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 lon
'/>"/>

SOURCE Academic Medical Center
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

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:8/29/2014)... 29, 2014 /PRNewswire-iReach/ -- ChemImage will present a workshop ... New Zealand Forensic Science Society,s 22 nd ... Adelaide, Australia .  Forensic Scientists will ... that hyperspectral imaging can bring to examination procedures. ... Director of Product Development at ChemImage, will host ...
(Date:8/29/2014)... MENLO PARK, Calif. , Aug. 29, ... (OTCQB: DMPI) ("DelMar" "the Company") today announced the filing ... Company recently changed its fiscal year end to June ... its common stock on a national securities exchange in ... as filed with the United States Securities Exchange Commission ...
(Date:8/28/2014)... 2014 Reportlinker.com announces that a new ... North America Aesthetic Lasers and Energy ... http://www.reportlinker.com/p02343466/North-America-Aesthetic-Lasers-and-Energy-Devices-Market-Outlook-to-2020.html North America Aesthetic ... Summary GlobalData,s new report, "North America ... 2020", provides key market data on the North ...
Breaking Medicine Technology:ChemImage to Discuss Hyperspectral Imaging for Forensic Investigation at the ANZFSS 22nd International Symposium on the Forensic Sciences 2ChemImage to Discuss Hyperspectral Imaging for Forensic Investigation at the ANZFSS 22nd International Symposium on the Forensic Sciences 3DelMar Pharmaceuticals Fiscal 2014 Year End Results and Summary of Recent Developments 2DelMar Pharmaceuticals Fiscal 2014 Year End Results and Summary of Recent Developments 3DelMar Pharmaceuticals Fiscal 2014 Year End Results and Summary of Recent Developments 4DelMar Pharmaceuticals Fiscal 2014 Year End Results and Summary of Recent Developments 5North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 2North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 3North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 4North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 5North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 6North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 7North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 8North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 9North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 10North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 11North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 12North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 13North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 14North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 15North America Aesthetic Lasers and Energy Devices Market Outlook to 2020 16
... The Blumenthal,Cancer Center at Carolinas Medical Center (CMC) ... in a study that could lead to individualized,treatments ... first hospital system,outside Moffitt,s home state of Florida ... CMC will enroll more than 2,300 patients in,the ...
... PCOP ), an innovator in the discovery and ... completion of recruitment,in the company,s multi-center Phase 2a ... product candidate. The objective of the Phase,2a randomized, ... and safety of 200 and 500 mg of ...
Cached Medicine Technology:CMC, Moffitt Partner to Study Cancer 2Pharmacopeia Completes Enrollment in Phase 2 Hypertension Study with PS433540 (DARA) 2Pharmacopeia Completes Enrollment in Phase 2 Hypertension Study with PS433540 (DARA) 3Pharmacopeia Completes Enrollment in Phase 2 Hypertension Study with PS433540 (DARA) 4
(Date:8/30/2014)... After offering hyperbaric oxygen therapy ... past several years, Dr. Roy Schmidt and the ... a scholarship program for veterans who have been ... held this summer to discuss veterans’ needs ( ... shed light on the large number of veterans ...
(Date:8/30/2014)... August 30, 2014 Market Research ... 2009-2019 is a professional and in-depth market survey ... report firstly reviews the basic information of Cell ... The report then explores global and China’s top ... capacity, Production value, and market share etc. The ...
(Date:8/30/2014)... Hundreds of Byetta lawsuits ( http://www.byettalawsuit.com ... forward in U.S. courts, Bernstein Liebhard LLP reports. According ... 31, 2014, Byetta and Bydureon (an extended-release version of ... that allege the drugs caused pancreatitis, pancreatic cancer and ... claims are pending in a multidistrict litigation underway in ...
(Date:8/30/2014)... August 30, 2014 Continuing to meet ... is expanding with the addition of a new doctor ... who has provided leading-edge skin care in Grand Rapids ... , “As a doctor, my passion is making ... partnering with Forefront Dermatology, I’m better able to focus ...
(Date:8/30/2014)... (PRWEB) August 30, 2014 In today’s world, ... difficult to get. Snoring and sleep apnea (a medical problem ... people and their bed partners of the rest they need ... of the population snores and 20 million people in the ... have been diagnosed and treated; and of those treated, many ...
Breaking Medicine News(10 mins):Health News:Tennessee Hyperbaric Center Offering HBOT Scholarships to Veterans 2Health News:Cell Disruptor Industry Global and Chinese Analysis for 2009-2019 in New Research Report at ReportsnReports.com 2Health News:Cell Disruptor Industry Global and Chinese Analysis for 2009-2019 in New Research Report at ReportsnReports.com 3Health News:Cell Disruptor Industry Global and Chinese Analysis for 2009-2019 in New Research Report at ReportsnReports.com 4Health News:Byetta Lawsuits Move Forward, as Bernstein Liebhard LLP Notes Settlements in More than 80 Cases 2Health News:Byetta Lawsuits Move Forward, as Bernstein Liebhard LLP Notes Settlements in More than 80 Cases 3Health News:Expanding Care at the Forefront of Dermatology 2Health News:Snoring: Bad for Relationships, Bad for Health 2Health News:Snoring: Bad for Relationships, Bad for Health 3
... The diagnosis of multiple sclerosis using the magnetic resonance ... the new findings// published by the BMJ. ... the National Institute for Health and Clinical Excellence (NICE) ... sclerosis. Although its accuracy has been assessed, the evidence ...
... ministry have denied the presence of any bird flu infection ... flu,' said Jose Angel del Valle, the ministry's animal health ... in the U.S. commodities markets, leading to a reduction in ... the death of a duck, in the town of Nogales, ...
... government will donate $35,700 to a clinic here ... ,The donation, in Australian dollars, was announced ... ,"The donation again demonstrates the Australian ... she said. ,"By funding this clinic, ...
... of Health in China has revealed that just over 67 ... HIV/AIDS//. ,This survey was conducted recently by a research ... from 1,919 respondents in 24 colleges of 19 cities.,The results ... aware of how HIV/AIDS is transmitted and 75.6 per cent ...
... non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2-selective NSAIDs, ... NEXIUM? (esomeprazole magnesium). // These results were from ... the April 2006 edition of the American Journal ... such as ibuprofen, naproxen and aspirin, and newer ...
... Nitish Kumar is all for a giving a boost to ... tomato and green vegetables// at their official residence, he wants ... farming. ,Nitish Kumar comes from a family with ... practitioner in his home district of Nalanda. Even today Nitish's ...
Cached Medicine News:Health News:MRI Scan Insufficient For Diagnosing Multiple Sclerosis 2Health News:Patients on NSAIDS have reduced gastric ulcers risk by Nexium? 2
... TheraSeed® Pd-103 implant is a combination of ... visibility that makes TheraSeed® treatment an ideal ... be confident that every TheraSeed® implant order ... which is required by clinicians who must ...
... designed to help you achieve one important ... procedure. All needles are engineered for exceptional ... for smooth entry and exit. A broad ... an ideal match with procedural needs and ...
... a combination of innovative design, consistently reliable ... I-125 implant an ideal choice for your ... every BrachySource I-125 implant order is backed ... required by clinicians who must meet the ...
... drainage from the ureteropelvic junction to the ... segment with no sideports prevents postoperative narrowing ... of the ureteral wall to the stent. ... one-time use. CAUTION: Periodic evaluation is advised; ...
Medicine Products: