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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

Trial ID or NCT#

NCT06492174

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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)

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

Investigator(s)

Jennifer Tremmel
Jennifer Tremmel
Interventional cardiologist, Cardiologist
Susan P. and Riley P. Bechtel Medical Director and Associate Professor of Medicine (Cardiovascular Medicine)

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Contact

Jennifer Tremmel, MD