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)

NCT04647253 Phase 3 ACTIVE_NOT_RECRUITING Results posted

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.

Details

Lead sponsor	Boston Scientific Corporation
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	600
Start date	2021-05-11
Completion	2027-09

Conditions

• In-Stent Restenosis

Interventions

• AGENT DCB
• PTCA balloon catheter

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