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Aneurysm clinical trials

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NCT ID: NCT05716360 Recruiting - Clinical trials for Early Susceptibility-Weighted Imaging and Vessel-Wall Imaging Findings After Flow-Diversion Treatment of Intracranial Aneurysms

Early Postprocedural Susceptibility-Weighted Imaging and Vessel-Wall Imaging For Prediction of Complications After Flow-Diversion Treatment

Start date: April 28, 2022
Phase:
Study type: Observational

Purpose: Examination of microangiopathic changes that may develop after flow-directed stenting of intracranial aneurysms with susceptibility-weighted imaging (SWI), and vessel wall imaging (VWI) of vessel wall inflammation that may be associated with stenosis in the stented vessel and rupture of the aneurysm. Methods: SWI and VWI examinations will be performed before and after treatment in patients who are planned for flow-directing aneurysm treatment. Clinical follow-up of the cases will be performed during the first 3 months post-procedure. At the end of the 3rd month, SAG and DDG findings related to and unrelated to intracranial hemorrhage will be detected by control imaging.

NCT ID: NCT05713825 Recruiting - Cerebral Aneurysm Clinical Trials

Multidimensional Evaluation of Patients With Ruptured or Unruptured Cerebral Aneurysm Undergoing Endovascular or Surgical Treatment

Start date: January 31, 2023
Phase:
Study type: Observational [Patient Registry]

Cerebral aneurysms are common changes in intracranial angioarchitecture. Unruptured aneurysms are increasingly identified thanks to the imaging techniques used in daily clinical practice. Since bleeding remains a highly dramatic event burdened by significant morbidity-mortality (about 50%), endovascular therapy, in combination with classic surgical therapy, is an essential element in contemporary medicine. Endovascular and surgical treatment represent the standard of care. The rationale of this study is to identify clinical and radiological characteristics, mainly neuro-radiological ones, not fully explored in previous studies, which can help predict the outcome of patients affected by cerebral aneurysm. The study will have the characteristics of a retrospective study on patients with cerebral aneurysm treated at our center from 1 January 2015 to 31 December 2023. Objective of the study is the multidimensional evaluation in patients with cerebral aneurysms, ruptured and unruptured, undergoing an endovascular embolization procedure or surgical treatment.

NCT ID: NCT05708118 Recruiting - Heart Diseases Clinical Trials

Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.

ARDITAV
Start date: January 20, 2023
Phase:
Study type: Observational

The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients who underwent elective aortic valve replacement or TAVR for stenotic bicuspid aortic valve (BAV) at our institution from 2015 to June 2022. Participants will undergo both a CT and an echocardiographic assessment at least 90 days after surgery.

NCT ID: NCT05703893 Recruiting - Rare Diseases Clinical Trials

Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)

IPaNeMA
Start date: November 9, 2021
Phase:
Study type: Observational

The goal of this observational cross-sectional study is to learn about vagal features in patients with syndromic and non-syndromic TAA. The main question it aims to answer is to highlight a functional condition that could help stratify patients with TAA on the risk of aortic complications. Participant will take part by standing in supine position for 10 minutes and during active standing for 10 minutes. In this period of time, it will be possible to acquire the signals continuously and non invasively through recorded non-invasive blood pressure and piezoelectric sensor breathing belt.

NCT ID: NCT05665101 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)

EVAR-SE
Start date: January 15, 2023
Phase: N/A
Study type: Interventional

Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture. Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.

NCT ID: NCT05660733 Recruiting - Clinical trials for Prosthetic Infection

Study of the Aortic and Large Arterial Vessel Infections

Repia
Start date: June 30, 2023
Phase:
Study type: Observational [Patient Registry]

Aortic or large arterial vessel infections are rare but serious infections. Their management is based on French and American expert opinions. The quality of evidence supporting these guidelines is low because most publications on the subject correspond to case series and few interventional studies have been performed to validate their management. However, referral centres for vascular surgery are frequently solicited to give their opinion on patients suffering from mycotic aneurysms. In addition, the last few decades have seen the improvement of vascular surgery techniques allowing the management of more and more patients, often elderly and comorbid. There has therefore been an increase in the incidence of infectious complications associated with this care. It is therefore essential to participate in research on aortic and large arterial vessel infections. For this, a monocentric cohort study seems to be an essential first step to better understand the polymorphism and complexity of these patients.

NCT ID: NCT05651425 Recruiting - Clinical trials for Intracranial Aneurysm

A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment

Start date: December 20, 2022
Phase:
Study type: Observational

the goal of this clinical trail is to evaluate the efficiency and safety of intracranial aneurysm assistive software in the preoperative assessment. The trail is designed as retrospective, multicenter, controlled clinical trail. Collecting probable cases images retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling bias strictly, to make sure the efficiency and safety of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, software-assisstant planning controls against experienced-surgeon-independent planning,which aims to avoid bias effictively and eliminate non-test interferences.

NCT ID: NCT05639400 Recruiting - Aortic Aneurysm Clinical Trials

Thoraflex Hybrid and Relay Extension Post-Approval Study

EXTEND
Start date: March 17, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05636124 Recruiting - Clinical trials for Intracranial Aneurysms

Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

CLASS
Start date: June 2, 2023
Phase: N/A
Study type: Interventional

This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.

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).