Clinical Research Directory

Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)

To evaluate the safety and effectiveness of the Heli-FX EndoAnchor system in AAA subjects who without augmented radial fixation and/or sealing due to an endoleak or migration are at high risk for aneurysm-related complications or who are at high risk of migration or endoleak complications post-procedure, and to support product registration of Heli-FX EndoAnchor system with the National Medical Product Administration (NMPA) in China.

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).

Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)

The study aims to check whether the TUVA BX and iCover stent grafts are safe and work well when used during a specific type of minimally invasive surgery (BEVAR) to treat complex aortic aneurysms. It is a retrospective study and it is conducted at multiple hospitals and does not include a comparison group. Researchers will collect and review patient data from medical records, starting from the original procedure and continuing through the 1-year follow-up visit.

Endurant CHevAr New Indication Trial: ENCHANT

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

Nectero EAST System Retreatment Study

This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.

Perioperative Hypotension and Survival After Elective AAA Repair

Background: An abdominal aortic aneurysm (AAA) is a localized dilatation of the infrarenal aorta that, when it meets critical criteria, can rupture and cause a vital emergency, requiring immediate surgery with a mortality rate close to 85%(1). Also, symptomatic AAA and/or imminent rupture is a surgical emergency that should be recognized and treated promptly. Elective procedures are usually performed in patients with AAA with a diameter greater than 5.5 cm in men and 5.0 cm in women(2,3). There are different techniques for the surgical repair of AAA, which are divided into two main groups: endovascular and open procedures. The endovascular procedure offers an early survival benefit, better postoperative recovery, and fewer incision-related complications as it is a minimally invasive procedure. However, it requires more re-interventions, but most are mainly minor endovascular procedures. In contrast, an open approach has a better 15-year late survival benefit, associated with greater graft durability, a lower rate of re-interventions, and the additional advantage of being more affordable (4-7). Several risk factors have been established around surgical procedures that may affect the outcome, including preoperative and intraoperative hypotension. Preoperative hypotension is one of the most crucial factors, especially when talking about ruptured AAA, where it is present with a high frequency and has been seen as an association with mortality with an AOR of 3.28 (CI 1.75-5.41; P \< .001) (8). For intraoperative hypotension, a study showed that it increased the 30-day mortality after an elective open repair of AAA with an OR of 6.61 (CI 0.71-61.07; p = 0.05). Also, it has been associated with liver dysfunction (p \< 0.001) and colonic ischemia (P=0.021) (9-11). However, the frequency and effects of postoperative hypotension in open and endovascular AAA surgery have not been described in the literature despite the everyday use of vasopressor medications (48%) in the immediate medical management following an open AAA repair(12). However, other studies have shown that postoperative hypotension in abdominal surgery is a significant complication that can have adverse effects on the patient. This condition is characterized by a decrease in blood pressure, which can lead to myocardial injury, acute kidney damage, and an increase in short-term mortality(13). According to literature, postoperative hypotension is common after major abdominal surgeries, and its detection may be suboptimal if routine vital sign assessments are the sole monitoring method. A prospective observational study found that nearly one-quarter of patients experienced episodes of mean arterial pressure (MAP) below 70 mmHg for at least 30 minutes, many of which went undetected through routine evaluations(14). Another study highlighted that prolonged postoperative hypotension, defined by absolute MAP thresholds, is associated with myocardial injury, especially when MAP falls below 65 mmHg for extended periods (15). In addition, in other vascular interventions like carotid endarterectomy, postoperative hypotension has been associated with increased risks of 30-day mortality, stroke, myocardial infarction, and length of stay(16). Given the potential implications for adverse perioperative outcomes, it is essential to elucidate potential risk factors to tailor the perioperative management of AAA repair further. Thus, we aim to describe the mortality and determine the risk factors associated with peroperative and postoperative hypotension at 48 hours in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 1-1-2013 until 31-12-2021. Research question: What were the risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 to 2021? Hypothesis: Alternate hypothesis: There are specific risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 until 2021.

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.

Targeted Abdominal CT in Conjunction With Lung Cancer Screening

Early detection through screening can improve cancer survival by identifying it when it's most treatable. The NHS now offers Lung Cancer Screening (LCS) assessments to people aged 55-74 who have ever smoked. Those at higher risk of lung cancer are offered a lung scan. This group also has a high risk of developing abdominal cancers, such as kidney cancer. A recent study explored whether it would be feasible to extend the lung scan to include the abdomen. Results showed most participants supported this addition, and the number of serious findings was similar to those detected in UK breast or bowel cancer screening programmes. However, the abdominal scan was only offered on the day of the lung scan, giving little time for people to consider their decision. The process also added too much time to be practical for widespread implementation. This new study will: * Test whether mentioning the possible abdominal scan in the initial LCS invitation affects participation in LCS assessments. * Test new processes to assess if the abdominal scan can be added to the lung scan with minimal extra time. * Check if participants can be split between the lung scan only group and lung and abdominal scan group using an approach called 'cluster randomisation'. This will be important in case a bigger trial is needed. * See whether the additional processes are acceptable People aged 55-70 who are invited to the lung cancer screening will be eligible to take part in this study. Only those who are found to be at a high risk of lung cancer after their assessment, and therefore offered a lung scan, will be offered the abdominal scan, provided they have not had an abdominal scan in the previous 12 months or one booked in the next 3 months. This study will take place in two existing lung cancer screening locations in Yorkshire.

Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair

The time between diagnosis and operative intervention represents an untapped opportunity to optimize patient readiness for surgery and augment their function prior to undergoing a physiological stress, rather than purely recovering post-operatively. Vascular surgery patients are frail and primed to benefit from such interventions and upcoming surgery is a strong motivator for behavioral change. In this proposal, the investigators outline our vision for a prehabilitation program for patients undergoing elective open aortic aneurysm repair (AAA). Participants scheduled to undergo AAA repair would receive, in addition to standard of care, 5 main interventions: exercise therapy; smoking cessation counseling and pharmacotherapy; nutritional counseling; psychological readiness planning and patient education. Exercise therapy will consist of 6 weeks of moderate exercise coordinated remotely through the cardiology rehabilitation program, whereas all other interventions will be consultations through videoconferencing or phone interactions. Outcomes of interest include morbidity, mortality, predictors of completion of program, exercise function and quality of life. This study is a pilot feasibility project and the first step in the creation of a long-term program that will improve patient clinical outcomes, exercise capacity quality of life and hopefully become an model for prehabilitation for other institutions across the country and raise the standard of care for vascular surgery patients.

Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence

The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.