Medtronic's Prevail DCB Receives FDA IDE Approval for Pivotal Clinical Trial
核心洞察
Medtronic has secured FDA IDE approval to initiate a pivotal clinical trial for its Prevail drug-coated balloon (DCB).
The trial will evaluate the Prevail DCB (搜索) for treating in-stent restenosis (搜索) (ISR) and de novo small vessel disease.
The study will enroll 1,205 patients across the US, Europe, and Asia Pacific, with a primary endpoint of target lesion failure at 12 months.
Medtronic has received FDA investigational device exemption (IDE) approval to begin a pivotal clinical trial for its Prevail coronary paclitaxel drug-coated balloon (DCB). The trial will assess the device's effectiveness in treating in-stent restenosis (搜索) (ISR) and de novo small vessel disease. The dual cohort, international, multi-center clinical trial plans to enroll up to 1,205 subjects with coronary artery disease (搜索) from approximately 65 centers across the US, Europe, and Asia Pacific.
Trial Design and Objectives
The Prevail Global Clinical Program aims to gather data supporting the product’s approval in the US and Japan. The trial includes a randomized controlled ISR patient evaluation and a single-arm assessment of de novo small vessel disease patients to determine the efficacy and safety of the Prevail DCB (搜索).
Study Leadership and Cohort Details
Dr. David Kandzari and Professor Bruno Scheller from Saarland University, Germany, will lead the ISR Cohort. This cohort will compare the Medtronic Prevail DCB (搜索) with Boston Scientific’s AGENT DCB (搜索) in a 1:1 ratio to evaluate non-inferiority. Azeem Latib, system director of Interventional Cardiology at Montefiore Health System, and Darren Mylotte, consultant cardiologist at Galway University Hospital, will oversee the DNSV Cohort. This cohort will compare the Prevail DCB against drug-eluting stents using historical control data from the Resolute Onyx Clinical Program.
Endpoints and Follow-Up
For both cohorts, the primary endpoint will be target lesion failure (TLF) at 12 months, with patient follow-up extending to five years. Target lesion failure is a composite endpoint that typically includes cardiac death, target vessel myocardial infarction, and target lesion revascularization.
Clinical Significance
According to Prevail Global Study co-principal investigator David Kandzari, drug-coated balloons provide clinicians with an anti-restenosis solution without the need for a permanent stent, which is particularly important as physicians treat more patients with complex lesions. The Prevail DCB (搜索) is designed for use during percutaneous coronary intervention procedures to treat narrowed or blocked arteries in patients with coronary artery disease (搜索). During this procedure, the balloon inflates within the artery while delivering the paclitaxel drug to the arterial tissue, where it is absorbed to provide a lasting anti-restenotic effect. The global study builds on experience with Prevail DCB usage worldwide.