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Drug-Coated Balloon

Paclitaxel Coated Balloon 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

Target lesion is located within a saphenous vein or arterial graft.

Target lesion length must be < 26 mm (by visual estimate) and must be covered by only one balloon.

Must not have

Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent).

STEMI or QWMI <72h prior to the index procedure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether the Agent Paclitaxel Coated PTCA Balloon Catheter is safe and effective in treating patients with in-stent restenosis.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include reactions at the catheter insertion site such as bleeding or bruising, artery re-narrowing or blockage post-treatment, allergic reactions to paclitaxel coating on the device used during treatment.

Eligibility Criteria

Inclusion Criteria

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

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My target lesion is in a vein or artery graft.

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

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I am 18 years old or older.

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My heart stent has narrowed again in a blood vessel that is 2.0 to 4.0 mm wide.

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My target lesion has been successfully widened.

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My treatment targets a lesion at a vessel branching point.

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I have a significant blockage in the main artery of my heart.

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My heart's artery blockage is more than 50% but not completely blocked.

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I have a significant narrowing in another artery near my heart.

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I am eligible for a procedure to open blocked arteries in my heart.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe kidney problems or am on dialysis.

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

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I have a serious illness that may shorten my life to under 2 years.

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I cannot tolerate blood-thinning medications needed for a procedure.

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I am allergic to paclitaxel or similar medications.

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I have a severe heart condition requiring medication or devices to maintain blood pressure.

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I had a heart procedure within the last month.

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I am scheduled for a heart procedure after my initial treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Target Lesion Failure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AGENT DCBExperimental Treatment1 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 CatheterActive Control1 Intervention

0 / 18Eligibility criteria met