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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
294
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.
Participants randomized to usual care will be evaluated according to institutional standard practice.
12-month MACE
12-month Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death 2. Non-fatal myocardial infarction (MI) 3. Ischemia-driven target vessel revascularization (TVR)
Time frame: 12 months
MACE
MACE defined as: 1. All cause death 2. Non-fatal MI 3. Clinical-driven TVR
Time frame: 3-month, 6-month, 24-month, 36-month
Rates of Target lesion failure (TLF)
Composite of clinically driven TLR, MI or cardiac death related to the target vessel.
Time frame: 3-month, 6-month, 24-month, 36-month
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.
Time frame: 6-month, 12-month
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
Time frame: 6-month, 12-month
Seattle Angina Questionnaire
angina status, will be assessed using the Seattle Angina Questionnaire
Time frame: 6-month, 12-month
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.
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Time frame: 6-month, 12-month