Onyx One Clear

A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients (Onyx ONE) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.

Onyx one clear. Onyx ONE Clear: A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear) Sponsor Name. Medtronic Vascular . NCT Number. NCT03647475. IDE Number. G140178. CMS Approval Date. 2018-09-28. Category. B. Following a DAPT interruption at one month on patients with a next generation DES, the Onyx ONE Clear Study by Medtronic (MDT) investigates risk of cardiac death, heart attack and stent thrombosis. Onyx-ONE Clear Objective. The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment receiving reduced duration (one month) of DAPT following stent implantation. “The client has a simple follow-up tool, more accurate data and clear criteria according to an unambiguous process.”. Onyx One, the contractor management platform of the industry. The client works with several contractors. The contractor works with several clients. No double admin. No double login or passwords.

The Onyx ONE Clear study will assess the use of one-month dual antiplatelet therapy (DAPT) in US and Japanese patients who are at high risk of bleeding. DAPT is a combination of aspirin and an anti-clotting drug. The study will evaluate its safety, such as any potential cardiac risks, when used with a next-generation DES.. Onyx healing properties sheds light on your inner truth in meditation practice because it's a chance for a one-on-one with you and the universe. This dark and brooding quartz keeps the mind free of societal expectations and self-doubt, leaving just you and your authentic self to contemplate your existence within the vast universe. The Onyx ONE Clear Study was designed to complement the Onyx ONE Global Study, results of which wererecently published in the New England Journal of Medicine 2. Together, the Onyx ONE Clear Study and the Onyx ONE Global Study make up the robust Medtronic Onyx ONE Month DAPT Program that has enrolled approximately 2,700 patients at up to 130. The Onyx ONE Clear Study was designed to complement the Onyx ONE Global Study, results of which wererecently published in the New England Journal of Medicine 2. Together, the Onyx ONE Clear Study and the Onyx ONE Global Study make up the robust Medtronic Onyx ONE Month DAPT Program that has enrolled approximately 2,700 patients at up to 130.

The Onyx ONE Clear Study was designed to complement the Onyx ONE Global Study, results of which were recently published in the New England Journal of Medicine [ii]. Together, the Onyx ONE Clear Study and the Onyx ONE Global Study make up the robust Medtronic Onyx ONE Month DAPT Program that has enrolled approximately 2,700 patients at up to 130. The Onyx One is an advanced professional FFF 3D printer – built to reliably produce strong parts for you. It’s built around an aluminum unibody frame that delivers high accuracy and repeatability. A hardened extrusion system enables the Onyx One to print Onyx — a micro carbon fiber filled nylon filament that destroys traditional extrusion. The Onyx ONE Clear study’s primary composite endpoint of cardiac death or myocardial infarction was 7%, beating the pre-specified performance goal of 9.7% at one-year post-procedure. The rate of stent thrombosis stood at 0.7% at one year. The performance goal was based on short-DAPT studies. A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear) (Onyx ONE Clear) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

The company noted that Onyx ONE Clear Study has been designed in a manner similar to the randomized Onyx ONE Global Study, which began enrollment in late 2017. Both the studies have been built on. The Onyx ONE Clear study’s primary composite endpoint of cardiac death or myocardial infarction was 7.0%, beating the pre-specified performance goal of 9.7% at one-year post-procedure. The rate. The ONYX ONE trial showed that Resolute Onyx DES implantation is noninferior to BioFreedom DCS, both with 1-month DAPT among patients undergoing PCI and with high bleeding risk. Description: The goal of the trial was to compare the safety and efficacy of 1 month of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention. The Onyx ONE Clear Study was designed to complement the Onyx ONE Global Study, results of which wererecently published in the New England Journal of Medicine 2. Together, the Onyx ONE Clear Study and the Onyx ONE Global Study make up the robust Medtronic Onyx ONE Month DAPT Program that has enrolled approximately 2,700 patients at up to 130.

A cross-section of Medtronic’s Resolute Onyx Core Wire technology. Medtronic has announced the start of the Onyx ONE Clear Study in the USA and Japan that will evaluate one-month dual antiplatelet therapy (DAPT) in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention (PCI). Inform third parties or your own employees about the job and the associated risks. It shows, in a clear way, which measures must be taken to reduce these risks to a minimum. If desired, a knowledge test can be linked to the toolbox. Via the Onyx One platform you can register participation and test results. Onyx ONE Clear Analysis 752 HBR patients from the United States and Japan in a prospective, multicenter, single-arm trial; Pooled with similar “clear” Resolute Onyx DES patients from the Onyx ONE Global Study ~1,500 total patients included in primary endpoint analysis “Clear” patients are defined as being event-free # and Onyx ONE Clear is a prospective, single arm study to assess the clinical safety and effectiveness of 1-month DAPT in HBR patients treated with Resolute Onyx, and is the pivotal Resolute Onyx 1-month DAPT labeling study for the US. DAPT was required for 1 month followed by single antiplatelet therapy in patients event-free and adherent to DAPT.

Onyx ONE Clear Study . The first study in the United States and Japan evaluating 1-month DAPT duration in HBR patients with a current DES. Study Details Prospective, multicentre, single-arm trial; 601 HBR patients pooled with similar “clear” Resolute Onyx DES patients from the Onyx ONE Global Study ~1,500 patients included in primary.