Prevail DCB for Coronary Artery Disease

Recruiting at 44 trial locations

Overseen By Jeroen Frijhoff

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Vascular

Must be taking: Antiplatelets

Must not be taking: Paclitaxel

Disqualifiers: Renal insufficiency, Stroke, Acute MI, others

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

Compensation: Varies

Number of Visits: 31

Duration: Hospital stay

1205 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Prevail DCB, a new treatment for heart conditions related to blocked arteries. It consists of two parts: one for individuals with previously stented arteries and another for those with small vessel disease (narrow arteries). Candidates may qualify if they have stable or unstable angina (chest pain from heart issues) or a history of non-severe heart attack.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, if you have a known sensitivity to certain medications like paclitaxel or antiplatelet drugs, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Prevail DCB, a drug-coated balloon, demonstrates promising safety results from past studies. For individuals with in-stent restenosis (ISR), where a stent narrows again, the Prevail DCB resulted in lower death rates one and two years post-procedure. Specifically, only 4.7% of patients experienced serious issues at one year, and 7.2% at two years.

In cases of small vessel disease, where arteries are very narrow, the Prevail DCB was tested against other common treatments. It proved to be safe, with no major safety concerns compared to other drug-coated balloons.

These findings suggest that the Prevail DCB is well-tolerated, with fewer serious side effects than some other options. This makes it a potentially safe choice for patients with certain heart conditions requiring treatment in narrow or re-narrowed arteries. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Prevail Drug-Coated Balloon (DCB) because it offers a unique approach to treating coronary artery disease, especially in challenging cases like in-stent restenosis (ISR) and small vessel disease. Unlike traditional drug-eluting stents (DES) that leave a permanent implant, the Prevail DCB delivers medication directly to the artery wall without leaving anything behind, potentially reducing long-term complications. This method could improve artery healing and decrease re-narrowing rates, offering a promising alternative to current treatments. Additionally, its use in small vessel disease aims to enhance outcomes where other devices often fall short due to size limitations.

What evidence suggests that the Prevail DCB is effective for ISR and small vessel disease?

This trial will evaluate the clinical safety and efficacy of the Prevail Drug-Coated Balloon (DCB) in two separate treatment arms. The ISR Cohort Prevail DCB arm focuses on treating in-stent restenosis (ISR) in coronary lesions previously treated with drug-eluting or bare metal stents. Meanwhile, the DNSV Cohort arm evaluates the Prevail DCB for de novo lesions in small vessel disease, comparing it to a historical control of drug-eluting stents (DES). Research has shown that the Prevail DCB could be a promising treatment for these heart conditions. Previous studies found that the Prevail DCB performed as well as traditional DES and proved even safer for patients with complicated heart problems, achieving a 98.7% success rate in procedures with very few cases of blood clots forming in the treated area. These findings suggest that the Prevail DCB could be a dependable option for treating coronary artery problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Azeem Latib

Principal Investigator

Montefiore Health System

Darren Mylotte

Principal Investigator

Galway University Hospitals

David Kandzari

Principal Investigator

Piedmont Heart Institute

Bruno Scheller

Principal Investigator

University of Saarland

Are You a Good Fit for This Trial?

Inclusion Criteria

I am not pregnant.

I have angina or had a mild heart attack but am stable.

My doctor expects me to live more than a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous coronary intervention using the Prevail Drug-Coated Balloon for either ISR or de novo lesions

Hospital stay

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular visits at 30 days, 6, 12, 24, 36, 48, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Prevail DCB

How Is the Trial Designed?

Group I: ISR Cohort Prevail DCB Experimental Treatment 2 Interventions

To evaluate the clinical safety and efficacy of the Prevail DCB in the treatment of ISR with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.

Group II: DNSV Cohort (RVD 2.0 - 2.75mm) Experimental Treatment 1 Intervention

To evaluate the clinical safety and efficacy of the Prevail DCB as compared to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.

Who Is Running the Clinical Trial?

Medtronic Vascular

Lead Sponsor

Trials

67

Recruited

57,500+

Geoff Martha

Medtronic Vascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Laura Mauri

Medtronic Vascular

Chief Medical Officer since 2022

MD from Harvard Medical School

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2025.09.645

TCT-512 Outcomes of the PREVAIL DCB Study The PREVAIL DCB demonstrated non-inferior efficacy and superior safety compared to traditional DES in patients with complex coronary lesions.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002870325000109

Rationale and design of the prevail global trial program ... The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and de novo small vessel lesions.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39863032/

Rationale and design of the prevail global trial program ... The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and de novo small vessel lesions.

4. news.medtronic.com news.medtronic.com/Medtronic-Prevail-TM-paclitaxel-coated-balloon-catheter-shows-positive-performance-in-Swedish-Coronary-Angiography-and-Angioplasty-Registry

Medtronic Prevail™ paclitaxel-coated balloon catheter ... Additionally, the outcomes showed a 98.7% procedure success rate with the Prevail DCB and very low rates of target lesion thrombosis (0.8% at ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06535854

Study Details | NCT06535854 | Prevail Global Study To evaluate the clinical safety and efficacy of the Prevail DCB in the treatment of ISR with coronary lesions previously treated with drug-eluting or bare metal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05562089

Study Details | NCT05562089 | Prevail Drug Balloon Study The primary procedural outcomes are device success which defined as achieving less than 50% residual stenosis after the usage of only the study device, the ...