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Recruiting NCT05923489

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

No phase Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine Angiography Follow-up, Routine Clinical Follow-up.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina [Time frame: 24 months]
Secondary outcome measures (10)
  • Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina [Time frame: 60 months]
  • All-cause death [Time frame: 24 and 60 months]
  • Myocardial infarction [Time frame: 24 and 60 months]
  • Hospitalization for unstable angina [Time frame: 24 and 60 months]
  • Cardiac death [Time frame: 24 and 60 months]
  • Invasive angiography during follow-up [Time frame: 24 and 60 months]
  • Any revascularization [Time frame: 24 and 60 months]
  • Revascularization of any target vessel/lesion [Time frame: 24 and 60 months]
  • Revascularization of any non-target vessel/lesion [Time frame: 24 and 60 months]
  • Health Economics Analysis (cost-effectiveness) [Time frame: 24 and 60 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT05923489 · 2023-0332

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