NCT06492174

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

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: 20 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

Detailed description

Please see NCT04647253 for the prospective, randomized, multi-center, single blind trial comparing AGENT DCB to balloon angioplasty (POBA). The Long Lesion Cohort is a non-randomized, single arm cohort of subjects with ISR of a previously treated lesion ≥ 26 mm and ≤ 36 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 40 mm	Drug coated PTCA balloon catheter 40 mm size

Timeline

• Start date: 2024-10-07
• Primary completion: 2025-12-19
• Completion: 2027-12-01
• First posted: 2024-07-09
• Last updated: 2026-03-23

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study