Medtronic has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a pivotal clinical trial for its Prevail coronary paclitaxel drug-coated balloon (DCB).
This trial is aimed at treating in-stent restenosis (ISR) and de novo small vessel disease.
The Prevail Global Clinical Program data will support the product's approval in the US and Japan.
The dual cohort, international, multi-centre clinical trial will enrol up to 1,205 subjects with coronary artery disease from around 65 centres across the US, Europe, and Asia Pacific.
It will include a randomised controlled ISR patient evaluation and a single-arm assessment of de novo small vessel disease patients for determining the efficacy and safety of the Prevail DCB.
Dr Kandzari and clinical and experimental interventional cardiology professor Bruno Scheller at Saarland University, Germany will lead the ISR Cohort.
This cohort will compare the Medtronic Prevail DCB with Boston Scientific AGENT DCB in a 1:1 ratio to evaluate non-inferiority.
The DNSV Cohort will be overseen by Azeem Latib, system director of Interventional Cardiology at Montefiore Health System; and Darren Mylotte, consultant cardiologist at Galway University Hospital.
It will compare the Prevail DCB against drug-eluting stents using historical control data from the Resolute Onyx Clinical Program.
For both cohorts, the primary endpoint will be target lesion failure (TLF) at 12 months, with patient follow-up extending to five years.
Prevail Global Study co-principal investigator David Kandzari said: “As physicians treat more patients with complex lesions, it is important to have a device that helps to maintain durable patency while preserving future treatment options.
“Drug-coated balloons provide clinicians with an anti-restenosis solution, without the need of a permanent stent.”
The Prevail DCB is designed for use during percutaneous coronary intervention procedures to treat narrowed or blocked arteries in patients with coronary artery disease.
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.
