Clinical Research Directory

A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement

The goal of this prospective, non-randomized trial is to determine the safety and technical success of a novel modification to a U.S. Food and Drug Administration (FDA)-approved hybrid frozen elephant trunk (FET) device (Thoraflex Hybrid, Terumo Aortic). The modification is intended to enable supra-aortic vessel stenting in patients undergoing aortic arch replacement for aortic aneurysm or dissection.

Prehabilitation for Aortic Aneurysm Surgery: Proof-of-concept Trial

This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program, a 6-week collaborative care intervention to help prepare individuals for repair of aortic aneurysms.

Laser In Situ Fenestration Study

The goal of this clinical trial is to learn about a new device, named the LIFE device, to treat people with aneurysms (swellings) in the aorta (large, main blood vessel that delivers blood from the heart to the body). The main questions this trial aims to answer are: * If the LIFE device works to treat aortic aneurysms * What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years have their pulses checked, bloodwork to check kidney function (BUN and serum creatinine), and a CT scan of the aneurysm area.

Cerebral Protection in Aortic Arch Surgery

Aortic arch repair surgery is a technically complex and challenging procedure to treat aortic pathologies. Despite advancements in perioperative care, detrimental neurological complications occur during or after surgery. The neurological complications increase the economic burden of healthcare, morbidity and quality of life for the patients, even if they survive. Stroke, for example, leads to an increase in healthcare and social care costs, requiring a subsequent lengthy rehabilitation. Milder neurological impairments include transient ischaemic attacks, confusion and delirium, necessitating longer intensive care and hospital stay. Currently applied cerebral monitoring modalities are electroencephalogram and cerebral oximetry. However, they are not specific enough to timely detect early cerebral ischaemia to prevent neurological complications. S100B protein and neuron-specific enolase are serum markers that reflect cerebral damage, however, their applicability in the hyperacute setting is limited. However, rapid measurements of glial fibrillary protein have paved new pathways to detect cerebral injury. Recent studies reveal more sensitive biomarkers of glucose, lactate, pyruvate, glutamate and glycerol. These biomarkers could potentially detect cerebral ischaemia on a near real-time basis using the microdialysis method. The aim of the project is to develop a bedside system for early detection of cerebral ischaemia on a near real-time basis during aortic arch surgery. Early detection of cerebral ischaemia could mandate more aggressive cerebral protection strategies by further optimisation of hypothermia and antegrade selective cerebral perfusion during surgery, and optimisation of blood pressure and oxygenation in the intensive care unit. Ultimately, early detection of cerebral ischemia during surgery will prevent disabling and costly neurological complications following surgery.

Ready for Recovery Pilot Trial

This is a three-arm, randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of two multicomponent interventions to promote recovery from aortic aneurysm repair procedures.

Research on Aneurysm Growth Prediction in Vascular Dilation Caused by Bicuspid Aortic Valve Based on VDM and CFD

Bicuspid aortic valve (BAV) is the most common congenital valvular malformation, characterized by heterogeneous phenotypic subtypes that predispose patients to secondary aortic pathologies, including valvular dysfunction and ascending aortic dilation. With approximately 50% of BAV patients developing aortic dilation, a prevalence that continues to rise, accurate assessment of postoperative aortic remodeling remains a critical unmet clinical need for early risk stratification and optimized therapeutic decision-making. Currently, clinical surveillance relies heavily on periodic manual measurement of the maximum aortic diameter on follow-up computed tomography angiography (CTA), yet this approach suffers from several inherent limitations. It is a lagging indicator that detects irreversible wall damage only after significant enlargement has occurred. It oversimplifies complex three-dimensional morphological changes into a single linear dimension. It exhibits substantial intra- and inter-observer variability. It is also inefficient for large-scale longitudinal data management. Although alternative metrics such as computational fluid dynamics (CFD) derived hemodynamic parameters and morphological geometric features have been explored, existing methods remain constrained by static single-time-point analyses that fail to capture the dynamic biomechanical evolution driving aneurysm progression, high technical barriers that preclude routine clinical integration, and a lack of comprehensive models that systematically integrate dynamic deformation, static anatomy, and hemodynamic information. To address these gaps, this study aims to develop a fully automated, quantitative, and dynamic risk prediction system that leverages vascular deformation mapping (VDM) for noninvasive early detection of regional aortic deformation, integrates multiparameter features including dynamic deformational, static anatomical, and hemodynamic characteristics through an artificial intelligence model, and delivers intuitive structured reports to directly support clinical decision-making, thereby enabling earlier intervention and improved patient outcomes.

Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.

ReiCo is a French retrospective, multicenter, single-arm study focused on assessing the safety and clinical performance of the iCover balloon-expandable covered stent (iVascular) when implanted as a bridging stent during fEVAR for complex abdominal aortic aneurysms. The aim is to demonstrate conformity by collecting clinical evidence supporting the safe and effective use of this device in fEVAR procedures.

A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta

The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta. This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels. The first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in a planned surgery. After the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in an emergency setting. Data will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.

Prospective Evaluation of Physician Modified Endografts for Aortic Disease

The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.

