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Abdominal Aortic Aneurysm clinical trials

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NCT ID: NCT05617326 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound

DACEP
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Abdominal aortic aneurysm (AAA) is a localized dilatation of a segment of the aorta artery in its abdominal portion. It affects 1.7% of men aged 65 years and older. In the high-risk population (male smokers aged 65-75 years), its prevalence is estimated to be between 2.8 and 9%. Mortality of ruptured AAAs is high (80% of deaths before hospitalization or perioperatively), whereas mortality of scheduled procedures for unruptured AAAs is less than 5%. AAA screening has been shown to significantly reduce the specific mortality rate in the medium and long term. The French National Authority for Health (HAS) recommends targeted screening for AAA by ultrasound at the radiologist. The target population is male smokers or former smokers aged 65 to 75 years, as well as all persons aged 50 to 75 years with a family history of AAA. Despite recommendations, the rate of access to targeted screening appears low. Ultrasound screening for AAA is a rapid, noninvasive, and reproducible test. It relies primarily on the measurement of the maximum diameter of the abdominal aorta in cross-section. It has been demonstrated that the learning of the ultrasound screening procedure for AAA is very fast and that the performance of non-radiologists trained in this procedure alone is similar to that of radiologists. In addition, new ultra-portable ultrasound devices, inexpensive and with validated performances have appeared on the market in the last few years, making it possible to equip general practitioners (GPs). We propose a simplified care pathway for AAA screening, by equipping GPs with an ultra-portable ultrasound scanner and by training them to perform the screening procedure, which will be performed in the office or at the patient's home, during a usual consultation of general medicine. Our hypothesis is that this new organization will allow better access to screening for the target population, at a lower cost, compared to the current screening method recommended by the HAS (referral of the patient to the radiologist).

NCT ID: NCT05609539 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm

RESTHONE
Start date: February 1, 2023
Phase:
Study type: Observational

The goal of this multicenter, observational cohort study is to evaluates the clinical effectiveness of a single-renal scallop custom-made stent-graft (TREO, Terumo Aortic, Sunrise, FL) to treat "hostile" AAA with mismatched renal arteries as actual standard of care in this Vascular Unit The main question it aims to answer are: if a dedicated devices could improve the results in the endovascular treatment of patients suffering to infrarenal abdominal aortic aneurism with a mismatched takeoff of the renal arteries. Participants responding to inclusion criteria will be treated as best clinical practice with a custom made device with a single scallop for the renal artery. The minimum follow-up requested, as standard clinical practice, was: 3-months, 12-18 months- and 5-years CTA; clinical and DUS examination at 6- and 12- and 36-months after the intervention and yearly thereafter. No comparison group was present.

NCT ID: NCT05449509 Recruiting - Clinical trials for Coronary Artery Disease

Abdominal Aortic Aneurysm Screening Before Coronary Artery Bypass Surgery

Start date: August 15, 2022
Phase:
Study type: Observational

Coronary artery disease (CAD) and abdominal aortic aneurysm (AAA) are two separate entities with common risk factors such as hypertension, advanced age, male sex. Atherosclerosis plays an important role in the etiology of both diseases. It has been reported that AAA is more prevalent in patients undergoing coronary artery bypass grafting (CABG). Despite all the evidence, current guidelines do not recommend routine screening for AAA before CABG. Syntax score shows anatomical significance of CAD and is associated with the degree of atherosclerotic load. The investigators aim to investigate if there were any differences regarding AAA prevalence in high-SYNTAX patients versus intermediate/low-SYNTAX patients.

NCT ID: NCT05378347 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

ADVANCE
Start date: January 5, 2023
Phase: N/A
Study type: Interventional

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.

NCT ID: NCT05376514 Recruiting - Blood Pressure Clinical Trials

Central Blood Pressure and Variability Evaluation

CAVE-ON
Start date: June 7, 2022
Phase:
Study type: Observational [Patient Registry]

Background: A sub-study of the AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) trial indicated a statistically significant association between central blood pressure (BP) variability and abdominal aortic aneurysm (AAA) growth. The role of anti-hypertensive adherence has not been explored in the context of AAA growth. Objective: To confirm whether higher central BP variability is associated with higher AAA growth rates and to examine the effect of medication adherence on AAA growth rates in a prospective longitudinal cohort study. Methods: Up to 175 patients will be recruited over ten months from two sites with standardised quality control of AAA, BP and antihypertensive non-adherence measurement. Patients (>55 years), with AAAs ≥3cm in diameter (including AAA ≥5.5cm, not proceeding to surgery) will be recruited and undergo AAA ultrasound (US), BP (peripheral and central) and antihypertensive non-adherence measurements every four months (+/- one month) for 24 months. Ambulatory BP variability data will be collected. Data on medication adherence and beliefs around medications will be collected with validated questionnaires. Analysis: Primarily, the relationship between central diastolic BP visit-to-visit variability and AAA growth (estimated by multilevel modelling) based on US measurements and secondarily the relationship between central diastolic BP variability and time taken to reach the threshold for AAA repair (5.5 cm) or rupture.

NCT ID: NCT05375292 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm

EPOP-AORTA
Start date: December 6, 2022
Phase: N/A
Study type: Interventional

This is a pilot, prospective, randomized control trial that aim to provide a first estimation of the 3-month post-operative variation in the functional recovery of patients who benefited from an outpatient pre-habilitation program and patients who did not benefit from it.

NCT ID: NCT05304026 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Optimizing CO2 Injection Technique for EVAR

Start date: January 1, 2021
Phase:
Study type: Observational

Automated carbon dioxide (CO2) angiography is considered a safe diagnostic alternative to standard iodinated contrast medium (ICM) for endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA), especially in patients with preoperative renal function impairment. Recent literature experiences describe the use of automated CO2 angiography in EVAR. One of the main issues of CO2 angiography is the inability to detect the origin of the lowest renal artery (proximal neck visualization) that was estimated up to 38%. In these experiences, the CO2 automated angiography is usually performed by a 5F pigtail catheter placed at renal arteries level. The aim of the study is to evaluate the efficacy of a new automated CO2 injection technique by a 5F introducer (single hole catheter) positioned at the distal level of the proximal neck in detecting both renal arteries in the first diagnostic and completion angiographies.

NCT ID: NCT05234892 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

ALTo endogrAft Italian Registry

ALTAIR
Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

The aim of present study is to evaluate intraoperative, peri-operative, and post-operative results in patients treated by the ALTO stent graft (Endologix Inc. Irvine, Calif) for elective Abdominal Aortic Aneurysm repair in a multicentric consecutive experience.

NCT ID: NCT05183373 Recruiting - Coronary Disease Clinical Trials

Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

CARE-ANUERYSM
Start date: January 10, 2022
Phase:
Study type: Observational

The main objective of the CARE-ANEURYSM project is to evaluate inflammation and clotting abnormalities in patients with aneurysmal coronary artery disease in relation to patients with abdominal aortic aneurysm or coronary artery disease (acting as controls).

NCT ID: NCT05172830 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Hellenic Registry of Ovation Alto™ Abdominal Stent Graft System

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.