Your session is about to expire
← Back to Search
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month
Awards & highlights
AGENT IDE 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.Check my eligibility
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.See study design
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.
AGENT IDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My target lesion is in a vein or artery graft.
Select...
My target lesion is smaller than 26 mm and can be covered by one balloon.
Select...
I am 18 years old or older.
Select...
My heart stent has narrowed again in a blood vessel that is 2.0 to 4.0 mm wide.
Select...
My target lesion has been successfully widened.
Select...
My treatment targets a lesion at a vessel branching point.
Select...
I have a significant blockage in the main artery of my heart.
Select...
My heart's artery blockage is more than 50% but not completely blocked.
Select...
I have a significant narrowing in another artery near my heart.
Select...
I am eligible for a procedure to open blocked arteries in my heart.
AGENT IDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Target Lesion Failure Rate
AGENT IDE 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
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
718 Previous Clinical Trials
932,348 Total Patients Enrolled
Robert Yeh, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe kidney problems or am on dialysis.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.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.I have a serious illness that may shorten my life to under 2 years.I have no upcoming procedures that would interfere with the study.I am 18 years old or older.My heart artery was successfully widened or treated without major issues.My heart stent has narrowed again in a blood vessel that is 2.0 to 4.0 mm wide.My target lesion has been successfully widened.I cannot tolerate blood-thinning medications needed for a procedure.I am allergic to paclitaxel or similar medications.My treatment targets a lesion at a vessel branching point.My non-target lesion was treated successfully, with less than 30% blockage and normal blood flow.I have a significant blockage in the main artery of my heart.My heart's artery blockage is more than 50% but not completely blocked.I am not pregnant or nursing, confirmed by a recent test.I have a severe heart condition requiring medication or devices to maintain blood pressure.You are currently struggling with addiction to drugs or alcohol.I have a significant narrowing in another artery near my heart.Any non-target lesion I had was treated successfully before.I had a heart procedure within the last month.I am eligible for a procedure to open blocked arteries in my heart.You are currently participating in another study for an experimental drug or device that hasn't finished yet.I am scheduled for a heart procedure after my initial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: AGENT DCB
- Group 2: Commercially available, PTCA Dilation Catheter
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many different staff members are responsible for this clinical trial?
"This study is based in Beth Israel Deaconess Medical Center in Atlanta, Georgia, Emory University Hospital in Marietta, California, and Wellstar Kennestone Hospital in La Jolla, Missouri. There are also 39 other active sites."
Answered by AI
Does AGENT DCB put individuals at high risk?
"AGENT DCB has received a safety score of 3 from our team at Power. This is due to the fact that Phase 3 trials have data supporting both efficacy and safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger