A Comparison Between FFR Guided and CAG Guided Treatment Using DEB in ISR of DES

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparison Between Fractional Flow Reserve Guided and Coronary Angiography Guided Treatment Using Drug Eluting Balloon in In-stent Restenosis of Drug Eluting Stent: a Single-center, Prospective, Randomized Controlled Clinical Trial

Conditions
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In Stent Restenosis, Drug Eluting Stent, Coronary Artery Disease

Intervention / Treatment
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* Device: fractional flow reserve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In-stent restenosis(ISR) occurred more than 6 months after drug eluting stent (DES) implantation Exclusion Criteria: ISR in bare metal stents and biodegradable stents Complicated with immune diseases ISR in left main DES Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment Severe cardiac insufficiency (LVEF <30%) Subjects with ST segment elevation myocardial infarction within 7 days of onset of chest pain Pregnant or lactating women Combined with other diseases, life expectancy <1 year Follow - up visits required by the protocol cannot be followed, or the investigators believe that the participation of subjects in the trial will increase the risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FFR<br>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. | Device: fractional flow reserve<br>* 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.<br>|
| CAG<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target vessel failure | cardiac death, target vessel myocardial infarction, target vessel failure | 12 month | 

Secondary Outcome Measures

| Outcome Measure | 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 | 36 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractional flow reserve, in stent restenosis, drug eluting stent