Boston Scientific has completed enrolment in the EVOLVE II randomised, controlled clinical trial, designed to further assess the safety and effectiveness of the company’s Synergy stent system.
The company hopes the trial will help achieve regulatory approvals for the treatment of atherosclerotic coronary lesions in the US and Japan.
The CE-marked Synergy stent system features a combination of everolimus drug and an ultra-thin directional polymer coating, which will have its absorption completed after drug elution ends at three months.
The principal investigator of the study Dr Dean Kereiakes said: "I am very pleased that the EVOLVE II trial enrolled so quickly and look forward to the study results for this innovative stent, which was designed for optimal vessel healing."
The EVOLVE II trial began in November 2012 and has now completed enrolment of 1,684 patients at 125 sites worldwide, including the US, Canada, Europe, Australia, New Zealand, Japan and Singapore.
Enrolled patients will be followed for the next five years.
The company recently presented the two-year results of EVOLVE at the EuroPCR Scientific Program in Paris and showed significantly low rates of target lesion revascularisation (1.1%), with no stent thrombosis.
The EVOLVE study was a prospective, randomised, single-blind, first-in-human use report, comparing the Synergy stent system to the Promus element stent system, which uses a durable polymer coating.
Boston Scientific interventional cardiology president Kevin Ballinger said enrolment of EVOLVE II has been completed in just nine months.
"The SYNERGY product underscores our ongoing commitment to delivering meaningful innovation to the interventional cardiology community and reinforces our position as a global leader in medical devices," Ballinger said.
Image: Boston Scientific’s corporate headquarters in Natick, Massachusetts, US. Photo: courtesy of Boston Scientific.