Status:
UNKNOWN
A Comparison Between FFR Guided and CAG Guided Treatment Using DEB in ISR of DES
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
In Stent Restenosis
Drug Eluting Stent
Eligibility:
All Genders
18-75 years
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...
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...
Eligibility Criteria
Inclusion
- In-stent restenosis(ISR) occurred more than 6 months after drug eluting stent (DES) implantation
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04518826
Start Date
October 1 2020
End Date
October 1 2024
Last Update
August 19 2020
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