News | Thrombectomy Devices | March 08, 2016

SITS Open Stroke Trial to Include pREset Thrombectomy Device

Trial protocol is designed to compare mechanical thrombectomy with concurrent medical management alone for stroke treatment

SITS Open trial, mechanical thrombectomy devices. pREset, stroke treatment

March 8, 2016 — phenox GmbH announced participation in the SITS Open clinical trial, where pREset and pREset LITE thrombectomy devices have been included in the study device portfolio. pREset is one of only three devices to be used in the study.

Stroke is the second leading cause of death worldwide and the most common cause of adult disability in the western world. Ischemic stroke, caused by a blocked artery, is the most common type of stroke and it takes only minutes without oxygen for brain damage to occur and more brain cells die every minute that flow is blocked. The aim of physicians is to restore blood flow by opening the blocked artery as quickly as possible, thereby enhancing the patient’s survivability and preventing long lasting disability.

The positive outcomes of recent randomized clinical trials for mechanical thrombectomy, such as MR CLEAN, ESCAPE, EXTEND IA and SWIFT PRIME, have renewed interest in studies enrolling a large number of patients. The SITS Open protocol is designed to provide a higher level of evidence for mechanical thrombectomy through a direct comparison between mechanical thrombectomy and a concurrent control of medical management alone.

The Department of Neuroscience at Karolinska Institute, Stockholm, Sweden, is sponsoring the open, prospective, international, multicenter, controlled clinical trial. The protocol calls for enrolling 600 patients in total, 300 in each arm. Patients enrolled in the treatment arm will be done so at centers that currently perform thrombectomy for stroke and fulfill the quality and training criteria for neuro-interventions. Patients in the control arm will be enrolled by clinics that offer IV thrombolysis and neither practice thrombectomy nor refer patients with ischemic stroke to other clinics where thrombectomy is offered.

For more information: www.phenox.net

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Overlay Init