Hong Kong-based OrbusNeich has enrolled its first patient in the multinational abluminal sirolimus-coated bio-engineered stent (MASCOT) post-marketing registry.
The company said that the first COMBO Dual Therapy Stent implant was carried out at the Amphia Hospital in Breda, Netherlands.
Approximately 2,500 patients will be enrolled in up to 50 centres across Asia and Europe in a year, in the prospective, multicentre registry, which is claimed to be the largest clinical study of the dual therapy stent to date.
The study is designed to evaluate the long-term safety and effectiveness of the COMBO Stent in routine clinical practice.
The study’s primary endpoint is device-oriented target lesion failure (TLF), defined as the composite of cardiac death, non-fatal heart attack (myocardial infarction or MI) not clearly attributable to a non-target vessel, or target lesion revascularization (TLR) from enrolment to 12 months.
Principal investigator of the study is San Raffaele Hospital professor Antonio Colombo and the director of the clinical coordinating centre is Roxana Mehran from the Mount Sinai Medical Center.
Colombo said: "Long-term safety remains an important area of clinical investigation with stents, particularly the avoidance of neoatherosclerosis and late stent thrombosis.
"The MASCOT registry will provide important information about the unique dual therapy approach of the COMBO Stent, which offers the possibility of functional arterial vessel healing, which we have not seen with any of the monotherapy drug eluting stents."
In addition to the MASCOT registry, the company is supporting the COMBO Stent with other clinical programmes including the REDUCE trial, which enrolled its first patient in June 2014 and aims to show the potential for a shorter period of dual antiplatelet therapy.
OrbusNeich president and chief operating officer Wayne Johnson said: "The initiation of MASCOT, our largest registry trial to date, represents the commitment we have made to really understand the patient benefits of the COMBO Stent.
"Only by delivering true vessel healing can patients feel safe for the long term. We expect the MASCOT trial to confirm what we have already seen with the COMBO Stent as it relates to vessel healing."
The COMBO Dual Therapy Stent helps in accelerating both endothelial coverage, as well as control neo-intimal proliferation through the combination of the Pro-Healing Technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that is completely dissipated within 90 days.