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

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Routine Angiography Follow-up
Routine Clinical Follow-up
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Routine Angiography Follow-up (RAF) group

    Routine Clinical Follow-up (RCF) group

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 20, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    Jinhua Central Hospital, Changxing People's Hospital, The Affiliated Hospital of Hangzhou Normal University, Second Affiliated Hospital of Shantou University Medical College, Dongyang People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Huizhou Municipal Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05923489
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    October 15, 2026 (Anticipated)
    Study Completion Date
    October 15, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    Jinhua Central Hospital, Changxing People's Hospital, The Affiliated Hospital of Hangzhou Normal University, Second Affiliated Hospital of Shantou University Medical College, Dongyang People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Huizhou Municipal Central Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2618 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Routine Angiography Follow-up (RAF) group
    Arm Type
    Experimental
    Arm Description
    Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.
    Arm Title
    Routine Clinical Follow-up (RCF) group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Routine Angiography Follow-up
    Intervention Description
    Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Routine Clinical Follow-up
    Intervention Description
    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 Measure Information:
    Title
    Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
    Description
    The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
    Description
    The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
    Time Frame
    60 months
    Title
    All-cause death
    Description
    The rate of all-cause death
    Time Frame
    24 and 60 months
    Title
    Myocardial infarction
    Description
    The rate of myocardial infarction
    Time Frame
    24 and 60 months
    Title
    Hospitalization for unstable angina
    Description
    The rate of hospitalization for unstable angina
    Time Frame
    24 and 60 months
    Title
    Cardiac death
    Description
    The rate of hospitalization for cardiac death
    Time Frame
    24 and 60 months
    Title
    Invasive angiography during follow-up
    Description
    The rate of invasive angiography during follow-up
    Time Frame
    24 and 60 months
    Title
    Any revascularization
    Description
    The rate of any revascularization during follow-up (ischemia-driven vs. all-cause)
    Time Frame
    24 and 60 months
    Title
    Revascularization of any target vessel/lesion
    Description
    The rate of revascularization of any target vessel/lesion
    Time Frame
    24 and 60 months
    Title
    Revascularization of any non-target vessel/lesion
    Description
    The rate of revascularization of any non-target vessel/lesion
    Time Frame
    24 and 60 months
    Title
    Health Economics Analysis (cost-effectiveness)
    Time Frame
    24 and 60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Jiang, MD, PhD
    Phone
    +86 0571 87784808
    Email
    jiang-jun@zju.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jinlong Zhang, MD, PhD
    Phone
    +86 15757197513
    Email
    jinlong1102@zju.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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