Coronary Artery Disease
Conditions
Keywords
percutaneous coronary intervention
Brief summary
Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.
Interventions
DIAGNOSTIC_TESTRoutine Angiography Follow-up
Patients in the RAF group will have routine angiography follow-up at 12±3 months after revascularization.
DIAGNOSTIC_TESTRoutine Clinical Follow-up
Patients in the RCF group will have routine clinical follow-up at 12±3 months after revascularization, and the further interventions can be performed at the discretion of the physician according to the current standard.
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Jinhua Central Hospital
Changxing People's Hospital
The Affiliated Hospital of Hangzhou Normal University
Second Affiliated Hospital of Shantou University Medical College
Dongyang People's Hospital
First Affiliated Hospital of Wenzhou Medical University
Huzhou Central Hospital
First Affiliated Hospital of Ningbo University
The First People's Hospital of Linping District
The Sixth People's Hospital of Xinjiang Uygur Autonomous Region
Ningbo Medical Center Lihuili Hospital
The Eighth People's Hospital of JiNan
The First Affiliated Hospital of Nanchang University
Ruian People's Hospital of Zhejiang Province
Shaoxing Central Hospital
The Second People's Hospital of Quzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Cardiac death | 24 and 60 months | The rate of hospitalization for cardiac death |
| Invasive angiography during follow-up | 24 and 60 months | The rate of invasive angiography during follow-up |
| Any revascularization | 24 and 60 months | The rate of any revascularization during follow-up (ischemia-driven vs. all-cause) |
| 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 |
Countries
China
Contacts
CONTACTJun Jiang, MD, PhD
CONTACTJinlong Zhang, MD, PhD
Outcome results
None listed