BD has announced the start of enrolment in a first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB).
The PREVISION trial is a prospective, multicentre, single arm, non-randomised study designed to evaluate the safety of the BD sirolimus DCB in the treatment of peripheral arterial disease (PAD) in the femoropopliteal arteries.
A company press release notes that BD initiated this trial to determine the viability of sirolimus as a future treatment option for patients with PAD. The first patient was successfully treated by principal investigator Andrew Holden at Auckland City Hospital (Auckland, New Zealand).
“It is an honour to enrol the first patient in the PREVISION study,” said Holden. “The burden of PAD continues to impact patients and challenge physicians around the globe. A continued focus on developing next-generation technology is important for the patients suffering from PAD.”
PREVISION is being conducted across multiple sites in Australia, New Zealand, and Singapore. The trial will enrol and follow-up on approximately 50 patients over the coming months.