Paclitaxel Coated Balloon for Stent Restenosis

(AGENT IDE Trial)

Not currently recruiting at 40 trial locations

Overseen By Patricia O'Mara

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boston Scientific Corporation

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Cancer, Heart failure, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat in-stent restenosis, a condition where a previously treated artery narrows again. It compares a paclitaxel-coated balloon (a medication-coated tool used to widen arteries) to a regular balloon treatment. The researchers aim to determine if the paclitaxel-coated balloon, known as AGENT DCB, is safer and more effective. Individuals who have had a stent placed in their heart artery and are experiencing narrowing again might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

What prior data suggests that the Agent Paclitaxel Coated PTCA Balloon Catheter is safe for treating in-stent restenosis?

Research has shown that the AGENT DCB, a balloon coated with the drug paclitaxel, demonstrates good safety results. In earlier studies, only 17.9% of patients experienced artery narrowing again after one year, compared to 28.7% of those who received a regular balloon treatment.

The paclitaxel coating helps prevent the artery from narrowing again. One study found that the AGENT DCB was more effective for treating arteries that narrowed again after a stent placement, compared to balloons without the coating.

Overall, this treatment has been well-tolerated, with no major safety concerns reported in these studies. The positive results suggest it could be a safe option for patients with this specific heart issue. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for stent restenosis, such as traditional balloon angioplasty or drug-eluting stents, the AGENT DCB offers a unique approach by using a paclitaxel-coated balloon. This innovative delivery method allows the drug paclitaxel to be directly applied to the artery walls during the angioplasty procedure, potentially reducing the chance of restenosis more effectively. Researchers are excited because this targeted delivery could improve outcomes by ensuring the drug is concentrated precisely where it's needed, potentially leading to better long-term results compared to traditional methods.

What evidence suggests that the Agent Paclitaxel Coated PTCA Balloon Catheter is effective for in-stent restenosis?

Research has shown that the Agent paclitaxel-coated balloon (DCB), which participants in this trial may receive, effectively treats in-stent restenosis (ISR), a condition where a previously treated artery becomes narrow again. Studies have found that this drug-coated balloon better prevents the artery from narrowing compared to a regular balloon. Specifically, the paclitaxel-coated balloon reduces the risk of the artery narrowing again by about 38%. One-year data also supports its safety and effectiveness, particularly in small blood vessels. Overall, the Agent DCB has proven more effective than standard balloon treatments in these situations. ^{2 3 6 7 8}

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Agent Paclitaxel Coated PTCA Balloon Catheter or balloon angioplasty (POBA) for in-stent restenosis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AGENT DCB
• PTCA balloon catheter

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

In a study of 135 patients treated with paclitaxel drug-coated balloons (DCB) for in-stent restenosis (ISR), DCB was found to be significantly less effective for drug-eluting stent (DES) ISR compared to bare metal stent (BMS) ISR, with higher rates of binary restenosis (57% vs. 29%) and target lesion revascularization (TLR) (46% vs. 18%).

The reduced efficacy of DCB treatment was particularly notable in DES-ISR located in degenerated saphenous vein grafts (SVGs), where TLR was required in 72% of cases, compared to only 14% for BMS-ISR, highlighting the challenges of treating DES-ISR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Coated Balloon Is Less Effective for Treatment of DES In-Stent Restenosis Both in Native Coronary Arteries and Saphenous Vein Grafts: Results From a Bicenter Registry. Resch, M., Ostheim, P., Endemann, DH., et al.[2019]

A novel drug-coated balloon (DCB) with 6 μg of paclitaxel (Ptx) per mm² was shown to significantly increase drug concentration in the vessel wall compared to a standard DCB with 3 μg/mm², potentially enhancing its effectiveness in preventing restenosis.

