Navigation Links
Enrollment Reaches 110 Patients in Investigator Initiated, Randomized Trial of OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM)
Date:10/17/2007

Multi-Arm, Multi-Center Trial to Compare Genous vs. Drug-Eluting and Bare

Metal Stents

AMSTERDAM, Netherlands, Oct. 17 /PRNewswire/ -- 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.

For more information about TRIAS, call +31.20.56.67.883 or send an e-mail to trias@amc.nl.


'/>"/>
SOURCE Academic Medical Center
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
2. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
3. Celsion Completes Enrollment in Phase I Liver Cancer Study
4. Hematology Analyzers Simple, Sophisticated Technology Serving All Patients
5. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
6. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
7. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
8. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
9. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
10. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
11. TMC125 Showed Significant Virologic Response at Week 24 in Treatment-Experienced HIV Patients With NNRTI Resistance in Phase 3 Trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/24/2016)... NAMUR , Belgium , ...  (NYSE MKT: VNRX), today announced the appointment of ... Board of Directors as a Non-Executive Director, effective ... the Company,s Audit, Compensation and Nominations and Governance ... Board, Dr. Futcher will provide independent expertise and ...
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... payment industry today announced its strategic partnership with Connance, a healthcare industry ... The two companies’ proven, proprietary technology combine to provide health systems, hospitals ...
(Date:6/27/2016)... Park, KS (PRWEB) , ... June 27, 2016 , ... ... in retailers of Eyeglasses . , Millions of individuals in the United States ... eyeglasses have become a way to both correct vision and make a fashion statement. ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... PawPaws ... a new product that was developed to enhance the health of felines. The formula ... , The two main herbs in the PawPaws Cat Kidney Support Supplement ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
Breaking Medicine News(10 mins):