In-stent restenosis
Conditions
Interventions
Treatment group:Optical coherence tomography guides percutaneous coronary intervention.
Control group:Coronary angiography guides percutaneous coronary intervention.
Sponsors
Affiliated Hospital of Zunyi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Eligibility and Age: --Subject must be eligible for PCI. --Subject must be at least 18 years old. 2. ISR Types: In-stent restenosis of all patterns (Types ?-IV). 3. Informed Consent: The subject or a legally authorized representative must understand the study requirements, agree to the treatment procedures, and provide written informed consent before any study-specific procedures are performed. 4. Compliance: The subject must demonstrate a willingness and ability to comply with all protocol requirements. 5. Angiographic Criteria: --Stent Diameter: Previous stent diameter between 2.5 mm and 4.0 mm. --ISR Severity: ISR with diameter stenosis =90%, or =50% with evidence of ischemia, including any of the following: -Typical angina symptoms. -ECG ischemic changes. -Invasive tests such as QFR or FFR <0.8. -Ischemic findings confirmed by SPECT, PET, CMR, CT-FFR < 0.8 or exercise stress tests. --Number of Lesions: A maximum of two ISR lesions in two major epicardial vessels require treatment. --Non-ISR Lesions: Non-ISR lesions (ischemia-related) in either stented or non-stented vessels must be treated using the same guidance as the randomization for ISR lesions.
Exclusion criteria
Exclusion criteria: 1. Left ventricular ejection fraction (LVEF) < 25%. 2. Hemodynamic instability. 3. Cardiogenic shock. 4. STEMI or QWMI within 72 hours before the index procedure. 5. Severe renal insufficiency (glomerular filtration rate <20ml/min/1.73m²). 6. Moderate to severe hepatic dysfunction (characterized by ALT/AST levels exceeding three times the upper limit of normal). 7. Platelet count <100,000 mm3. 8. Contraindications to anticoagulant and antiplatelet therapy. 9. History of stroke within the past 3 months, any permanent neurological deficit, previous intracranial hemorrhage, or any intracranial pathology such as aneurysm or arteriovenous fistula. 10. Planned surgery during the study period. 11. Women of childbearing potential. 12. Severe psychiatric disorders resulting in the inability to provide informed consent. 13. Life expectancy of less than 1 year. 14. Presence of any other significant abnormal signs, laboratory findings, or clinical conditions that, the investigator’s opinion, make the participants unsuitable for inclusion in the study. 15. Angiographic exclusion criteria: (1) The target lesion is located within the saphenous vein or transplanted artery. (2) The target lesion is located in the left main coronary artery or involves ostial lesions. (3) The target lesion is located in the extreme distal segment of the vessel. (4) Thrombus-containing lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target vessel failure (TVF);Incidence of contrast-induced nephropathy; | — |
Secondary
| Measure | Time frame |
|---|---|
| TVF without procedure-related myocardial infarction;Cardiovascular death;All-cause mortality;Target vessel-related myocardial infarction;PCI-related myocardial infarction;Spontaneous myocardial infarction;Ischemia-drived target lesion revascularization;Clinically driven target lesion revascularization;Proportion of procedure optimization; | — |
Countries
China
Contacts
Public ContactBei Shi
Affiliated Hospital of Zunyi Medical University
Outcome results
None listed