Radiation Free Study

This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable. Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)

Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.

Patients having a planned open surgery of thoracoabdominal aortic aneurysms and enrolled in the study will be randomized the day of the surgery in 2 groups: * Arm 1 : Patients with aortic clamping with pre-conditioning * Arm 2 : Patients with aortic clamping without pre-conditioning Patients will be then followed, during 60 days after surgery.

Identification of Genetic Causes of Calcific Aortic Valve Disease

This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.

Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery

The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery. Specifically, this research aims to investigate differences in pressure injury outcomes before and after the intervention, and to assess the preventive effectiveness of soft foam dressings as an adjunctive skin-protection strategy.

Familial Risk of AAA in Sweden

The aim is to study the prevalence of abdominal aortic aneurysm in first degree relatives and the risk to develop AAA in individuals with heredity for AAA compared with the population ( without heredity for AAA).The study i based on national registers in Sweden with high coverage and capacity of linkage between different registers.

Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)

Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface. The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable to diagnose aortic valve disease and aortic aneurysm. In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging, KCG recordings, phonocardiography (PCG) recordings, and video recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG, PCG and video signal.

Cardiovascular Health Improvement Project

The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls.

Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.

ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)

The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure. Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.

LLM-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Cardiac Surgery Patients

This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health management of patients after cardiac surgery. A total of 500 adult patients who undergo cardiac surgery (including coronary artery bypass grafting, heart valve surgery, great vessel surgery, congenital heart disease correction, and other cardiac procedures) at Beijing Anzhen Hospital will be randomly assigned in a 1:1 ratio to an intervention group or a control group, stratified by age (\<65 vs ≥65 years) and surgery type. The intervention group will use the LLM-based mobile health management application in addition to standard postoperative care, while the control group will receive standard postoperative care alone. The application integrates multimodal clinical data into a personalized health profile and provides surgery-type-specific postoperative management recommendations, medication adherence reminders, complication early warning, and cardiac rehabilitation guidance. The primary outcome is the composite endpoint of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke, or unplanned cardiovascular reoperation/reintervention, within 12 months after randomization. Secondary outcomes include health-related quality of life (EQ-5D-5L), cardiovascular rehospitalization rate, medication adherence (MMAS-8), postoperative complication rate, and cardiac rehabilitation achievement rate. Follow-up visits are scheduled at 1, 3, 6, 9, and 12 months post-randomization.

Prospective Aortic Biobank of POP-STAR

The overall objective of the POP-STAR project is individualized surveillance for patients diagnosed with abdominal aortic aneurysms by means of more precise, patient-specific AAA growth prediction.

AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation

This study will test how well an artificial intelligence (AI) software called Aorta AIM measures the size of the aorta (the body's main blood vessel) from CT scans. The aorta can become enlarged over time, which may lead to serious health problems. Doctors need to measure the aorta accurately to monitor patients and decide on treatment. Currently, doctors measure the aorta manually on CT scans, which takes time and can vary between different doctors. Aorta AIM is designed to measure the aorta automatically and consistently. In this study, researchers will compare Aorta AIM's measurements to those made by experienced radiologists or cardiologists (doctors who specialize in reading medical images). The study will use CT scans that have already been taken as part of routine medical care - no additional scans or procedures are needed. The study will include approximately 250 participants across multiple hospitals in Brazil and the United States. Participants will be adults who have had a chest or abdominal CT scan that shows their aorta. The main goals are to: * Check if Aorta AIM measures the aorta as accurately as radiologists * See if Aorta AIM can help doctors work more efficiently * Evaluate if the software works well in different hospital settings and with different types of patients This research may help improve how doctors monitor aortic disease and make treatment decisions in the future. There are no risks to participants since the study only uses existing medical images.

Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

Using 3D printing technology to create personalized models of diseased heart and aortic blood vessels, surgeons can perform preoperative planning and evaluate relevant indicators.

Multidisciplinary Analysis by Morphological and Mechanical Evaluation of the Aortic Wall in Patients Undergoing Cardiac Surgery.

Surgical indication in patients suffering from Ascending aorta aneurysm is currently based mainly on the maximum diameter of the aortic dilatation and on the yearly growth rate. Several clinical preoperative patients characteristics have been, potentially, correlated to impaired mechanical characteristics of aortic wall, and therefore to an increased risk of rupture and or dissection. On other hands, such suppositions have been never confirmed, as a full characterization of the mechanical behaviour of the ascending aortic tissue, especially in case of aneurysm, has not been fully clarified yet. Objective of this observational study is to better elucidate, using direct in vivo evaluation, the mechanical characteristics of the aortic wall in patients with ascending aorta diseases. Our study will have a further peculiar characteristic as we have the intention of compare such mechanical characteristics to those of patients, without known aortic diseases, undergoing heart transplantation. Potential correlation between, directly measured mechanical characteristics of the aortic wall, and preoperative parameters (anagraphic patients characteristics, clinical data and diagnostic tests) will be also investigated.

Thoraflex Hybrid and Relay Extension Post-Approval Study

The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.