NCT04058990

Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)

A 2:1 Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.

Detailed 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 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Device: Paclitaxel-Coated PTCA Balloon Catheter	Percutaneous Transluminal Coronary Angioplasty
DEVICE	SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel	Percutaneous Transluminal Coronary Angioplasty

Timeline

• Start date: 2019-12-12
• Primary completion: 2021-12-22
• Completion: 2026-06-30
• First posted: 2019-08-16
• Last updated: 2026-04-13
• Results posted: 2022-12-23

Locations

14 sites across 1 country: Japan

Regulatory

• FDA-regulated device study