Abdominal Aortic Aneurysm (AAA)

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.

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 aneurysm's 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 the safety and effectiveness of the IMPEDE-FX RapidFill device used alongside standard endovascular aneurysm repair (EVAR) to treat abdominal aortic aneurysms (AAA). The study aims to increase the percentage of patients experiencing shrinkage of the aneurysm sac after treatment. This trial is conducted by Shape Memory Medical, Inc. and focuses on patients who are candidates for elective EVAR due to an infrarenal fusiform aortic aneurysm. Participants will be randomly assigned to one of two groups: the treatment group, which will receive both an EVAR stent graft and IMPEDE-FX RapidFill implants to fill the aneurysm sac, and the control group, which will receive only the EVAR stent graft. The IMPEDE-FX RapidFill device is a medical implant designed to fill the flow lumen within the aneurysm sac. Treatment follows standard EVAR procedures using approved stent graft devices. During the study, participants will be monitored for aneurysm sac regression at one year as the primary effectiveness measure. Safety is evaluated by tracking major adverse events within 30 days of the procedure. Follow-up includes assessments of aneurysm size and complications related to the treatment. The overall participation will last at least one year, with regular check-ups to observe aneurysm healing and patient safety.

Researchers are evaluating the preliminary safety and effectiveness of an infusion of allogeneic adipose tissue-derived mesenchymal stem cells into the aneurysmal sac for treating abdominal aortic aneurysm (AAA). This Phase IIa, single-center clinical trial compares the investigational treatment with historical patient groups to better understand its potential benefits and risks for patients with AAA who require endovascular treatment. The investigational treatment involves a single local injection of expanded allogeneic adipose tissue-derived mesenchymal stem cells delivered via catheter directly into the aneurysm sac during the endovascular AAA procedure. The dose is calculated as 10 million cells per kilogram of patient body weight. These stem cells are classified as an advanced therapy medicinal product under European regulations. Participants will be monitored for safety over 12 months following treatment, and the effectiveness of the intervention will be evaluated at 6 months. Study visits will include assessments and procedures to track patient health and aneurysm stability. The total duration of involvement includes these follow-up periods to ensure comprehensive monitoring of outcomes and any potential side effects.

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 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 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 device's 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 evaluating the feasibility and safety of using a device called AneuFix during abdominal aortic aneurysm repair surgery to prevent a complication known as an endoleak. This study focuses on patients with asymptomatic infrarenal abdominal aortic aneurysms who have a high risk of developing type II endoleaks after endovascular aneurysm repair (EVAR). The goal is to assess how well AneuFix performs when applied prophylactically at the time of EVAR implantation. The investigational device, AneuFix, is a polymer that quickly hardens after being injected into the aneurysm sac near the blood vessels causing the endoleak. It is administered by injection through transfemoral access during EVAR, guided by imaging to ensure precise placement. This treatment aims to block backflow in the blood vessels feeding the aneurysm sac and prevent endoleaks. The study is interventional and involves a single treatment group receiving the AneuFix device. Participants will be monitored for technical success within 24 hours after the procedure and clinical success at 6 and 12 months. Researchers will track complications during surgery and in the 30 days after, the occurrence of any type of endoleak, adverse events, need for further interventions, and aneurysm rupture over 1 year. Survival will also be followed for up to 24 months. Patients will undergo imaging and clinical assessments at scheduled times to evaluate outcomes and safety throughout the study period.