Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Other | 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. |
|
| CT-FFR | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-FFR | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month MACE | 12-month Major Adverse Coronary Event (MACE) rates, defined as:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | MACE defined as:
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Xue | Contact | 13987199913 | Xueqiang3513@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Xue | Yan'an Affiliated Hospital of Kunming Medical University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Usual Care | Diagnostic Test | Participants randomized to usual care will be evaluated according to institutional standard practice. |
|
| 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. | 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 | 6-month, 12-month |
| Seattle Angina Questionnaire | angina status, will be assessed using the Seattle Angina Questionnaire | 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. | 6-month, 12-month |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |