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)

NCT06492174 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Boston Scientific Corporation
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	20
Start date	2024-10-07
Completion	2027-12

Conditions

• In-Stent Restenosis

Interventions

• AGENT DCB 40 mm

Primary outcomes

• Number of Participants With Target Lesion Failure — 12-month
  The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, 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

Countries

United States