Safety and Efficacy of DCB Therapy for ISR Under the Guidance of QFR (UNIQUE-DCB-II Study )
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary Heart Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
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 QFR compared with DES implantation. Based on previous study reported, the incidence rate of target le...
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 QFR compared with DES implantation. Based on previous study reported, the incidence rate of target lesion failure is about 3% in patients with ISR undergoing DES implantation. And the design of non-inferiority study was performed in our study. Moreover, the investigators estimated 10% loss follow-up of these patients in each arm. As a result, a total of 220 patients with ISR were required, and with 110 patients per group as a ratio of 1:1 randomization.
Tracking Information
- NCT #
- NCT04119986
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Fei Ye, MD Nanjing First Hospital, Nanjing Medical University
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