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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    180
  • sponsor
    Boston Scientific Corporation
Updated on 20 June 2021
Investigator
Sachiyo Sato
Primary Contact
Kyoto-Katsura Hospital (5.1 mi away) Contact
+13 other location
stenosis
paclitaxel
angina pectoris
unstable angina
percutaneous coronary intervention
ischemia
stable angina
bypass graft
coronary angioplasty
in stent restenosis

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.

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.

Details
Condition Coronary Artery Disease, Coronary heart disease, Cardiac Ischemia, Myocardial Ischemia
Treatment Device: Paclitaxel-Coated PTCA Balloon Catheter, SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
Clinical Study IdentifierNCT04058990
SponsorBoston Scientific Corporation
Last Modified on20 June 2021

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