiring intervention; 5. Patients with cardiogenic shock, pulmonary edema or LVEF 5 times the upper limit of normal) or renal insufficiency (eGRF<30mL/min/1.73m^2); 7. Patients who are to be implanted with bare stent (BMS)\bioresorbable stent (BVS); 8. Patients with second and third degree atrioventricular block (AVB) or malignant ventricular arrhythmia; 9. Patients with severe valve disease; 10. Ischemic cerebrovascular events occurred within half a year, or patients with residual neurological disorders; 11. Patients who cannot tolerate dual antiplatelet therapy after surgery; 12. Severe diseases with a life expectancy of less than 12 months, such as cancer, other advanced diseases, etc.; 13. Patients with active infection; 14. Hgb < 90g/L; 15. Active bleeding and obvious bleeding tendency, such as active ulcer, history of hemorrhagic stroke, intracranial space-occupying lesions, recent craniocerebral trauma, active bleeding of other organs that are not easy to stop bleeding, etc.; 16. Pregnant and lactating women; 17. Females of childbearing age with positive blood pregnancy or urine pregnancy test results within 24 hours before study treatment; 18. Males and females with reproductive potential do not use effective contraceptive measures or do not agree to continue to take effective contraceptive measures for at least 6 months after the last study drug administration; 19. Investigators believe that those who are not suitable for inclusion in this trial.

Design outcomes

Primary

MeasureTime frame
12-month postoperative target lesion failure rate;

Secondary

MeasureTime frame
Cardiogenic death 12 months postoperatively;Target lesion-related myocardial infarction 12 months postoperatively;Ischemia-driven target lesion revascularization 12 months postoperatively;

Countries

China

Contacts

Public ContactYong Zeng

Beijing Anzhen Hospital, Capital Medical University

13501373114@163.com+86 13501373114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026