Enrollment Reaches 110 Patients In Investigator Initiated, Randomized Trial Of OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM)

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Medical Devices
Article Date: 18 Oct 2007 - 0:00 PDT

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Enrollment in the randomized TRIAS (TRI-stent Adjudication Study) trial of OrbusNeich's Genous Bio-engineered R stent has reached 110 patients since the initiation of the trial in April, according to Robbert de Winter, M.D., Ph.D., principal investigator and director of the catheterization laboratory at the Academic Medical Center in Amsterdam.

The trial involves approximately 50 centers throughout Europe and consists of high risk of restenosis (HR) and low risk of restenosis (LR) arms. In the TRIAS HR arm, approximately 1,250 patients will be enrolled for a non-inferiority study of Genous vs. Taxus or Cypher drug-eluting stents. In the TRIAS LR arm, approximately 1,250 patients will be enrolled for a superiority study of Genous vs. bare metal stents. The primary endpoint in both arms is target vessel failure within 12 months with clinical follow-up extending to five years.

"With the interventional cardiology community's concerns with the long- term safety of drug-eluting stents, we must look to new technologies that are as effective in terms of restenosis while minimizing the concern about long- term thrombosis," said de Winter. "The dual antiplatelet therapy requirement for Genous is only 30 days. Drug-eluting stents require a minimum of six months of dual antiplatelet therapy, which gives rise to many patient compliance and cost issues."

All TRIAS participants will receive one week of statin therapy pre- procedure. Patients treated with a Genous or bare metal stent will receive 30 days of clopidogrel post-procedure, while patients treated with a Taxus or Cypher stent will receive at least six months of clopidogrel post-procedure.

For TRIAS, high risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than 2.8 mm) and/or long lesions (greater than 20 mm). Target vessel failure is defined as cardiac death, myocardial infarction or repeat vascularization of a treated vessel.

Genous is coated with an antibody to capture a patient's endothelial progenitor cells, and, therefore, accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of the Genous stent, EPCs can form an endothelial layer over the stent to provide protection against thrombus and minimize restenosis. The stent was developed by OrbusNeich, a global medical device company.

Academic Medical Center
http://www.OrbusNeich.com