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Anti-metabolites

Paclitaxel-Coated Balloon Catheter for Stent Restenosis (AGENT IDE Trial)

Phase 3

Recruiting

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 length must be ≤ 36 mm (by visual estimate) and must be covered by only one balloon

Target lesion must have visually estimated stenosis > 50% and < 100% in symptomatic patients (>70% and <100% in asymptomatic patients) prior to lesion pre-dilation

Must not have

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

Target lesion is located within a saphenous vein or arterial graft

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new medical device called the Agent Paclitaxel Coated PTCA Balloon Catheter in patients who have a blockage in a coronary artery that was previously treated.

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

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My target lesion is less than or equal to 36 mm and can be covered by one balloon.

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

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My target lesion has been successfully pre-dilated.

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I am 18 years old or older.

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

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My heart stent has narrowed again after being treated.

Exclusion Criteria

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

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I have kidney problems with high creatinine or need dialysis.

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My target lesion is in a vein or artery graft.

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I have a blood clot in the vessel being treated.

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I am allergic to paclitaxel or similar medications.

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I cannot tolerate blood thinning medications needed for a procedure.

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I have had 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.

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

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

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

Pivotal Trial

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

No Placebo-Only Group

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

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).

0 / 16Eligibility criteria met