Aortic Dissection

Researchers are evaluating the safety and effectiveness of the Rapidlink device in patients undergoing open surgical repair of the thoracic aorta involving the supra-aortic vessels, such as the left subclavian artery, left common carotid artery, and innominate artery. The study addresses challenges in repairing these vessels during surgery, aiming to simplify and speed up the process while reducing the need for additional procedures. This is an interventional study sponsored by Vascutek Ltd. focusing on patients with aortic disease requiring vessel repair or replacement. Participants will have the Rapidlink device implanted in one or more of the supra-aortic vessels during their planned or emergency open thoracic aorta surgery. The device consists of a graft section attached to a stented section, designed to be placed with minimal sutures and manipulation. The study first enrolls 32 patients undergoing left subclavian artery repair or replacement, then expands to include other supra-aortic vessel repairs. Up to 30 additional patients will be enrolled in an emergency setting after the initial group. Participants are evaluated before, during, and after surgery, with follow-up visits at discharge, 30 days, 3 months, 6 months, 12 months, and 24 months. Evaluations include safety and clinical success measures, occurrence of adverse events such as stroke or vessel rupture, device integrity, and need for secondary interventions. The primary outcome is the absence of major adverse events six months after the procedure. Data collection involves clinical assessments and monitoring to understand the devices performance and safety over two years.

Researchers are conducting a prospective, multicenter, randomized trial to assess the effectiveness and safety of the Sperstent peripheral spot stent system compared to the Everflex self-expanding peripheral stent system. The study focuses on treating residual lesions such as stenoses and dissections that remain after balloon angioplasty in the femoral and proximal popliteal arteries. These conditions are common in patients with peripheral arterial disease and affect blood flow in the legs. Participants will receive either the Sperstent peripheral spot stent system or the Everflex self-expanding peripheral stent system during endovascular treatment following percutaneous transluminal angioplasty PTA. Both treatments involve placing a stent to open narrowed or blocked arteries, guided by digital subtraction angiography DSA. The trial compares these two devices to understand their impact on artery patency and safety over time. Throughout the study, participants will be closely monitored with follow-up assessments including imaging to check artery openness, clinical evaluations of symptoms using Rutherford classification and ankle-brachial index ABI, and tracking of major adverse events. Key outcomes include primary patency at 12 months and freedom from major adverse events at 30 days after the procedure. The study period includes evaluations immediately after treatment and at 30 days, 6 months, and 12 months to monitor device success, procedural success, and changes in clinical status.

Research materials such as study invitations, information sheets, and consent forms are important for helping people understand health research and decide whether to participate. However, these documents are often too complex, lengthy, or technical, which can cause confusion or anxiety. This study focuses on improving the clarity, accessibility, and acceptability of recruitment materials for research involving people with thoracic aortic disease, a condition requiring regular monitoring. Participants, who are staff and students from the University of Nottinghams School of Health Sciences, will review draft recruitment materials including invitations, information sheets, and interview guides. They will provide feedback on how easy the documents are to read, the clarity of information, the tone, and the amount of information provided. A readability tool will also be used to assess whether the materials are written at an appropriate level for the public. Participants will give feedback through an electronic form taking about 15 to 20 minutes to complete. If more depth is needed, a small number may be invited to follow-up interviews or a focus group. The study measures how clear and acceptable the materials are over up to 24 weeks. Confidentiality is protected, and participation is voluntary with the option to withdraw at any time. The findings will help improve research materials for future studies involving thoracic aortic disease patients.

Researchers are evaluating outcomes of thoracic endovascular aortic repair TEVAR in patients with compromised distal landing zones CDLZs in the descending thoracic aorta. This observational study focuses on complications such as stent graft migration, type 1B endoleaks, and new tears caused by suboptimal distal landing zones, which can lead to further aortic damage. The study aims to compare different approaches for improving the distal landing zone seal to reduce major complications after TEVAR. Participants receive one of several types of stent-graft devices distal active fixation stent-grafts, distal scallop custom-made stent-grafts, distal Aptus Heli-FX EndoAnchors, or standard thoracic stent-grafts. These devices are designed to improve the durability of TEVAR by enhancing the seal at the distal end of the stent. The study observes and collects data on these different device types to assess their impact on patient outcomes. During the study, participants will be monitored with follow-up evaluations at 3 months to assess the presence of type 1B endoleaks and other complications related to the distal landing zone. Outcomes are measured by imaging and clinical assessments to understand how well each device performs in sealing the aorta. The study is conducted by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and will continue through November 2027.

Researchers are investigating acute aortic syndrome AAS, a serious and life-threatening heart condition where inflammation plays a significant role in its development and progression. This large observational study involves 20 cardiovascular centers in China collaborating to understand inflammatory responses and anti-inflammatory treatments in patients undergoing surgery for AAS. The study aims to assess how inflammation and anti-inflammatory strategies affect patient outcomes after surgery, including complications and survival. The study enrolls adult patients who have undergone surgery for AAS, which includes various types of aortic injuries such as dissection, penetrating ulcers, or hematomas. Participants may have received medical therapy, open surgery, endovascular repair, or hybrid procedures, sometimes combined with other cardiac surgeries. Data about their inflammatory responses and clinical results are collected through designed forms and analyzed using statistical software. This observational study began in 2016 and will continue enrolling patients until 2040. Participants will be followed over time to evaluate key outcomes like severe inflammatory reactions within 7 days after surgery and operative mortality within 30 days. Researchers will also monitor other complications such as organ dysfunction, stroke, kidney injury, infections, bleeding, and length of intensive care stay. The study gathers detailed information through clinical data collection and monitors these outcomes to better understand and improve management for patients with AAS over the long term.

