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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04518826

Collaborator

(none)

420

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
In Stent Restenosis Drug Eluting Stent Coronary Artery Disease	Device: fractional flow reserve

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

420 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: 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.
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.

Arm

Intervention/Treatment

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.

Device: 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.

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.

Outcome Measures

Primary Outcome Measures

target vessel failure [12 month]
cardiac death, target vessel myocardial infarction, target vessel failure

Secondary Outcome Measures

angiographic outcomes [12 month]
diameter stenosis, binary stenosis and late lumen loss measured by QCA
target vessel failure [36 month]
cardiac death, target vessel myocardial infarction, target vessel failure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

Principal Investigator: Junbo Ge, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT04518826

Other Study ID Numbers:

FFRCAG

First Posted:

Aug 19, 2020

Last Update Posted:

Aug 19, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Shanghai Zhongshan Hospital

fractional flow reserve

in stent restenosis

drug eluting stent

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Aug 19, 2020