Paclitaxel Coated Balloon for Stent Restenosis

(AGENT IDE Trial)

Recruiting in Palo Alto (17 mi)

+39 other locations

Overseen by Robert Yeh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Boston Scientific Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Robert Yeh, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for adults with in-stent restenosis, a condition where arteries narrow after stent placement. Participants must have a lesion treatable by one balloon and agree to contraception if applicable. Exclusions include recent heart procedures, severe heart or kidney issues, COVID-19 within 4 weeks, pregnancy, certain blood disorders, drug abuse, and allergies to trial materials.

Inclusion Criteria

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

My target lesion is in a vein or artery graft.

My target lesion is smaller than 26 mm and can be covered by one balloon.

Exclusion Criteria

I have severe kidney problems or am on dialysis.

I had a severe heart attack less than 72 hours ago.

I have had COVID-19 recently or am currently infected but my symptoms have resolved.

Treatment Details

Interventions

• AGENT DCB (Drug-Coated Balloon)
• PTCA balloon catheter (Procedure)

Trial Overview The study compares the Agent Paclitaxel Coated PTCA Balloon Catheter against standard balloon angioplasty for treating narrowed arteries due to previous stents. It's randomized (2:1) across multiple centers with participants having lesions up to 26 mm long in coronary arteries sized 2.0-4.0 mm.

Participant Groups

Group I: AGENT DCB Experimental Treatment 1 Intervention

Agent DCB 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).

Group II: Commercially available, PTCA Dilation Catheter Active Control 1 Intervention

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology