Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients

Coronary Artery Disease Clinical Trial

Official title:

Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients (The REVISE Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923489
• Other study ID #: 2023-0332
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2023
• Est. completion date: October 15, 2029

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jun Jiang, MD, PhD
• Phone: +86 0571 87784808
• Email: jiang-jun[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2618
• Est. completion date: October 15, 2029
• Est. primary completion date: October 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Routine Angiography Follow-up
Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.
• 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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (9)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Changxing People's Hospital, Dongyang People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Huizhou Municipal Central Hospital, Jinhua Central Hospital, Second Affiliated Hospital of Shantou University Medical College, The Affiliated Hospital of Hangzhou Normal University, The First Affiliated Hospital of Ningbo University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina	The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina	24 months
Secondary	Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina	The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina	60 months
Secondary	All-cause death	The rate of all-cause death	24 and 60 months
Secondary	Myocardial infarction	The rate of myocardial infarction	24 and 60 months
Secondary	Hospitalization for unstable angina	The rate of hospitalization for unstable angina	24 and 60 months
Secondary	Cardiac death	The rate of hospitalization for cardiac death	24 and 60 months
Secondary	Invasive angiography during follow-up	The rate of invasive angiography during follow-up	24 and 60 months
Secondary	Any revascularization	The rate of any revascularization during follow-up (ischemia-driven vs. all-cause)	24 and 60 months
Secondary	Revascularization of any target vessel/lesion	The rate of revascularization of any target vessel/lesion	24 and 60 months
Secondary	Revascularization of any non-target vessel/lesion	The rate of revascularization of any non-target vessel/lesion	24 and 60 months
Secondary	Health Economics Analysis (cost-effectiveness)		24 and 60 months