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Aneurysm clinical trials

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NCT ID: NCT04589585 Recruiting - Clinical trials for Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion

Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System

Start date: June 10, 2019
Phase: N/A
Study type: Interventional

The objective of the proposed investigation is to assess the safety and effectiveness of the Merlin's DiVeRt system for the treatment of intracranial lesions. Merlin is a manufacturer of Flow- Diverters (FD) for Neurovascular applications. The technology is based on a microporous polymer membrane which is delivered to the site of lesion treatment using a metal stent scaffold. The first device in its FD family is the XCalibur Aneurysm Occlusion Device (AOD) system, which is delivered on a rapid-exchange balloon catheter which goes in a 6-Fr guide-catheter. The AOD is CE-marked and has been involved in the treatment of over 70 clinical lesion/aneurysm cases. The same technology is now being made available in a self-expandable stent platform delivered on a 0.028" microcatheter. Merlin has performed the required in-silico, in-vitro and in-vivo tests to be confident of the device performance and now intends to proceed to the human clinical-trials. DiVeRt (Interventional) is a non CE mark device. The device is under clinical trial phase. The competent authority submission for the study has been completed in Spain, Turkey and Hungary.

NCT ID: NCT04586452 Recruiting - Clinical trials for Abdominal Aortic Aneurysm (AAA)

NIH CCR2 AAA Study

Start date: February 17, 2021
Phase: Early Phase 1
Study type: Interventional

Abdominal aortic aneurysm (AAA) is a degenerative vascular disease, which is typically asymptomatic until rupture, resulting in high mortality. AAAs are more prevalent in men over age 65, though rupture is disproportionately higher in women. Due to nonlinear and unpredictable aortic dilatation, it is challenging to predict the AAA rupture using clinical diagnostics based on morphology. No medical therapy is used clinically to treat AAA, and there is an unmet need for clinically translatable, molecular biomarkers of AAA disease activity for surveillance and patient-specific management. The goal of this proposal is to develop a new approach for the diagnosis and targeted therapy of AAA.

NCT ID: NCT04583163 Recruiting - Stroke Clinical Trials

Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients

Start date: September 22, 2020
Phase:
Study type: Observational

This study aims to determine the inter- and intra-variability of Transcranial Doppler (TCD) ultrasound in neuro-critical care patients who are planned for consecutive daily TCD evaluations.

NCT ID: NCT04579081 Withdrawn - Clinical trials for Intracranial Aneurysm

Post Market Clinical Follow-up (PMCF)Study of the Contour Neurovascular SystemTM

Start date: December 2021
Phase:
Study type: Observational

Cerus Endovascular is sponsoring a prospective, multi-center PMCF to document the safety and performance of the Contour Neurovascular System™ (hereinafter "Contour") in normal medical use.

NCT ID: NCT04578808 Recruiting - Clinical trials for Unruptured Intracranial Aneurysm

Unruptured Cerebral Aneurysm: Prediction of Evolution

U-CAN
Start date: August 19, 2019
Phase:
Study type: Observational

The protocol has many assets. A prospective nationwide recruitment allows for the inclusion of a large cohort of patients with UIA. It will combine accurate clinical phenotyping and comprehensive imaging with CAWE screening. Besides, it will enable to exploit metadata and to explore new pathophysiological pathways of interest by crossing clinical, genetic, biological, and imaging information.

NCT ID: NCT04577716 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride

PET-EVAR
Start date: April 1, 2021
Phase:
Study type: Observational

The purpose of the study is to describe Sodium Fluoride uptake (using Positron Emission Tomography-Computed Tomography - PET-CT) following Endovascular Aneurysm Repair (EVAR) and to determine whether Sodium Fluoride PET-CT can predict the development of endoleaks.

NCT ID: NCT04572230 Active, not recruiting - Clinical trials for Intracranial Aneurysm

International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

IMPACT
Start date: December 21, 2020
Phase:
Study type: Observational

IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.

NCT ID: NCT04569864 Completed - Aortic Aneurysm Clinical Trials

Mild vs Moderate Hypothermic Circulatory Arrest With Unilateral Anterograde Cerebral Perfusion in Hemiarch Replacement

Start date: November 6, 2020
Phase: N/A
Study type: Interventional

The aim of our study is to analyze the immediate and long-term results between patients undergoing hemiarch replacement with ACP under mild hypothermic (30-32 °C) circulatory arrest versus moderate hypothermic (26-28 °C) circulatory arrest. It is hypothesized that circulatory arrest using mild hypothermia (30-32°C) and uSACP will result in complications reduction, during aortic hemiarch replacement, when compared to moderate hypothermia (26-28°C) and uSACP. For this purpose all of the patient population will be randomized into 2 groups. The first group of the patients during aortic hemiarch replacement, mild hypothermia (30-32°C) will be used during circulatory arrest. The second group of the patients during aortic hemiarch replacement, moderate hypothermia (26-28°C) will be used during circulatory arrest.

NCT ID: NCT04566263 Completed - Clinical trials for Intracranial Aneurysms

Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization

Start date: February 28, 2017
Phase: N/A
Study type: Interventional

This device was designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm because of the wide opening at the base of the aneurysm. This device was designed to treat aneurysms that are: unruptured, wide-necked, intracranial, saccular aneurysms arising from a parent vessel ≥ 2 mm and ≤ 4.5 mm. Wide-necked was defined as having a neck > 4mm or dome-to-neck ratio < 2.

NCT ID: NCT04564560 Completed - Aorta Aneurysm Clinical Trials

Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®

Start date: September 22, 2020
Phase:
Study type: Observational

The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.