Paclitaxel-Coated Balloon Catheter for Stent Restenosis

(AGENT IDE Trial)

Recruiting at 25 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you should discuss your current medications with the trial team, especially if you have allergies or intolerances to antiplatelet drugs, anticoagulants, or contrast dye.

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, you should not have an intolerance to antiplatelet drugs or anticoagulants, as these are required for the procedure.

What data supports the idea that Paclitaxel-Coated Balloon Catheter for Stent Restenosis is an effective treatment?

The available research shows that Paclitaxel-Coated Balloon Catheters are effective in reducing the risk of restenosis, which is the re-narrowing of blood vessels, after procedures to open blocked arteries. For example, one study compared a novel paclitaxel-coated balloon with a regular balloon and found that the paclitaxel-coated balloon was more effective in treating peripheral artery disease. Another study highlighted that these balloons are used successfully in different types of coronary lesions, indicating their versatility and effectiveness. While some studies focus on peripheral artery disease, the positive outcomes suggest that the treatment is promising for stent restenosis as well. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Paclitaxel-Coated Balloon Catheter for Stent Restenosis?

Research shows that paclitaxel-coated balloon catheters can help prevent restenosis (re-narrowing of blood vessels) after procedures to open blocked arteries, both in the heart and in peripheral arteries. This suggests that the treatment may be effective in reducing the risk of stent restenosis. ^{1 2 3 4 5}

What safety data is available for the Paclitaxel-Coated Balloon Catheter?

The safety data for the Paclitaxel-Coated Balloon Catheter, also known as the Agent DCB, is limited but includes real-world multicenter experiences and registry data. Studies have assessed its safety and efficacy in percutaneous coronary interventions and compared it to other treatments like plain old balloon angioplasty. However, there is conflicting evidence about the risk of mortality associated with paclitaxel-coated balloons, and the effectiveness varies depending on the type of lesion and the specific DCB used. ^{1 2 4 5 6}

Is the Paclitaxel-Coated Balloon Catheter generally safe for humans?

The safety of paclitaxel-coated balloons, including the Agent Paclitaxel-Coated Balloon Catheter, has been evaluated in various studies. While they are used to reduce the risk of restenosis (re-narrowing of blood vessels) in different conditions, there is conflicting evidence about the risk of mortality, indicating that safety may vary depending on the specific type and use. ^{1 2 4 5 6}

Is the Paclitaxel-Coated Balloon Catheter a promising treatment for stent restenosis?

Yes, the Paclitaxel-Coated Balloon Catheter is a promising treatment because it helps reduce the risk of restenosis, which is when a blood vessel narrows again after treatment. Studies show it can be effective in different types of blood vessel blockages and is being tested for its safety and effectiveness in real-world settings. ^{1 2 3 4 5}

How is the Agent Paclitaxel-Coated Balloon Catheter treatment different from other treatments for stent restenosis?

The Agent Paclitaxel-Coated Balloon Catheter is unique because it uses a drug-coated balloon with paclitaxel, which is designed to prevent the re-narrowing of arteries by delivering the drug directly to the artery walls during the procedure, unlike traditional treatments that may not have this targeted drug delivery feature. ^{1 2 3 4 5}

Research Team

Robert Yeh, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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.

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 less than or equal to 36 mm and can be covered by one balloon.

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

Exclusion Criteria

I am not pregnant or nursing.

I do not have a serious illness that could shorten my life to under 2 years.

Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.)

Timeline

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 for in-stent restenosis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits as per protocol

Treatment Details

Interventions

• Agent Paclitaxel Coated PTCA Balloon Catheter

Trial Overview 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.

Participant Groups

Group I: AGENT DCB 40 mm Experimental Treatment 1 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).

Agent Paclitaxel Coated PTCA Balloon Catheter is already approved in United States for the following indications:

Approved in United States as Agent DCB for:

• Treatment of in-stent restenosis (ISR) in native coronary arteries

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

Findings from Research

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]

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]

In a study involving 14 patients undergoing peripheral angioplasty with paclitaxel-coated balloons, the procedure was successful and showed no systemic side effects from the drug, as paclitaxel plasma levels remained below harmful thresholds.

Paclitaxel levels peaked at 40 ng/ml immediately after the procedure but dropped to undetectable levels within 24 hours, indicating that the use of these coated balloons is safe and effective for preventing restenosis without significant systemic exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma levels following application of paclitaxel-coated balloon catheters in patients with stenotic or occluded femoropopliteal arteries. Freyhardt, P., Zeller, T., Kröncke, TJ., et al.[2015]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Coronary Intervention With the Agent Paclitaxel-Coated Balloon: A Real-World Multicenter Experience. [2021]

2. France 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. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Plasma levels following application of paclitaxel-coated balloon catheters in patients with stenotic or occluded femoropopliteal arteries. [2015]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions. [2021]

6. United States 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. [2019]