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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

Study testing a balloon catheter for artery narrowing treatments.

Recruiting
18 years and older
All
Phase 3
The **AGENT IDE study** tests a special balloon called the Agent Paclitaxel Coated PTCA Balloon Catheter. This balloon helps treat **in-stent restenosis (ISR)**, which is when a previously treated artery gets narrow again. The study focuses on lesions (damaged areas) in coronary arteries, which supply blood to the heart, that are between 26 mm and 36 mm long. The study compares this new balloon with traditional balloon angioplasty, a common method to widen arteries. To join, you must be 18 or older, willing to follow up for a year, and able to have a **percutaneous coronary intervention (PCI)**, a procedure that uses a balloon to open arteries. Women who can become pregnant should use birth control for a year after the procedure. Exclusions include serious illnesses, substance abuse, and recent heart procedures. **Key Points**: - **Study Length**: Follow-up required for 12 months. - **Visits Needed**: Multiple visits for monitoring and evaluations. - **Risks**: Potential risks include usual procedural risks and reactions to the balloon's coating. Before participating, discuss any medical conditions or concerns with your doctor to ensure safety and eligibility.
Study details
    In-Stent Restenosis

NCT06492174

Boston Scientific Corporation

4 January 2025

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