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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-10-01

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.

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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.

Conditions

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In Stent Restenosis Drug Eluting Stent Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

fractional flow reserve

Intervention Type 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.

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.

No interventions assigned to this group

Interventions

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fractional flow reserve

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.

Intervention Type DEVICE

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

1. ISR in bare metal stents and biodegradable stents
2. Complicated with immune diseases
3. ISR in left main DES
4. Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment
5. Severe cardiac insufficiency (LVEF \<30%)
6. Subjects with ST segment elevation myocardial infarction within 7 days of onset of chest pain
7. Pregnant or lactating women
8. Combined with other diseases, life expectancy \<1 year
9. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No