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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04518826
Other study ID # FFRCAG
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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