Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 150
Summary
- Conditions
- Coronary (Artery) Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: SV study: A prospective, multicenter, 2:1 randomized, controlled, single-blind, non-inferiority trial.150 subjects are expected to be enrolled to support a 2:1 randomization. (Investigational test device: Agent DCB, N=100 subjects or Control device: SeQuent Please DCB, N=50 subjects) ISR substudy: A prospective, multicenter, single-arm, open-label trial. 30 subjects are expected to be enrolled.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
Description
Primary objective is to evaluate the safety and effectiveness of the Agent ™ Paclitaxel-Coated PTCA Balloon Catheter for the treatment of Japanese subjects with a small vessel de novo native atherosclerotic coronary artery lesion or in-stent restenosis (ISR) of a previously treated lesion. Primary e...
Primary objective is to evaluate the safety and effectiveness of the Agent ™ Paclitaxel-Coated PTCA Balloon Catheter for the treatment of Japanese subjects with a small vessel de novo native atherosclerotic coronary artery lesion or in-stent restenosis (ISR) of a previously treated lesion. Primary endpoint: Target Lesion Failure (TLF) rate at 6 months post index-procedure. TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Tracking Information
- NCT #
- NCT04058990
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Masato Nakamura, MD Toho University Ohashi Medical Center
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