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CT-FFR-guided Strategy for In-stent Restenosis

Primary Purpose

Coronary Artery Disease, In-stent Restenosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CT-FFR
Usual Care
Sponsored by
Yan'an Affiliated Hospital of Kunming Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary CT Angiography-derived Fractional Flow Reserve, In-stent Restenosis, Major Adverse Coronary Events

Eligibility Criteria

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

Inclusion Criteria: (1) >18 years old; (2) ability to provide informed consent; (3) previous PCI who underwent CCTA and have at least 1 lesion with a percent diameter in-stent stenosis between 30% and 90% in a coronary artery with a ≥2.25 mm reference vessel diameter by visual assessment; (4) accepted further clinically indicated coronary testing, coronary arteriography, or FFR, or IVUS, or PCI, etc. Exclusion Criteria: (1) Prior coronary artery bypass surgery (CABG), heart valve surgery, cardiac pacemaker, or implanted cardiac defibrillator; (2) Target vascular stents were evaluated for implantation within one month; (3) unstable clinical conditions including acute chest pain, cardiogenic shock, congestive heart failure (NYHA grade III or IV), unstable blood pressure (systolic blood pressure < 90mmHg) or acute pulmonary edema; (4) Acute myocardial infarction occurred within 7 days before enrollment, and left ventricular ejection fraction ≤40%; (5) Other severe cases are not suitable for clinical trials including complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and severe chronic renal damage; (6) Contraindication to beta blockers, nitroglycerin, adenosine, or allergy to iodine contrast agents; (7) Pregnancy or pregnancy status unknown; (8) Life expectancy <1 years; (9)Repeated enrollment; (10) Any other factors that other researchers consider not suitable for inclusion or completion of this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Usual Care

    CT-FFR

    Arm Description

    Participants randomized to usual care will be evaluated according to institutional standard practice. The investigators will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice.

    Participants randomized to a CT-FFR strategy will be assigned to non-invasive CT-FFR evaluation. The investigators will review the results CT-FFR, and will recommend a further ICA test if CT-FFR≤0.8. The investigators will review the results of all available diagnostic tests, including CT-FFR and ICA, and will recommend a treatment strategy accordingly.

    Outcomes

    Primary Outcome Measures

    12-month MACE
    12-month Major Adverse Coronary Event (MACE) rates, defined as: All cause death Non-fatal myocardial infarction (MI) Ischemia-driven target vessel revascularization (TVR)

    Secondary Outcome Measures

    MACE
    MACE defined as: All cause death Non-fatal MI Clinical-driven TVR
    Rates of Target lesion failure (TLF)
    Composite of clinically driven TLR, MI or cardiac death related to the target vessel.
    Total costs
    Total costs will be calculated from the use of all cardiac-related invasive and non-invasive tests, revascularization procedures, hospital admissions and outpatient attendances due to a cardiovascular cause, and cardiac medications.
    Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire
    Quality of life (QOL), will be assessed using the EQ-5D-VAS questionnaire
    Seattle Angina Questionnaire
    angina status, will be assessed using the Seattle Angina Questionnaire
    Cumulative radiation exposure
    Cumulative radiation exposure within 6-month and 12-month of study entry included all cardiovascular tests and invasive procedures, including CTA, myocardial perfusion imaging, and ICA.

    Full Information

    First Posted
    November 3, 2022
    Last Updated
    November 8, 2022
    Sponsor
    Yan'an Affiliated Hospital of Kunming Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05611190
    Brief Title
    CT-FFR-guided Strategy for In-stent Restenosis
    Official Title
    Coronary CT Angiography-Derived Fractional Flow Reserve-guided Optimize Treatment Strategy for In-stent Restenosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 12, 2022 (Anticipated)
    Primary Completion Date
    December 11, 2024 (Anticipated)
    Study Completion Date
    December 11, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yan'an Affiliated Hospital of Kunming Medical University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study will be a prospective, randomized clinical trial to compare standard practice guided by usual care testing to CT-FFR-guided management in patients with in-stent restenosis.
    Detailed Description
    This trial will randomize 294 patients with in-stent restenosis to receive either CT-FFR or routine clinical assessment. In all subjects, the investigators will review all diagnostic test results and determine a treatment strategy. The primary end point will be 12-month Major Adverse Coronary Event (MACE) rates, defined as all cause death, non-fatal myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR). Secondary end points will include total medical costs, and quality of life (QOL), medical radiation exposure, etc. We will test noninferiority of current FFR-guided strategy compared with standard care strategy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, In-stent Restenosis
    Keywords
    Coronary CT Angiography-derived Fractional Flow Reserve, In-stent Restenosis, Major Adverse Coronary Events

