Medtronic has received approval of a US Food and Drug Administration (FDA) investigational device exemption (IDE) to initiate its pivotal clinical trial of the Prevail coronary paclitaxel drug-coated balloon (DCB) for in stent restenosis (ISR) and de novo small vessel disease.
Data from the Prevail Global Clinical Program will be used to support approval of the Prevail DCB in Japan and the USA.
The multicentre, dual cohort clinical trial will enrol up to 1,205 patients with coronary artery disease from approximately 65 global centres across the USA, Europe and Asia Pacific.
The trial will include a randomised controlled evaluation of ISR patients and a single arm evaluation of de novo small vessel disease patients to assess the safety and efficacy of the Prevail DCB.
“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,” said David Kandzari (Piedmont Heart Institute and Cardiovascular Services, Atlanta, USA), co-principal investigator of the Prevail Global Study. “Drug-coated balloons provide clinicians with an anti-restenosis solution, without the need of a permanent stent. This groundbreaking trial will include the first head-to-head randomised trial of two drug coated balloons in the USA and will provide important additional evidence for this growing therapy.”
The ISR Cohort will be led by Kandzari and Bruno Scheller (Saarland University, Homburg, Germany) and will randomise patients 1:1 with the Medtronic Prevail DCB and Boston Scientific Agent DCB to assess non-inferiority.
The de novo small vessel (DNSV) cohort will be led by Azeem Latib (Montefiore Health System, New York, USA) and Darren Mylotte (Galway University Hospital, Galway, Ireland) and will compare Prevail DCB against drug-eluting stents, the standard of care for small vessel treatment, using a historical control from the extensive body of evidence from the Resolute Onyx Clinical Program. The primary endpoint for both cohorts will be target lesion failure (TLF) at 12 months. Patients will be followed out to five years.
“The launch of the Prevail IDE study underscores our commitment to pioneering advanced solutions for complex PCI,” stated Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. “The Prevail DCB has the potential to be a significant advancement in the coronary market. Medtronic is proud to invest in the expansion of clinical evidence to bring Prevail to patients globally. As a leader in drug and device combination therapies for vascular diseases, we look forward to collaborating closely with study investigators and the FDA to initiate patient enrolment in the forthcoming months.”
The Prevail Global Study will build upon the experience from the use of Prevail DCB globally. Prevail DCB was launched in Europe in 2021 with indications for the treatment of de novo lesions, in-stent restenosis, and small vessel disease in the coronary arteries.
The Prevail DCB is commercially available in more than 79 countries globally. Within the Prevail Global Study, Prevail DCB is investigational. Prevail DCB is not approved or sold in the USA or Japan.
