REVA Medical has begun patient enrolment in Europe for the ReZolve™ sirolimus-eluting bioresorbable coronary scaffold RESTORE pilot study in addition to its primary site in Sao Paulo, Brazil.
ReZolve scaffold integrates the company’s scaffold design with a polymer to provide full X-ray visibility, clinically relevant sizing and a controlled and safe resorption rate.
The prospective multi-centre RESTORE trial will determine the safety and performance of the ReZolve scaffold in 50 patients with symptomatic coronary artery disease at multiple centres in Brazil and Europe.
The primary endpoint of the trial is freedom from symptomatic target lesion revascularisation (retreatment) at a six-month clinical evaluation, followed by imaging of the stented area at 12 months.
In the trial, patients will be followed for five years, examining overall major adverse coronary events (MACE) including myocardial infarction and death.
ReZolve scaffold may minimise the incidence of late forming blood clots, or thrombosis, generally associated with currently available drug-eluting metal stents.
The first patient implantation in Europe was performed at the Klinikum Coburg in Coburg, Germany.
Klinikum Coburg professor Johannes Brachmann said, "The implantation of the ReZolve scaffold resulted in excellent restoration of full blood flow through the artery."
"We are looking forward to enrolling additional patients in the trial at our hospital here in Coburg," Brachmann added.
The RESTORE study data will become available throughout this year as patients pass the one- and six-month clinical evaluation stages, the company said.
The company is also planning to commence a larger clinical trial in Brazil, Europe, Australia and New Zealand, that is anticipated to provide the data needed to apply for CE Mark approval in Europe.
Based in Delaware, US, REVA is a development stage medical device company specialised in the development of proprietary, bioresorbable stent products.