Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral...
Aortic AneurysmAortic Dissection3 moreThe purpose of this study is to determine if the SP-GRIPFLOW catheter (the catheter designed by Fuji Systems) is safe and how well it functions. The information from this research will be used to help decide if the device should be approved for sale in the European Union. The SP-GRIPFLOW catheter may not yet be used by investigators outside of the study. Through the study, FUJI will prove that the target flow as measured by the flow through the catheter(s)(cumulative flow for multiple catheters) was confirmed in 95% of cases.
Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases
Aortic DissectionAneurysm5 moreThere are no endoluminal stent systems available on the Chinese market for the effective treatment of aortic arch lesions (involving aortic arch aneurysms, aortic coarctation, aortic pseudoaneurysms, aortic ulcers, and intermural hematomas), and therefore this study is intended to be a prospective, single-arm study.
Barrow Ruptured Aneurysm Trial
Ruptured Cerebral AneurysmSubarachnoid Hemorrhage (SAH)With evolving endovascular technologies there is a growing debate centered on the relative safety and efficacy of the currently accepted alternatives for the treatment of ruptured cerebral aneurysms in the face of acute subarachnoid hemorrhage (SAH). The purpose of this study is to compare the safety and efficacy of microsurgical clipping and endovascular coiling of acutely ruptured cerebral aneurysms in a prospective, randomized fashion.
Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms
Thoracoabdominal AneurysmsThe primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections...
Aortic AneurysmThoracic1 moreThe purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. This study will also evaluate the current instructions for use and may direct changes to the delivery and deployment steps. The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B dissections.
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm (AAA)The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).
Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms...
Intracranial AneurysmThe purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use.
Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
Aortic AneurysmThoracoabdominalThe primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending...
Aortic AneurysmThoracic1 moreThe objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.
BGP Stent as Bridging Stent in FEVAR
Thoracoabdominal Aortic AneurysmWithout Mention of Rupture2 moreThe objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BeGraft Peripheral (BGP) balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in FEVAR (fenestrated endovascular aortic repair) for complex aortic aneurysms.