Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients
- Conditions
- Coronary Artery Disease
- Interventions
- Diagnostic Test: Routine Angiography Follow-upDiagnostic Test: Routine Clinical Follow-up
- Registration Number
- NCT05923489
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2618
- Age ≥ 18 years.
- Successful PCI with at least two of the following high-risk factors:
A. Left main lesion; B. Bifurcation lesion (true bifurcation); C. Ostial lesion of main vessels (left anterior descending, left circumflex artery, right coronary artery); D. Chronic total occlusion; E. Multivessel revascularization (≥ 2 vessels); F. In-stent restenosis; G. Diffuse long lesion (lesion length ≥ 30 mm or stent length ≥ 38 mm); H. Severe calcified lesion (Significant severe calcification on angiography); I. Bypass graft lesion; J. Diabetes mellitus; K. Chronic kidney disease (defined as an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 of body-surface area or the receipt of dialysis); L. Myocardial infarction;
- He/she or his/her legally authorized representative provides written informed
- Revascularization with bare metal stents and/or balloon angioplasty with non-drug-coated balloons.
- Pregnant and/or lactating women.
- Life expectancy of less than 2 years.
- Repeat interventional therapy is planned.
- Subject was unable to provide written informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine Angiography Follow-up (RAF) group Routine Angiography Follow-up Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization. Routine Clinical Follow-up (RCF) group Routine Clinical Follow-up Patients in the RCF group will have routine clinical follow-up at 12 months after revascularization, and the physician will decide whether further invasive testing is needed.
- Primary Outcome Measures
Name Time Method Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina 24 months The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
- Secondary Outcome Measures
Name Time Method Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina 60 months The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
Invasive angiography during follow-up 24 and 60 months The rate of invasive angiography during follow-up
Revascularization of any target vessel/lesion 24 and 60 months The rate of revascularization of any target vessel/lesion
Revascularization of any non-target vessel/lesion 24 and 60 months The rate of revascularization of any non-target vessel/lesion
Health Economics Analysis (cost-effectiveness) 24 and 60 months All-cause death 24 and 60 months The rate of all-cause death
Myocardial infarction 24 and 60 months The rate of myocardial infarction
Hospitalization for unstable angina 24 and 60 months The rate of hospitalization for unstable angina
Any revascularization 24 and 60 months The rate of any revascularization during follow-up (ischemia-driven vs. all-cause)
Cardiac death 24 and 60 months The rate of hospitalization for cardiac death
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China