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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04518826
• Other study ID #: FFRCAG
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: August 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Qing Qin, MD
• Phone: 021-64041990
• Email: qin.qing[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Drug Eluting Stent
• In Stent Restenosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target vessel failure	cardiac death, target vessel myocardial infarction, target vessel failure	12 month
Secondary	angiographic outcomes	diameter stenosis, binary stenosis and late lumen loss measured by QCA	12 month
Secondary	target vessel failure	cardiac death, target vessel myocardial infarction, target vessel failure	36 month