Using a single balloon with 6 μg Ptx/mm² not only doubles the drug delivery compared to the 3 μg/mm² balloons but also simplifies the procedure and may lower healthcare costs by reducing the need for multiple balloons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions. Gemeinhardt, O., Schnorr, B., Speck, U., et al.[2021]

In a multicenter trial involving 171 patients, the novel paclitaxel-coated drug-coated balloon (DCB) significantly reduced late lumen loss by 0.92 mm compared to uncoated balloon angioplasty (POBA) at six months, indicating better efficacy in preventing restenosis.

Patients treated with the DCB showed improved walking ability and a much lower rate of target lesion revascularization (1.3% in the DCB group vs. 18.7% in the POBA group) after 12 months, demonstrating both safety and effectiveness of the DCB in treating peripheral artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial. Teichgräber, U., Lehmann, T., Aschenbach, R., et al.[2020]

The Agent paclitaxel-coated balloon (DCB) demonstrated a high procedural success rate of 92% and a one-year major adverse cardiac event (MACE) rate of 5.7% across 354 patients treated in a real-world registry, indicating its safety and efficacy during percutaneous coronary intervention (PCI).

While the overall MACE rate was low, patients with in-stent restenosis (ISR) experienced a higher rate of 8.3%, suggesting that this group may be at greater risk, which aligns with their more complex clinical profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Coronary Intervention With the Agent Paclitaxel-Coated Balloon: A Real-World Multicenter Experience. Iannopollo, G., Giannini, F., Ponticelli, F., et al.[2021]

Paclitaxel-coated balloons (DCB) significantly increased the risk of needing further procedures to treat the same artery (freedom from target lesion revascularization) compared to plain old balloon angioplasty (POBA), with a risk ratio of 1.24 at 12 months and 1.39 at 24 months based on a meta-analysis of 14 studies involving 2504 patients.

There was also an increased risk of all-cause mortality at 24 months after DCB treatment, with a risk ratio of 1.53, indicating a potential safety concern, although causation was not established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit and risk from paclitaxel-coated balloon angioplasty for the treatment of femoropopliteal artery disease: A systematic review and meta-analysis of randomised controlled trials. Klumb, C., Lehmann, T., Aschenbach, R., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2816073

Paclitaxel-Coated Balloon vs Uncoated ... In this trial, treatment with the paclitaxel-coated balloon lowered the rate of target lesion failure compared with an uncoated balloon, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10764532/

One-year safety and effectiveness of the Agent paclitaxel- ... These data support the safety and effectiveness of the Agent paclitaxel-coated balloon in patients with small vessels and ISR.

3. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2023/10/24/14/45/agent-ide

A Clinical Trial to Assess the Agent Paclitaxel Coated ... The results of this trial indicate that the Agent DCB is superior to conventional balloon angioplasty in reducing target lesion failure at 12 ...

4. news.bostonscientific.com news.bostonscientific.com/2023-10-25-Boston-Scientific-AGENT-TM-Drug-Coated-Balloon-Demonstrates-Superiority-to-Uncoated-Balloon-Angioplasty-in-the-AGENT-IDE-Trial

Boston Scientific AGENT™ Drug-Coated Balloon ... Overall, data demonstrated an approximate 38% relative risk reduction in TLF, and additional 12-month event rates for the AGENT DCB vs. uncoated ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772930324000024

A Comparison of 2 Paclitaxel-Coated Balloon Systems in ... Both paclitaxel DCB systems have similar efficacy and safety outcomes, suggesting that both may be an appropriate treatment choice for patients with de novo ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230035B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The applicant performed a clinical study, AGENT IDE Study, to establish a reasonable assurance of safety and effectiveness of the AGENT ...

7. scai.org scai.org/two-year-outcomes-agent-ide-trial-coverage-crt-2025

Two-Year Outcomes of the AGENT IDE Trial—Coverage ... The AGENT DCB was found to have superior outcomes in treating ISR compared to the uncoated balloon, in line with previous results from the AGENT ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ccd.70082

Real‐World Safety and Complications of the Boston ... The AGENT DCB (Boston Scientific, Marlborough, MA) demonstrated superior efficacy in treating ISR compared to uncoated balloons in randomized ...