Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
294 participants
INTERVENTIONAL
2022-12-12
2025-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Usual Care
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.
Usual Care
Participants randomized to usual care will be evaluated according to institutional standard practice.
CT-FFR
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.
CT-FFR
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.
Interventions
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CT-FFR
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.
Usual Care
Participants randomized to usual care will be evaluated according to institutional standard practice.
Eligibility Criteria
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Inclusion Criteria
* (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
* (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.
18 Years
ALL
No
Sponsors
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Yan'an Affiliated Hospital of Kunming Medical University
OTHER
Responsible Party
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Principal Investigators
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Qiang Xue
Role: PRINCIPAL_INVESTIGATOR
Yan'an Affiliated Hospital of Kunming Medical University
Central Contacts
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Other Identifiers
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In-stent Restenosis
Identifier Type: -
Identifier Source: org_study_id
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