Drug-Coated Balloon for Coronary Artery Disease

Recruiting at 7 trial locations

Overseen By Kim Pena-Trast

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must not be taking: Antiplatelets, Anticoagulants, Paclitaxel

Disqualifiers: Cancer, Heart failure, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

1616 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment option for individuals with coronary artery disease, which affects the heart's blood vessels. The trial tests a special balloon coated with medicine (AGENT Drug-Coated Balloon) to determine if it performs as well as or better than the usual treatment involving a stent or regular balloon. Individuals with a new problem area in their heart's arteries might be suitable candidates for this study. The goal is to determine if the new balloon can safely and effectively treat these heart issues. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

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 Drug-Coated Balloon is safe for treating coronary artery disease?

Studies have shown that the AGENT Drug-Coated Balloon (DCB) is generally safe for treating coronary artery disease. Research indicates that the safety results for the AGENT DCB are acceptable. However, some real-world reports mention issues like the balloon bursting or the shaft breaking, though these problems are uncommon.

The AGENT DCB is the first drug-coated balloon approved in the U.S. for treating in-stent restenosis, which occurs when a previously placed stent becomes narrow again. This approval suggests that the treatment is considered safe for similar conditions.

Overall, while some risks exist, studies and real-world experiences have found the AGENT DCB to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AGENT Drug-Coated Balloon (DCB) because it offers a different approach to treating coronary artery disease compared to traditional treatments like drug-eluting stents and plain old balloon angioplasty (POBA). Unlike standard options that typically release drugs from stents placed in the artery, the AGENT DCB delivers medication directly to the artery wall during the balloon angioplasty procedure, potentially reducing the risk of restenosis (re-narrowing of the artery). This method could improve outcomes for patients with various types of artery lesions, including bifurcations, long lesions, and small vessels, by targeting the artery more precisely and possibly leading to faster recovery times and fewer complications.

What evidence suggests that the AGENT Drug-Coated Balloon could be an effective treatment for coronary artery disease?

Studies have shown that the AGENT Drug-Coated Balloon (DCB) effectively treats coronary artery disease. In this trial, some participants will receive the AGENT DCB, which research indicates can significantly reduce target lesion failure, keeping arteries open better than traditional balloon angioplasty. Data from trials reveal that patients treated with the AGENT DCB experienced fewer adverse events, meaning fewer complications. The AGENT DCB's special coating delivers medication directly to the artery, helping to prevent it from narrowing again. Overall, the AGENT DCB has demonstrated its ability to improve outcomes for people with coronary artery issues. ^{3 4 6 7 8}

Who Is on the Research Team?

David Kandzari

Principal Investigator

Piedmont Heart Institute

Margaret McEntegart

Principal Investigator

NYPH/CUIMC

Are You a Good Fit for This Trial?

This trial is for individuals with new (de novo) coronary lesions who can undergo a heart procedure called PCI. They must understand the study, agree to follow-ups, and use reliable contraception if of child-bearing potential. The lesion should be in a native artery and have certain levels of narrowing.

Inclusion Criteria

My condition requires clinical attention.

I (or my guardian) understand the trial details and have given written consent.

I am willing to follow all the study's required check-ups and procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with AGENT Drug-Coated Balloon or standard of care PCI treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AGENT Drug-Coated Balloon

Trial Overview The AGENT DCB STANCE study compares the safety and effectiveness of using an AGENT Drug-Coated Balloon versus standard care which includes drug eluting stents or balloon angioplasty during PCI on patients with new coronary artery blockages.

How Is the Trial Designed?

Group I: Small Vessel - Test Experimental Treatment 1 Intervention

Small vessel subjects treated with AGENT DCB

Group II: Overall - Test Experimental Treatment 1 Intervention

All subjects treated with AGENT DCB

Group III: Long Lesion - Test Experimental Treatment 1 Intervention

Long lesion subjects treated with AGENT DCB

Group IV: Bifurcation - Test Experimental Treatment 1 Intervention

Bifurcation subjects with side branches treated with AGENT DCB

Group V: Bifurcation - Control Active Control 2 Interventions

Bifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty

Group VI: Small Vessel - Control Active Control 1 Intervention

Small vessel subjects treated with drug eluting stent

Group VII: Overall - Control Active Control 2 Interventions

All subjects treated with standard of care drug eluting stent and/or POBA

Group VIII: Long Lesion - Control Active Control 1 Intervention

Long lesion subjects treated with drug eluting stent

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352407/

Drug-Coated Balloons for Coronary Interventions: A Focused ... The development of catheter-based interventions has revolutionized the treatment of coronary artery disease (CAD), from the first heart ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013302

Drug-Coated Balloons in the Management of Coronary ... Drug-coated balloons (DCBs) are specialized coronary devices comprised of a semicompliant balloon catheter with an engineered coating that allows the delivery ...

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 AGENT IDE trial showed that the Agent DCB is superior to conventional balloon angioplasty in reducing target lesion failure for the treatment of coronary ...

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 ... Data from first coronary DCB study in U.S. meet 12-month primary endpoint, demonstrate low adverse event rates with AGENT DCB.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06959524

AGENT DCB STANCE: Safety and Effectiveness Study of ... AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40778487/

Real-World Safety and Complications of the Boston ... Real-world analysis of FDA MAUDE reports revealed frequent device malfunctions, mainly balloon rupture and shaft breakage, and patient ...

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) safety study using the final AGENT drug coated balloon catheter. The outcomes related to these endpoints were found to be acceptable.

8. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/balloons-catheters-and-guidewires/drug-coated-balloons/agent-drug-coated-balloon/fp00000400.html

AGENT™ Drug-Coated Balloon (DCB) AGENT is the first and only U.S. coronary drug-coated balloon (DCB), introducing a new treatment option for patients with in-stent restenosis (ISR).