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Aneurysm clinical trials

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NCT ID: NCT02266719 Enrolling by invitation - Clinical trials for Aortic Aneurysm, Abdominal

Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices

Start date: December 1, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the clinical outcomes and radiation of the use of off-the-shelf and custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms in patients having appropriate anatomy. The study consists of three cohorts. The first 2 cohorts are the continuation of the current IDE study. The first cohort is aimed to assess the use of custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy (Fenestrated-CMD cohort). The second cohort (Type I-III thoracoabdominal cohort) includes standard and high-risk patients with type I- III thoracoabdominal aneurysms that require the use of branched/fenestrated CMDs, or, in selected cases, the Zenith Thoracoabdominal Branch (Zenith® t-Branchâ„¢) device. Finally, the third cohort (the Arch cohort) will include 25 high-risk patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop

NCT ID: NCT02266342 Completed - Aortic Diseases Clinical Trials

GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

Start date: October 2014
Phase:
Study type: Observational [Patient Registry]

This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.

NCT ID: NCT02264977 Completed - Clinical trials for Aneurysm of Aortic Arch

Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch Aneurysms

Start date: April 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the early feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the aortic arch

NCT ID: NCT02259504 Completed - Clinical trials for Small Intracranial Aneurysms

COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils

COAST
Start date: July 2014
Phase: N/A
Study type: Interventional

This is a prospective, single-arm, multi-center post-marketing Study. The Study will commence as a single phase, with an optional second phase to follow at the discretion of the sponsor. Up to 300 eligible Subjects with small (< 4.9 mm) intracranial aneurysms, who consent to Study participation, will be treated in Phase 1 with MicroVention HyperSoft® 3D and HyperSoft® Helical coils with or without balloon remodeling or stent assistance at the discretion of the treating physician. The operator, at his/her discretion, may choose to frame the aneurysm with HyperSoft® 3D or any other bare metal coil but must finish the remainder of the aneurysm with HyperSoft® 3D and/or HyperSoft® Helical coils. At the discretion of the sponsor, additional patients, up to 300 patients total for the overall Study, with eligible aneurysms will be enrolled into Phase 2. In Phase 2, the aneurysm must be framed with a HydroFrame® or HydroSoft® 3D coil and filled/finished primarily with hydrogel coils. The intent to treat is to frame, fill and finish with all hydrogel coils. However, at the discretion of the treating physician, a bare platinum coil may be used to fill or finish, as long as a minimum of 50% (in total coil length) of hydrogel coils are used. Data will be collected on immediate and post-treatment angiographic occlusion rates (RRGS), new peri-procedural imaging-confirmed hemorrhage or ischemic stroke, neurological morbidity and mortality rates, recurrence rates, bleeding rates, retreatment rates, serious adverse events, >150 day angiographic occlusion rates (RRGS) and occlusion status. This will serve to establish the acute and sustained efficacy of EVT of small intracranial aneurysms with the specified microcoils, aided by balloon and/or stent remodeling where appropriate.

NCT ID: NCT02256163 Completed - Clinical trials for Thoracic Aortic Aneurysm

Identification of Genes and Pathogenesis Involved in Familial Thoracic Aortic Aneurysm

TAA
Start date: June 2011
Phase: N/A
Study type: Observational

The primary objectives of the study are - to assess the contribution of alteration of each known gene on non-syndromic TAA. - to map and identify unknown gene involved in the non-syndromic TAA.

NCT ID: NCT02253082 Completed - Clinical trials for Endothelial Dysfunction

Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)

VIPER-OCTA
Start date: November 2014
Phase: Phase 4
Study type: Interventional

Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated pilot trial

NCT ID: NCT02236923 Completed - Aortic Aneurysm Clinical Trials

Study of the Influence of the Moon and Seasons On Outcomes Following Surgery To Repair Ascending Aortic Dissection

ACS-MOON-1
Start date: January 1998
Phase: N/A
Study type: Observational

That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter length of stay in patients undergoing repair of aortic dissection, after adjusting for seasonal effects, demographics and cardiovascular risk factors.

NCT ID: NCT02229370 Recruiting - Clinical trials for Extracranial Carotid Artery Aneurysm

Carotid Aneurysm Registry

CAR
Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

To prospectively collect data on ECAA we designed the Carotid Aneurysm Registry (CAR). The aim of this study is to collect data on ECAA and its treatment to assess the natural history of ECAA and the success and safety of different treatment strategies.

NCT ID: NCT02229006 Completed - Clinical trials for Abdominal Aortic Aneurysm

Sodium Fluoride Imaging of Abdominal Aortic Aneurysms

SoFIA3
Start date: September 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of abdominal aortic aneurysm expansion.

NCT ID: NCT02225756 Recruiting - Clinical trials for Small Abdominal Aortic Aneurysm

Cyclosporine A in Patients With Small Diameter Abdominal Aortic Aneurysms

ACA4
Start date: December 2013
Phase: Phase 2
Study type: Interventional

Aneurysms of the aorta are dilatations of the main artery in the body that distributes blood to organs. Aneurysms expose patients to aortic rupture. The risk of aortic rupture is high for large aneurysms, and low for small aneurysms. Currently, if the diameter of a small aneurysm grows up to a level at risk for rupture, surgery is indicated to prevent rupture. A drug that would stop growth of small aneurysms would obviate aortic surgery, the current treatment to prevent aortic rupture in patients. The ACA4 study aims at testing the possibility to stop growth of small aortic aneurysms in the abdomen with a drug, cyclosporine A. Patients with small aneurysms will receive cyclosporine A orally, or a placebo (fake liquid), every day during a short period of time. Efficacy of the drug will be evaluated by measuring the diameter of the aneurysm during 2 years after treatment cessation. Drug safety analysis will evaluate the impact of the drug on renal function, blood pressure, and other parameters. In case of adverse event during the drug administration phase, dose of the drug or of the placebo will be decreased or administration stopped.