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Aortic Dissection clinical trials

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NCT ID: NCT04068337 Completed - Aortic Aneurysm Clinical Trials

Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement

Start date: August 1, 2018
Phase:
Study type: Observational

The Freestyle® prosthesis (Medtronic plc, Dublin, Ireland) is a biological, porcine aortic root implanted in various combinations and techniques since the 1990s. The main indication for the choice of this prosthesis is a combined pathology with degenerated aortic valve and additional dilatation of the root often involving the ascending aorta. The Freestyle® prosthesis is also used in cases of dissection of the ascending aorta with the involvement of the aortic valve, which opens the debate on how far the ascending aorta should be replaced for a sustainable solution with calculable low periprocedural risk. Considering a lower intraoperative risk in the life-threatening situation, an extended resection of the aorta can be avoided and only the aortic root replaced with a piece of ascending aorta. On the contrary, focusing on improved long-term outcome, the technique of total arch replacement in aortic dissection was developed in emergency situations with acceptable results, which, however, were often reproducible only in large, experienced centers. Apart from the abovementioned options, the technique of proximal arch replacement can provide a tension-free anastomosis. The intention of hemiarch replacement is the attachment of the prosthesis to an aneurysm-free portion of the aortic arch helping to protect against further anastomotic aneurysms and spare the patient complex reoperation or interventional procedures in the future. As a possible drawback of the technique, especially in emergency situations, the potentially prolonged duration of surgery and the need of selective brain perfusion via axillary or carotid artery are discussed increasing the risk of stroke and further major events, which could not be reflected in current literature. However, there is still no convincing evidence of a long-term benefit in terms of re-operation and survival after hemiarch replacement. The aim of this retrospective analysis was to assess the mid-term outcome of the biological Freestyle® prosthesis in combination with operations on the ascending aorta and the aortic arch with regard to prosthetic performance, reoperations, stroke and death.

NCT ID: NCT03647566 Completed - Aortic Dissection Clinical Trials

18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

FAASt
Start date: October 1, 2018
Phase:
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 predict disease progression in acute aortic syndrome.

NCT ID: NCT03030521 Completed - Aortic Dissection Clinical Trials

The Roles of Intraluminal Pressure and the Dilation of Tunica Media in the Development of Aortic Dissection

Start date: January 30, 2017
Phase: N/A
Study type: Observational

Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why some aortic dissection are limited in extent while other aortic dissection extend extensively. The investigators hypothesize that the medial layers are separated as a result of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis is ture, dilation is necessary to the development of aortic dissection. In this study, an in vitro experiment was performed to test whether dilation is essential to the development of aortic dissection. Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation. Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly, the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of the experimental group was bound by a band to restrict its dilation in the next step. Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly, for the experimental group, the band is removed, and the syringe is filled with red stain. The mechanical test is performed again. Finally, the tissue sheet is released and cut into several parts to show whether the inner and outer media layers are separated by the blue stain or the red stain.

NCT ID: NCT02724072 Completed - Aortic Aneurysm Clinical Trials

Thoraflex™ Hybrid IDE Study

Start date: August 22, 2016
Phase: N/A
Study type: Interventional

The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta. The study will also assess safety and early clinical outcomes in patients who receive an extension procedure within 1 year of Thoraflex™ Hybrid Device implantation. Lastly the study will assess the safety and clinical outcomes of patients who receive a Thoraflex™ Hybrid Device for treatment of a ruptured aorta. Patients will be followed for 3 years. The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1 year post-procedure.

NCT ID: NCT02663739 Completed - Aortic Dissection Clinical Trials

Zenith® TXD Post-market Surveillance in Japan

Start date: March 2015
Phase:
Study type: Observational

The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval

NCT ID: NCT02375542 Completed - Aortic Aneurysm Clinical Trials

Characterization of Aortic Tissue at Reoperation

Start date: February 2015
Phase:
Study type: Observational

This study will analyse factors contributing to cardiac re-operation to determine causative effects

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: NCT02086136 Completed - Aortic Dissection Clinical Trials

Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection

ADvISED
Start date: September 2014
Phase:
Study type: Observational

Acute aortic dissection (AD) is a deadly, difficult to diagnose disease presenting with an array of common and unspecific symptoms. Aortic dissection detection (ADD) risk score is a bedside clinical tool to estimate the risk of AD. D-dimer has been evaluated in several studies as a biomarker of AD and has showed a pooled diagnostic sensitivity of 97%. However, considering the severe morbidity and mortality of AD, a negative d-dimer per se is considered insufficient to rule-out AD in unselected patients. The aim of the present study is to evaluate whether the diagnostic performance of d-dimer differs in patients at different clinical risk of AD, and in particular whether a negative d-dimer test may allow safe rule-out of AD in any patient subgroup without necessity to perform urgent aortic imaging. Consecutive adult patients with suspected AD presenting to Emergency Department will be enrolled before the establishment of a final diagnosis; a standardized clinical form comprehensive of presence/absence of 12 risk markers allowing ADD risk score fulfilled and d-dimer levels measured at presentation. The aortic imaging exam used to confirm or refuse of AD will be computed tomography angiography or transesophageal echocardiography and final diagnosis established after reviewing of all available data. The accuracy, failure rate and efficiency of a diagnostic strategy combining standardized clinical stratification via the ADD risk score with d-dimer testing will therefore be assessed.

NCT ID: NCT02046460 Completed - Clinical trials for Cervical Artery Dissection

Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection - TREAT-CAD

TREAT-CAD
Start date: September 2013
Phase: Phase 3
Study type: Interventional

Primary objective: To demonstrate the non-inferiority of acetylsalicylic acid (ASA) to anticoagulant treatment (vitamin K antagonists) in CAD-patients with regard to outcome and complication measures. Methods: Randomized controlled, open labeled multicenter, non-inferiority trial with blinded assessment of outcome events. Primary endpoint: Primary composite outcome measure - labeled Cerebrovascular Ischemia, major Hemorrhagic events or Death (CIHD) - includes the following efficacy and safety outcome measures during the treatment period: (i) occurrence of any stroke*, new acute lesions on diffusion weighted MRI (ii) any major extracranial hemorrhage, any symptomatic intracranial hemorrhage and any asymptomatic micro- or macrobleeds, (iii) death.

NCT ID: NCT01782534 Completed - Aortic Dissection Clinical Trials

Logistic Regression of Risk Factor for the 5-year Mortality of Aortic Dissection

Start date: August 2002
Phase: N/A
Study type: Observational

The relevant predictive hospital risk factors for 5-year mortality of patients with aortic dissection is untill unlear. The aim of this study is to collect the clinical data of 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug. 2007, and statistically analyze the hospital risk factors related to 5-year mortality by univariate and multivariate binary logistic regression.