View clinical trials related to Aortic Dissection.
Filter by:Aortic dissection is a life-threatening condition and a consequence of a tear of the innermost of the three aortic layers- the intima. When a tear occurs, blood surges through the tear and causes the flow of blood between the aortic layers, causing a "false lumen". This causes a weakening of the aortic wall and hinders the blood from reaching its target organs and life saving emergent surgery is performed as routine. Approximately 20% of patients undergoing acute type a aortic dissection (ATAAD) surgery suffer from postoperative neurological injuries and It has been demonstrated that neurological injuries account for 10-15% of in-hospital deaths. In association with other cardiac procedures where the left side of the heart is opened and air may be trapped within the arterial circulation, carbon dioxide flooding is used to displace open air from the surgical wound. In comparison to air, carbon dioxide is significantly more soluble in blood and may therefore decrease the risk of air embolism. In cardiac surgery, carbon dioxide flooding has been demonstrated to reduce levels of biomarkers of cerebral injury, but carbon dioxide is not routinely employed in ATAAD surgery and has not been studied in association with these procedures. The hypothesis is that carbon dioxide flooding reduces cerebral air embolism and the aim of this project is to evaluate whether carbon dioxide flooding may reduce neurological injuries following ATAAD surgery. This is a prospective, randomized, controlled, patient- and reviewer blinded interventional study. Patients will be randomized to undergo surgery with carbon-dioxide flooding at 5L/min to the open chest cavity or conventional surgery without carbon dioxide flooding. Remaining aspects of the procedure will be identical. The patient, external statistician and the reviewer analyzing the primary endpoints will be blinded for the randomization arms. The study will assess the following endpoints: Primary outcomes: Presence, number and volume of ischaemic lesions observed using magnetic resonance imaging (MRI) after ATAAD surgery. Secondary outcomes: Clinical signs of neurological injury. Levels of biomarkers of neurological injury (S100B, neuron specific enolase (NSE) , neurofilament protein (NFL), Glial fibrillary acid protein (GFAP) , Ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and Tau-protein (TAU)) before and after surgery. Quality of life, postoperative recovery and neurological function after ATAAD surgery. Primary outcomes in relation to retrograde cerebral perfusion. Start of inclusion is anticipated to start Jan 1st, 2022. The writing of a manuscript describing the study methods and study objectives is expected to be started in 2021 and the final manuscript is expected to be written during 2025. An interim analysis of the primary endpoints and the safety arm will be performed after 40 patients have been randomized. An external statistician together with the principle investigator will hereafter decide for the study to be continued or terminated due to harms, futility or superiority. The safety arm will include intraoperative mortality, in-hospital mortality, re-operation for bleeding, stroke, myocardial infarction or other thromboembolic events. Update August 2023: Interim analyses were performed after 40 study participants had been included. Results from the interim analyses raised important questions which need to be assessed by a Data Safety and Monitoring Board (DSMB). Since there are no documented harmful effects of the intervention, a DSMB was not appointed before initiation of the trial. The study was suspended on Aug 18th 2023. A DSMB will be appointed, analyze the interim analyses, collect necessary additional information and make a recommendation to the PI whether the study is may proceed or is to be terminated prematurely. Update September 2023. The DSMB has reviewed the interim analyses and additional study data. The DSMB concluded that there was no reason to terminate the study and have recommended for the study to proceed. Recruitment was re-initiated on September 5th 2023.
Aortic disease is a life-threatening condition requires swift surgery or intervention. With modern techniques and vascular prostheses, still quite a few patients suffer surgery/intervention related complications such as suture line pseudoaneurysm, stent- induced re-entry tear, and aneurysmal expansion. Previous studies suggest that these complications may be related to the abnormal aortic motion pattern and biomechanical stress induced by vascular prostheses. The relationship between aortic motion changes and aortic adverse events after treatment still remains unclear. A dynamic protocol (multiphase contrast-enhanced ECG-gated) CT scan is able to measure the spatial motion of the ascending aorta, and finite element modelling is able to simulate both surgery or endovascular intervention and analyse the biomechanical interaction between vascular prostheses and tissue based on the patient-specific images. This project is aiming to explore and identify the interaction of 4D aortic motion and the biomechanical changes after surgery or endovascular treatment.
Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of "occult" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases. Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have "no risk" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies. This study seeks to determine whether "low risk" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner: All blunt trauma victims undergoing computed tomography of the abdomen/pelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal/pelvic/flank pain, abdominal/pelvic/flank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study. The criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of "low-risk" patients that do not have significant abdominal or pelvic injuries.
Anatomopathological classifications have been well identified in aortic dissection with important therapeutic implications. The authors evaluated the inflammatory response in patients with aortic dissection (AD) and assessed the presence of distinct inflammatory subphenotypes within this disease.
Aortic dissection is a life-threatening condition caused by a tear in the internal layer of major artery wall (aorta) that carries blood to all body organs, resulting in separation of the aortic wall layers (dissection). The dissected aorta compromises blood flow to any organ, and eventually leads to organ damage (Malperfusion Syndrome). Our goal in this project is to use Intravascular Ultrasound (IVUS) to have real time assessment and confirm any evidence of malperfusion syndrome in the setting of aortic dissection after repairing the original aortic tear. IVUS is a small ultrasound (sound waves) wand that is attached to the top of a thin tube. This tube is inserted into the aorta from the groin. This device takes pictures of the aorta and its major branches, to identify problems with blood flow. Having this real-time and dynamic assessment will help to identify any malperfused organs before leaving the operating room and allow us to address the malperfusion syndrome as quickly as possible to limit complications. Without this technique, identifying the problem can take several days after surgery at which point there can be irreversible complications.
This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system manufactured by EndoNom Medtech (Hangzhou) Co., Ltd.
This study is the first in man study of WeFlow-Arch Module Embedded Aorta Arch Stent Graft System
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.
The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.