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This is a prospective single center, randomized controlled clinical study aimed to compare the clinical and angiographic follow-up results of patients with in-stent restenosis(ISR) after coronary drug eluting stent(DES) implantation treated by fractional flow reserve -guided and angiography guided drug eluting balloon(DEB) intervention. This study intends to confirm the clinical benefits of optimizing DEB intervention of DES-ISR by FFR.
420 patients with DES-ISR will be recruited in this study. After angiography, patients with DES-ISR to be treated with DEB will be randomly assigned to FFR-guided and angiography-guided groups. In FFR group, FFR at maximum hyperemia will be measured after pretreatment of DES-ISR lesion by balloons(non-compliant balloon, cutting balloon or scoring balloon). If FFR <0.9, the operator will dilate the DES-ISR lesion again before another FFR is measured. If FFR>=0.9, DEB will be used and final FFR will be measured at the end of the procedure. In angiography group, the operator will treat the DES-ISR lesion with balloons(non-compliant balloon, cutting balloon or scoring balloon), and then DEB without FFR guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR | In FFR group, FFR at maximum hyperemia will be measured after pretreatment of DES-ISR lesion by balloons(non-compliant balloon, cutting balloon or scoring balloon). If FFR <0.9, the operator will dilate the DES-ISR lesion again before another FFR is measured. If FFR>=0.9, DEB will be used and final FFR will be measured at the end of the procedure. |
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| CAG | In angiography group, the operator will treat the DES-ISR lesion with balloons(non-compliant balloon, cutting balloon or scoring balloon), and then DEB without FFR guidance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fractional flow reserve | Device | FFR is a physiological functional parameter indicating the severity of ischemic myocardium perfused by a diseased coronary artery. It is measured by a pressure wire placed in the coronary artery and calculated by the ratio of pressures distal and proximal to the stenosis. |
| Measure | Description | Time Frame |
|---|---|---|
| target vessel failure | cardiac death, target vessel myocardial infarction, target vessel failure | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| angiographic outcomes | diameter stenosis, binary stenosis and late lumen loss measured by QCA | 12 month |
| target vessel failure | cardiac death, target vessel myocardial infarction, target vessel failure |
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Inclusion Criteria:
In-stent restenosis(ISR) occurred more than 6 months after drug eluting stent (DES) implantation
Exclusion Criteria:
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patients with coronary artery disease and DES implantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Qin, MD | Contact | 021-64041990 | 5112 | qin.qing@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, MD | Fudan University | Principal Investigator |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 36 month |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |