NCT04647253

A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

Conditions

• In-Stent Restenosis

Interventions

Type	Name	Description
DEVICE	AGENT DCB	Drug coated PTCA balloon catheter
DEVICE	PTCA balloon catheter	PTCA balloon catheter

Timeline

• Start date: 2021-05-11
• Primary completion: 2023-10-02
• Completion: 2027-09-01
• First posted: 2020-11-30
• Last updated: 2026-03-23
• Results posted: 2024-05-31

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated device study