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

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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Routine Angiography Follow-up; Diagnostic test: Routine Clinical Follow-up

• Study Type: Interventional
• Enrollment (Estimated): 2618
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Jiang, MD, PhD; Phone Number: +86 0571 87784808; Email: jiang-jun@zju.edu.cn
• Study Contact Backup: Name: Jinlong Zhang, MD, PhD; Phone Number: +86 15757197513; Email: jinlong1102@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Jun Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Routine Angiography Follow-up (RAF) group; Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.	Diagnostic test: Routine Angiography Follow-up; Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.
Active Comparator: Routine Clinical Follow-up (RCF) group; 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Economics Analysis (cost-effectiveness)		24 and 60 months
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
All-cause death	The rate of all-cause death	24 and 60 months
Myocardial infarction	The rate of myocardial infarction	24 and 60 months
Hospitalization for unstable angina	The rate of hospitalization for unstable angina	24 and 60 months
Cardiac death	The rate of hospitalization for cardiac death	24 and 60 months
Invasive angiography during follow-up	The rate of invasive angiography during follow-up	24 and 60 months
Any revascularization	The rate of any revascularization during follow-up (ischemia-driven vs. all-cause)	24 and 60 months
Revascularization of any target vessel/lesion	The rate of revascularization of any target vessel/lesion	24 and 60 months
Revascularization of any non-target vessel/lesion	The rate of revascularization of any non-target vessel/lesion	24 and 60 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2029

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2023-0332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No