Prevail DCB for Coronary Artery Disease
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.12345Why 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.12346
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo percutaneous coronary intervention using the Prevail Drug-Coated Balloon for either ISR or de novo lesions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prevail DCB
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Vascular
Lead Sponsor
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
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.
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.
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-RegistryMedtronic Prevailâ„¢ 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 ...
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 ...
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 ...
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