Clinical Research Directory

The Role Oral Microbiome in the Development and Progression of Aorta Aneurysm and Carotid Atherosclerosis

The goal of this observational study is to compare the microbiome (bacterial al community) of the diseased vascular site and the oral cavity with specific attention to chronic inflammatory periodontitis in patients who have aorta aneurysm or carotid stenosis needing surgical treatment. The main question it aims to answer is whether pathogen members of the oral microbial community, that cause periodontal disease, are also present in the diseased vascular site proving its translocation from the oral cavity to the vascular system. We hypothesize that bacteria causing chronic periodontal disease can be found at the diseased vascular site highlighting the importance of maintaining and restoring oral health as preventive measure for vascular diseases. Participants will be asked to take part in a dental screening before vascular surgery, during which few samples will be taken non-invasively for analysis.

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.

Assess Abdominal Aortic Diameter in Females

Female subjects aged 50 years or older will be enrolled. Biometric data (measurements) of the aorta and iliac vessels, demographic data, pathophysiological history, and data relating to menarche, pregnancy/infertility, and menopause will be collected. The aortic diameter measurement protocol will follow standard clinical practice. Measurements will be performed by placing the probe on an axis perpendicular to the aortic axis, manually positioning the calipers in the antero-posterior and lateral-lateral directions, recording both the outer-to-outer (OTO) and inner-to-inner (ITI) diameters. Additionally, the presence of thrombus and/or calcifications and the outer-to-outer (OTO) measurement of the common iliac arteries will be detected. Primary objective: Definition of the ultrasound diameter of the abdominal aorta in the female population. Secondary objective: Identification of any sex-specific risk factors associated with abdominal aortic disease (aneurysm) in the female population. Secondary objective: Identification of any sex-specific risk factors associated with abdominal aortic disease (atherosclerosis) in the female population.