Clinical trial NCT05923489: Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients
Official title: Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients (The REVISE Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jinhua Central Hospital
name: Changxing People's Hospital
name: The Affiliated Hospital of Hangzhou Normal University
name: Second Affiliated Hospital of Shantou University Medical College
name: Dongyang People's Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Huizhou Municipal Central Hospital
name: First Affiliated Hospital of Ningbo University
First posted: 2023-06-28
Enrollment: 2618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.


Eligibility criteria: 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.

Primary outcomes:
measure: Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
timeFrame: 24 months
Secondary outcomes:
measure: Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
timeFrame: 60 months
measure: All-cause death
timeFrame: 24 and 60 months
measure: Myocardial infarction
timeFrame: 24 and 60 months
measure: Hospitalization for unstable angina
timeFrame: 24 and 60 months
measure: Cardiac death
timeFrame: 24 and 60 months
measure: Invasive angiography during follow-up
timeFrame: 24 and 60 months
measure: Any revascularization
timeFrame: 24 and 60 months
measure: Revascularization of any target vessel/lesion
timeFrame: 24 and 60 months
measure: Revascularization of any non-target vessel/lesion
timeFrame: 24 and 60 months
measure: Health Economics Analysis (cost-effectiveness)
timeFrame: 24 and 60 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: