Aortic Dissection

Researchers are studying the safety and effectiveness of the Rapidlink device in patients who need repair or replacement of the supra-aortic vessels during open surgery for thoracic aortic disease. This includes conditions affecting the aortic arch, where traditional surgery can be challenging. The study aims to simplify and speed up the connection of grafts to these vessels using the Rapidlink device, which may reduce the need for extra surgical steps. The Rapidlink device consists of a Gelweave graft attached to a stented section with nitinol rings, delivered via a single-use system. The study includes two groups: up to 120 patients undergoing elective surgery and up to 30 patients undergoing emergency surgery. Initially, the first 32 elective patients will receive the device for left subclavian artery repair only. After that, enrollment will expand to include repair of any supra-aortic vessel in elective cases. Emergency cases will be enrolled after the first 32 elective cases. Participants will be evaluated before surgery, during the implant, at hospital discharge or 30 days, and at 3, 6, 12, and 24 months after surgery. Researchers will monitor major adverse events at 6 months, technical and clinical success of the device, rates of stroke, vessel rupture, device-related complications, and other clinical outcomes. Data collection includes assessments during hospital recovery and follow-up visits for up to 2 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.

This research aims to evaluate the effectiveness and safety of a new intraoperative stent system for treating acute type I aortic dissection, a serious condition where the inner layer of the aorta tears, causing life-threatening complications. This type involves the ascending aorta, aortic arch, and the entire aorta, and surgery is currently the only treatment option. The study compares this new stent system with the existing Frozen Elephant Trunk Technique to improve long-term outcomes by better reconstructing the aortic arch and preventing complications from residual false lumens. The study involves two groups: one receiving the new triple-branched stent graft implanted directly into the aortic arch and its branches during surgery, and the other undergoing the standard procedure of ascending aorta and arch replacement with the Frozen Elephant Trunk stent placed in the descending thoracic aorta. The new stent system aims to simplify surgery by reducing the need for multiple anastomoses and shortening the time of cerebral and lower body ischemia. Participants will be closely monitored through various assessments during and after surgery, including mortality within 30 days as the primary outcome. Secondary outcomes include death related to aortic dissection within 12 months, thrombosis of the false lumen, and technical success of the procedure. Follow-up will last up to one year to evaluate safety and effectiveness. The total study duration for each participant depends on surgical and follow-up schedules, with careful data collection at multiple time points.

This research focuses on thoracic aortic disease, a long-term condition requiring regular monitoring, and explores how recruitment materials for a future doctoral study can be made clearer and easier to understand. The study aims to assess the clarity, accessibility, and acceptability of draft research documents intended for people in surveillance programs. Improving these materials helps ensure patients can make informed decisions about participating in research related to thoracic aortic disease. Participants, who are staff and students from the University's School of Health Sciences, will review draft recruitment materials including a study invitation, an information sheet, and an interview guide. They will provide feedback on readability, clarity, tone, and information amount. The study uses a qualitative design with written feedback collected through an online form, and if needed, follow-up interviews or a focus group may be conducted to deepen understanding. Participants will spend about 15-20 minutes completing the feedback form, with some possibly invited to additional interviews or a focus group. Researchers will analyze the feedback using thematic analysis alongside a standard readability tool to assess the public suitability of the documents. The study measures the clarity of recruitment materials over a period of up to 24 weeks and ensures participant confidentiality and voluntary withdrawal at any time without penalty.

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 evaluating the effectiveness of two treatment approaches for adults with uncomplicated acute type B aortic dissection, a condition where a tear occurs in the part of the aorta outside the heart. This prospective, randomized clinical trial compares best medical therapy (BMT) alone versus BMT combined with thoracic endovascular aortic repair (TEVAR). The study aims to determine differences in all-cause mortality and major health events over five years, helping to establish a standard treatment protocol for this condition. Participants will be randomly assigned to one of two groups: one receiving best medical therapy alone, which includes medications like beta-blockers to control blood pressure and pain, and the other receiving TEVAR using FDA-approved devices along with the same medical therapy. The study will enroll 436 adults, and follow-up will continue for five years after treatment to monitor outcomes. During the study, participants will undergo various assessments, including imaging tests like CT scans, to evaluate the aorta's condition. Researchers will track mortality rates, major complications such as rupture or organ failure, and quality of life measures. The study is conducted at a single center and includes long-term follow-up to gather comprehensive data on safety and health outcomes.

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 body's main blood vessel, using CT scans. The study focuses on comparing Aorta AIM's 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 criteria—presepsin above 519.5 pg/ml at surgery end and no increase after six hours—may switch to an antibacterial treatment with ampicillin/sulbactam 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.