Status:
NOT_YET_RECRUITING
Safety and Efficacy of DCB Therapy for ISR Under the Guidance of QFR (UNIQUE-DCB-II Study )
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
In 1970, the first percutaneous balloon coronary angioplasty opened a new chapter of interventional therapy. However, the incidence of intracoronary restenosis was about 30%. Subsequently, bare metal ...
Detailed Description
The current study is designed as a multicenter, randomized and prospective study aiming to evaluate the safety and efficacy of drug balloon therapy for ISR in patients with CHD under the guidance of Q...
Eligibility Criteria
Inclusion
- ● Meet the diagnostic criteria for patients with coronary in-stent restenosis and QFR\<0.8 of target lesion in the coronary stent
Exclusion
- QFR less than 0.8, dissection above type B and thrombosis formation after pre-dilation of ISR
- Severe congestive heart failure \[LVEF \<30% or NYHA( New York Heart Association) III/IV)\]
- Severe valvular heart disease
- Life expectancy no more than 1 year or factors causing difficulties in clinical follow up
- Intolerance to aspirin and/or clopidogrel
- Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy
- Leukopenia or thrombopenia
- A history of peptic ulcer or GI bleeding in the previously
- Stroke within 6 months prior to the operation
- A history of severe hepatic or renal failure
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04119986
Start Date
January 1 2026
End Date
December 1 2028
Last Update
May 31 2025
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006