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    294 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    Other
    Arm Description
    Participants randomized to usual care will be evaluated according to institutional standard practice. The investigators will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice.
    Arm Title
    CT-FFR
    Arm Type
    Experimental
    Arm Description
    Participants randomized to a CT-FFR strategy will be assigned to non-invasive CT-FFR evaluation. The investigators will review the results CT-FFR, and will recommend a further ICA test if CT-FFR≤0.8. The investigators will review the results of all available diagnostic tests, including CT-FFR and ICA, and will recommend a treatment strategy accordingly.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    CT-FFR
    Intervention Description
    CT-FFR is a type of non-invasive procedure to provide a 3D model of coronary arteries as a way to evaluate the hemodynamic significance of coronary artery lesions. CT-FFR calculates FFR from subject-specific CCTA data using computational fluid dynamics technology. CT-FFR value ≤0.80 is considered hemodynamically significant.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Usual Care
    Intervention Description
    Participants randomized to usual care will be evaluated according to institutional standard practice.
    Primary Outcome Measure Information:
    Title
    12-month MACE
    Description
    12-month Major Adverse Coronary Event (MACE) rates, defined as: All cause death Non-fatal myocardial infarction (MI) Ischemia-driven target vessel revascularization (TVR)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    MACE
    Description
    MACE defined as: All cause death Non-fatal MI Clinical-driven TVR
    Time Frame
    3-month, 6-month, 24-month, 36-month
    Title
    Rates of Target lesion failure (TLF)
    Description
    Composite of clinically driven TLR, MI or cardiac death related to the target vessel.
    Time Frame
    3-month, 6-month, 24-month, 36-month
    Title
    Total costs
    Description
    Total costs will be calculated from the use of all cardiac-related invasive and non-invasive tests, revascularization procedures, hospital admissions and outpatient attendances due to a cardiovascular cause, and cardiac medications.
    Time Frame
    6-month, 12-month
    Title
    Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire
    Description
    Quality of life (QOL), will be assessed using the EQ-5D-VAS questionnaire
    Time Frame
    6-month, 12-month
    Title
    Seattle Angina Questionnaire
    Description
    angina status, will be assessed using the Seattle Angina Questionnaire
    Time Frame
    6-month, 12-month
    Title
    Cumulative radiation exposure
    Description
    Cumulative radiation exposure within 6-month and 12-month of study entry included all cardiovascular tests and invasive procedures, including CTA, myocardial perfusion imaging, and ICA.
    Time Frame
    6-month, 12-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) >18 years old; (2) ability to provide informed consent; (3) previous PCI who underwent CCTA and have at least 1 lesion with a percent diameter in-stent stenosis between 30% and 90% in a coronary artery with a ≥2.25 mm reference vessel diameter by visual assessment; (4) accepted further clinically indicated coronary testing, coronary arteriography, or FFR, or IVUS, or PCI, etc. Exclusion Criteria: (1) Prior coronary artery bypass surgery (CABG), heart valve surgery, cardiac pacemaker, or implanted cardiac defibrillator; (2) Target vascular stents were evaluated for implantation within one month; (3) unstable clinical conditions including acute chest pain, cardiogenic shock, congestive heart failure (NYHA grade III or IV), unstable blood pressure (systolic blood pressure < 90mmHg) or acute pulmonary edema; (4) Acute myocardial infarction occurred within 7 days before enrollment, and left ventricular ejection fraction ≤40%; (5) Other severe cases are not suitable for clinical trials including complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and severe chronic renal damage; (6) Contraindication to beta blockers, nitroglycerin, adenosine, or allergy to iodine contrast agents; (7) Pregnancy or pregnancy status unknown; (8) Life expectancy <1 years; (9)Repeated enrollment; (10) Any other factors that other researchers consider not suitable for inclusion or completion of this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qiang Xue
    Phone
    13987199913
    Email
    Xueqiang3513@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qiang Xue
    Organizational Affiliation
    Yan'an Affiliated Hospital of Kunming Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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