← Back to Search

Anti-metabolites

AGENT DCB 40 mm for Stent Restenosis (AGENT IDE Trial)

Phase 3
Waitlist Available
Led By Robert Yeh, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Subject must be at least 18 years of age
* Subject (or legal guardian) understands the trial requirements and the treatment procedures, and provides written informed consent before any trial-specific tests or procedures are performed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month
Awards & highlights

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.

Who is the study for?
This trial is for patients who have had a previous stent placed in their heart's arteries and are now experiencing re-narrowing within the same spot. The affected artery must be between 2.0 mm to 4.0 mm wide, and the blockage up to 36 mm long.
What is being tested?
The study is testing a special drug-coated balloon catheter called AGENT DCB 40 mm, designed to treat narrowed areas inside previously placed stents in heart arteries without needing another stent.
What are the potential side effects?
Possible side effects may include bleeding at the catheter insertion site, blood vessel damage, allergic reactions to the drug on the balloon, or re-blockage of the artery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Target Lesion Failure

Trial Design

1Treatment groups
Experimental Treatment
Group I: AGENT DCB 40 mmExperimental Treatment1 Intervention
Agent DCB 40 mm is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391).

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
735 Previous Clinical Trials
937,792 Total Patients Enrolled
Robert Yeh, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
600 Total Patients Enrolled
~13 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top