Researchers are evaluating the accuracy and efficiency of an artificial intelligence AI software called Aorta AIM in measuring the size of the aorta, the bodys main blood vessel, using CT scans. The study focuses on comparing Aorta AIMs automated measurements with those made manually by experienced radiologists or cardiologists. This research aims to improve how doctors monitor aortic enlargement, which can lead to serious health problems, by providing a consistent and faster measurement method. The study involves retrospectively collecting chest or abdominal CT scans from adults aged 22 and older taken as part of routine medical care between January 1, 2016, and August 31, 2025. These scans will be analyzed by both the Aorta AIM software and expert radiologists who manually measure aortic diameters. The software provides standardized measurements at specific anatomical locations, and any discrepancies between manual readers are resolved by a senior expert for an accurate reference standard. Participants have already undergone CT imaging, so no additional scans or procedures are required. Researchers will review the collected data to compare measurement accuracy, processing time, and clinical acceptability of the AI software against expert assessments. The main outcome is the average difference between AI and expert measurements. Secondary outcomes include agreement limits, measurement reliability, software yield, processing speed, and expert clinical acceptability scores. The study includes about 250 participants from multiple hospitals, with no risks since only existing images are used.

Researchers are exploring the use of presepsin, a biomarker valuable for diagnosing sepsis and predicting postoperative inflammatory complications, in patients undergoing thoracic aorta surgery. This study aims to improve antibacterial therapy decisions based on presepsin levels to reduce infection-related complications after surgery. Previous findings suggest presepsin levels can indicate risks for adverse outcomes during the postoperative period in cardiac surgery patients. Participants undergo reconstructive thoracic aorta surgery and are monitored for presepsin levels at the end of surgery and six hours afterward. Those meeting specific criteriapresepsin above 519.5 pgml at surgery end and no increase after six hoursmay switch to an antibacterial treatment with ampicillinsulbactam 3 g every six hours for at least 72 hours. Patients with presepsin below this threshold continue on cefazolin 2 g every six hours for a minimum of 72 hours postoperatively. During the study, participants are observed for up to 10 days to track infectious complication rates, mortality, length of hospital and ICU stays, multiorgan failure, and the total number of patients with complicated courses. The study evaluates how adjusting antibacterial therapy based on presepsin dynamics may impact these outcomes, with close monitoring to assess safety and effectiveness throughout the postoperative period.

Researchers are investigating the anatomical features of the aortic arch, focusing on a common variant called the common origin of the innominate and left carotid artery CILCA, which has been linked to thoracic aortic disease TAD. The study aims to compare these anatomical characteristics in people with and without aneurysms, collecting data from five major European cardiovascular centers. This observational study involves analyzing CT scans of the aortic arch from two groups individuals without aneurysms requiring treatment and those with aneurysms that do require treatment. No interventions or treatments are administered instead, the study focuses on imaging data to understand differences in aortic arch anatomy. Participants undergo aortic arch CT scans at participating centers, and researchers measure changes and differences in aortic arch anomalies from baseline within 30 days. The study tracks these anatomical features to better understand their relationship to aortic aneurysms and potential risks. The total study period extends until December 2026.

Researchers are conducting a multicenter, randomized clinical trial to evaluate different surgical techniques for treating Acute Type A Aortic Dissection ATAAD. The study aims to compare the safety and effectiveness of arch-clamping techniques performed under mild and moderate hypothermia against Suns procedure using bilateral antegrade cerebral perfusion. The trial involves 306 adult participants diagnosed with ATAAD from multiple hospitals in China to better understand major adverse events and recovery outcomes after surgery. Participants undergo total arch replacement combined with frozen elephant trunk implantation, then are randomly assigned to one of three groups arch-clamping under mild hypothermia, arch-clamping under moderate hypothermia, or Suns procedure under moderate hypothermic circulatory arrest with bilateral antegrade cerebral perfusion. Each surgical method involves specific steps to restore blood flow and reconstruct arteries using grafts during the operation. During the study, participants are closely monitored for one year after surgery. Researchers assess major adverse events such as death, need for renal replacement therapy, stroke, and paraplegia. They also measure surgical factors including circulatory arrest time, cardiopulmonary bypass time, mechanical ventilation duration, and length of ICU stay. Follow-up evaluations help determine the safety and validity of the mild hypothermic arch-clamping technique compared to the others.

Researchers are conducting a single-center observational study to evaluate the clinical outcomes of patients who have undergone revascularization of the aorta or peripheral arteries at Asan Medical Center. This study includes both retrospective and prospective data collection on approximately 6,000 patients treated for conditions such as thoracic or abdominal aortic aneurysm, aortic dissection, penetrating aortic ulcer, and peripheral artery occlusive disease including chronic limb-threatening ischemia, claudication, and acute limb ischemia. The study collects data on treatments like EVAR, TEVAR, and PTA used for revascularization. Participants will be followed up through hospital visits or telephone calls at 1, 6, and 12 months, then at 3, 5, and up to 10 years after their procedures. The monitoring includes tracking major adverse limb events and any deaths. During follow-up visits, researchers will gather information on outcomes such as death from any cause, major adverse limb events, stroke, myocardial infarction, vascular complications, bleeding, procedure success, limb amputation, and the need for repeat interventions. The study aims to provide long-term clinical results over a 10-year period to better understand patient outcomes after these vascular procedures.