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Aortic Aneurysm, Abdominal clinical trials

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NCT ID: NCT03608683 Completed - Clinical trials for Proximal Abdominal Aortic Aneurysms

Evaluation of the Treatment of Abdominal Aortic Pathology With Hostile Necks, Para-/Juxra-renal and Sovrarenal Pathology at Short, Mid and Long Term

p-AAA
Start date: July 4, 2018
Phase:
Study type: Observational

Although open repair (OR) is currently reported as the gold standard of treatment, fenestrated endovascular repair (FEVAR) is being increasingly applied for the treatment of proximal abdominal aortic aneurysms (p-AAA) such as hostile-necked, juxta-, para- and supra-renal aortic aneurysms.1 Nevertheless, advantages of FEVAR in terms of lowering postoperative complications, should be balanced with the need of both complex device configurations and operators with large endovascular expertise. The aim of this study is to report the experience of Data from patients treated will be prospectively collected. All post-operative results will be recorded. Major adverse event (MAE) are defined as the presence of one of the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, respiratory failure, stroke and renal insufficiency. Furthermore, the pre-operative contrast-enhanced computed tomography scans (CTA) of all patients, stored in the hospital PACS, will be analyzed on the dedicated workstation with OsiriX software (Pixmeo sarl, Bernex, Switzerland) currently employed in our Unit for imaging assessment. Patients will undergo standard control with the execution of a Doppler ultrasound and creatinine serum levels at 1, 6, 12, 24, 36, 48 and 60 months. A CTA will also be performed at 12 months as per standard clinical practice. of p-AAA treatment.

NCT ID: NCT03594786 Recruiting - Clinical trials for Aortic Aneurysm, Abdominal

Impact of Supra-renal Fixation of EVAR on Hemodynamics of Renal Arteries

IFIXEAR
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The investigators conducted a bicentric prospective study to quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation EVAR with suprarenal fixation immediately postoperatively.

NCT ID: NCT03512470 Completed - Clinical trials for Toraco Abdominal Aneurysm

Clinical Study on the Prevention of Surgical Wound Complications for Aneurysmal Thoracic-abdominal Aortic Pathology Using the "PREVENA" System

TVAC
Start date: April 24, 2018
Phase: N/A
Study type: Interventional

The patients will be randomized into two groups of 100 subjects each one. One arm will be randomized to treatment with a negative topical pressure system (Sistema Prevena ™); while the other arm ("control group") will be randomized to treatment with standard medication with sterile gauzes and a TNT patch or medicated patch as normal traditional medication in use. The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter the medication will be checked in the inpatient ward after 48 hours from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed. The medication will be renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery. For each evaluation the photograph of the medication must be taken (which will be deprived of all the identifying elements of the patient).

NCT ID: NCT03507413 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Metformin Therapy in Non-diabetic AAA Patients

MetAAA
Start date: September 26, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

A prospective randomized, double blind, placebo-controlled, safety and efficacy study of metformin as add-on therapy in abdominal aortic aneurysm (AAA) OBJECTIVES Primary Objective - To demonstrate treatment efficacy of metformin in AAA in comparison to placebo or active comparator, as measured by growth of the AAA maximum diameter at 12 months Secondary Objectives - To asses inflammatory cytokines and parameters of neutrophil activation in AAA in response to metformin treatment by glucose - insulin - Interleukin-6 - markers of neutrophil activation (MPO, elastase, NGAL)

NCT ID: NCT03493074 Recruiting - Clinical trials for Cardiovascular Diseases

Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA)

VBA
Start date: April 8, 2018
Phase:
Study type: Observational

This study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm (AAA) and endovascular treatment of AAA (EVAR) on arterial pulse wave

NCT ID: NCT03484013 Completed - Aneurysm Clinical Trials

Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO)

PEVAR-PRO
Start date: January 9, 2019
Phase:
Study type: Observational

Purpose of the study is the evaluation of the applicability of the percutaneous technique through double Proglide and Pre-Close Technique to the treatment of complex aortic aneurysms with thoracic endoprosthesis (TEVAR), fenestrated or branched (F / B-EVAR) in which patient-related factors, the devices used or the procedure, could affect the performance.

NCT ID: NCT03481075 Recruiting - Aortic Aneurysm Clinical Trials

Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair

AAA2D3DIII
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

This project is aiming at the integration of a biomechanical computer program with a guidance code to simulate the endovascular repair (EVAR) procedure of abdominal aortic aneurysm (AAA). The computational time associated with finite element simulation generally renders its usage impractical for real-time application. Based on data collected during clinical interventions and a priori knowledge of AAA and endovascular device mechanical modeling, the investigators are proposing a deformable registration between preoperative CT-scans and per-operative fluoroscopy that will take into account prior simulations of participant specific EVAR procedures. To avoid the computational cost of a full finite element simulation, the investigators propose a simplified and real-time compliant repetitive mechanical behaviour based on participant specific parameters. The results of this research will provide the Canadian industry with the first realistic deformable vascular geometry tool for live endovascular intervention guidance. The proposed biomechanical modeling can be translated to other vascular intervention procedure by adjusting the biomechanical parameters.

NCT ID: NCT03479164 Completed - Clinical trials for Aortic Aneurysm, Abdominal

Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms

Start date: March 30, 2016
Phase: N/A
Study type: Interventional

The primary objective of this research project is development and validation of a new, non-contrast gated aortic (NCGA) computer tomography scan algorithm for screening of aortic aneurysm in the chest and abdomen in at risk patients. This study would initially be performed in patients with a known aneurysm and done in addition to their indicated surveillance CT scan.

NCT ID: NCT03469388 Completed - Clinical trials for Infrarenal Abdominal Aortic Aneurysm

Arterial Stiffness, Blood Pressure and Cardiac Output Study

ABC
Start date: April 24, 2017
Phase: N/A
Study type: Interventional

Comparison of non-invasively obtained central blood pressure using SphygmoCor and invasively recorded central blood pressure in patients with an AAA that will be treated with EVAR.

NCT ID: NCT03469245 Completed - Clinical trials for Abdominal Aortic Aneurysms

Validation of Fenestrations Positioning by Numerical Simulation

FenSim
Start date: April 26, 2018
Phase:
Study type: Observational

Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.