Paclitaxel Coated Balloon for Stent Restenosis
(AGENT IDE Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have an intolerance to antiplatelet drugs or anticoagulants, you may not be eligible to participate.
Is the Paclitaxel Coated Balloon generally safe for humans?
The safety of the Paclitaxel Coated Balloon, including the AGENT DCB, has been studied in various conditions. Some studies suggest it is safe for use in treating coronary and femoropopliteal artery diseases, but there is conflicting evidence about the risk of mortality, indicating the need for careful consideration and consultation with a healthcare provider.12345
How is the Agent DCB drug different from other treatments for stent restenosis?
The Agent DCB is unique because it uses a paclitaxel coating to deliver the drug directly to the vessel wall, which may help prevent the narrowing of the artery after a stent is placed. This method is different from traditional treatments as it combines the mechanical action of a balloon with the targeted drug delivery, potentially reducing the risk of restenosis (re-narrowing of the artery).12367
What data supports the effectiveness of the drug-coated balloon treatment for stent restenosis?
Research shows that paclitaxel-coated balloons can help reduce the risk of restenosis (re-narrowing of blood vessels) after procedures like angioplasty, especially in conditions like femoropopliteal artery disease. However, their effectiveness for drug-eluting stent restenosis in coronary arteries is less clear, with some studies indicating limited benefits.35689
Who Is on the Research Team?
Robert Yeh, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with the Agent Paclitaxel Coated PTCA Balloon Catheter or balloon angioplasty (POBA) for in-stent restenosis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AGENT DCB
- PTCA balloon catheter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
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