Abdominal Aortic Aneurysm (AAA)

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.

Abdominal aortic aneurysm AAA is a serious vascular condition involving the enlargement of the abdominal aorta, which can lead to rupture and life-threatening bleeding. Because AAA often shows no symptoms until rupture, early detection and accurate monitoring are essential. This research focuses on evaluating computed tomography angiography CTA as a key imaging method to improve diagnosis and risk assessment for AAA. The study collects CTA imaging results from patients with AAA seen in inpatient, emergency, and outpatient settings at the study hospital. CTA provides detailed images of the aneurysms size, wall thickness, thrombus presence, and relation to nearby structures. These details are important for making decisions about when to intervene and how to manage the condition. Participants will have their maximal abdominal aortic diameter measured using CTA within one month, along with tracking of rupture events, mortality, and other aneurysm characteristics. The study gathers important clinical data to help refine AAA screening and treatment timing. Participation involves undergoing CTA scans and data collection, with the aim to develop better assessment standards and personalized care for AAA 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 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 evaluating the outcomes of treating patients with elective Abdominal Aortic Aneurysm AAA using the ALTO stent graft device from Endologix Inc. This observational study focuses on assessing the results during and after the surgery, including early and late outcomes, in a multicenter experience. The study builds on decades of technological advancements in endovascular aneurysm repair, particularly highlighting the innovative sealing mechanism of the ALTO device. The ALTO device implantation involves placing an aorto-bisiliac endograft to exclude the aneurysm, using a low-profile platform designed for challenging anatomies. All eligible patients undergoing elective endovascular aneurysm repair EVAR with the ALTO device will be included based on their medical needs, anatomical suitability, and physician expertise. The study will collect data during the procedure and at set follow-up times to evaluate technical and clinical success. Participants will be monitored through follow-up visits lasting up to five years, during which researchers will assess technical and clinical success at 90 days, one year, and five years after treatment. Additional measures include operative time, radiation exposure, contrast medium usage immediately after the procedure, and aneurysm shrinkage at one and five years. Patients are expected to comply with follow-up evaluations to help researchers understand the devices performance and patient outcomes over time.

Researchers are conducting a prospective, single-arm observational study to collect data from whole-body magnetic resonance imaging WB-MRI scans of up to 100,000 adult participants aged 18 and older across multiple clinical sites in the United States. The study aims to evaluate the accuracy of WB-MRI screening in predicting clinically significant diseases, including cancer, metabolic diseases, aneurysms, and neurologic disorders, in people interested in proactive and advanced preventive healthcare. Participants must meet specific inclusion and exclusion criteria to ensure safety and appropriate enrollment. Participants will undergo a whole-body MRI scan as the primary procedure of the study. The study does not involve any treatment but focuses on diagnostic imaging to detect and assess clinically significant diseases. The study plans to follow participants for up to 10 years to monitor and evaluate outcomes related to clinically significant disease diagnoses and oncological findings using established scoring systems such as the ONCO-RADS score. During the study, participants will provide clinical, demographic, and medical history information and complete consent procedures. Researchers will collect and analyze data from the MRI scans and track diagnoses over the follow-up period. The study includes safety monitoring to exclude individuals with contraindicated medical devices or conditions that could pose risks. Participation involves attendance at clinical sites for imaging and data collection, with long-term follow-up to assess health outcomes over up to a decade.

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 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.