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

NCT04518826 | Unknown

• 1 other identifier: FFRCAG
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

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.

Conditions

In Stent Restenosis; Drug Eluting Stent; Coronary Artery Disease

Keywords

fractional flow reserve; in stent restenosis; drug eluting stent

Outcome Measures

Primary Outcomes (1)

• target vessel failure

  cardiac death, target vessel myocardial infarction, target vessel failure

  12 month

Secondary Outcomes (2)

• angiographic outcomes

  12 month

• target vessel failure

  36 month

Study Arms (2)

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

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.

Interventions

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.

FFR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with coronary artery disease and DES implantation.

You may qualify if:

• In-stent restenosis(ISR) occurred more than 6 months after drug eluting stent (DES) implantation

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Junbo Ge, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Qin, MD

CONTACT

021-64041990; qin.qing@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 19, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2024
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share