View clinical trials related to Aortic Aneurysm, Thoracic.
Filter by:As endovascular procedures become more complex, there is a growing need for 3D image overlay to assist with device guidance and placement. Currently, a 3D image is typically created intra-operatively using 3D rotational angiography (3D-RA) or cone-beam CT (XperCT). This 3D image may then be overlaid on live fluoroscopy to provide 3D guidance information (Dynamic 3D Roadmapping). Philips Healthcare multimodality overlay products allows registration of a pre-acquired MR/CT or 3D rotational image to live fluoroscopy.
The specific aims of this study are to: - Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements >40mm. - Assess the effect on MMP levels during treatment with losartan, an angiotensin II receptor blocking agent. - In the setting of losartan therapy for one year, evaluate the response of MMP levels in these patients, and clinical outcomes including effects on aortic growth rate
ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a 0.035" guidewire and positioned under fluoroscopic control. If necessary, an arterial conduit technique may be required to allow access to the arterial system. The soft tapered tip allows atraumatic insertion into the vessel, while the catheter and sheath are designed to provide excellent flexibility and control through tortuous arterial anatomy. Each individual stent graft device is supplied sterile and pre-loaded in a single-use delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin wall woven polyester and nitinol ring stents, which are attached to the fabric with braided polyester sutures. The delivery system central catheter is a stainless steel braided co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide significant torque control and strength, while also maintaining superior flexibility. The outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant coating. These materials provide very low friction force during device insertion and deployment together with enhanced flexibility of the delivery system. The handle components are moulded from thermoplastic polyurethane. The materials of the endoprosthesis are identical to those of the current Conformité Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal aortic aneurysm repair. The materials of the delivery system are well established in medical applications. The design of ThoraflexTM is based on the same principles as other clinically established thoracic endovascular devices. The endoprosthesis is constructed of self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal deployment position can be enhanced. The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta, which is identical to other CE approved thoracic endovascular devices.
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.
The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) was initiated in 2006 by the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). GenTAC established a registry of 3706 patients with genetic conditions that may be related to thoracic aortic aneurysms and collected medical data and biologic samples. The study ended in September 2016. Data and samples are available from NHLBI and requests should be made to BioLINCC. See the NHLBI website for more information: https://www.nhlbi.nih.gov/research/resources/gentac/.
The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October 1st, 2009. The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.
A prospective, non-randomized multi-center clinical evaluation of the performance of the TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic aortic aneurysms (TAA).
Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.
The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.