Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05923489

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Jun Jiang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine Angiography Follow-up

Diagnostic Test

Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.

Routine Clinical Follow-up

Diagnostic Test

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 outcomes

  1. Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina

    Time frame: 24 months

    The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina

Secondary outcomes

  1. Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina

    Time frame: 60 months

    The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina

  2. All-cause death

    Time frame: 24 and 60 months

    The rate of all-cause death

  3. Myocardial infarction

    Time frame: 24 and 60 months

    The rate of myocardial infarction

  4. Hospitalization for unstable angina

    Time frame: 24 and 60 months

    The rate of hospitalization for unstable angina

  5. Cardiac death

    Time frame: 24 and 60 months

    The rate of hospitalization for cardiac death

  6. Invasive angiography during follow-up

    Time frame: 24 and 60 months

    The rate of invasive angiography during follow-up

  7. Any revascularization

    Time frame: 24 and 60 months

    The rate of any revascularization during follow-up (ischemia-driven vs. all-cause)

  8. Revascularization of any target vessel/lesion

    Time frame: 24 and 60 months

    The rate of revascularization of any target vessel/lesion

  9. Revascularization of any non-target vessel/lesion

    Time frame: 24 and 60 months

    The rate of revascularization of any non-target vessel/lesion

  10. Health Economics Analysis (cost-effectiveness)

    Time frame: 24 and 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jinlong Zhang, MD, PhD

CONTACT

[email protected]

+86 15757197513

Jun Jiang, MD, PhD

CONTACT

[email protected]

+86 0571 87784808

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Changxing People's Hospital
  • Dongyang People's Hospital
  • First Affiliated Hospital of Ningbo University
  • 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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Jun 28, 2023
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.