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Aneurysm clinical trials

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NCT ID: NCT04941157 Active, not recruiting - Clinical trials for Spinal Cord Ischemia

Prophylactic vs Therapeutic Cerebrospinal Fluid Drain Placement During Endovascular Thoracoabdominal Aortic Aneurysm Repair

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This is a pilot study to be performed at the University of Alabama at Birmingham (UAB) and the University of Massachusetts to determine the feasibility and develop the processes for a future randomized controlled trial to evaluate the occurrence of spinal cord ischemia after endovascular thoracoabdominal aneurysm repair using prophylactic cerebrospinal fluid drains versus no pre-emptive drain. The research question to be addressed is as follows: In the setting of a comprehensive spinal cord ischemia prevention protocol, do prophylactic CSF drains decrease the rate of spinal cord ischemia (SCI) in patients undergoing endovascular thoracoabdominal aneurysm repair?

NCT ID: NCT04913493 Active, not recruiting - Aortic Aneurysm Clinical Trials

Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS

Start date: June 8, 2021
Phase: N/A
Study type: Interventional

the aim of this study is to determine whether an intraoperative optimization protocol using the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in combination with intraoperative measurement of the sublingual microcirculation with the Cytocam-IDF device would result in an improvement in outcome in high-risk patients undergoing major vascular surgery, measured by the hospital LOS in comparison with intraoperative FloTrac/Vigileo monitoring alone. The FloTrac/Vigileo device only needs standard arterial access for enhanced, flow-based hemodynamic monitoring. It is reported to be easy to use and easy to set up and calculates the stroke volume (SV) on the basis of the arterial waveform in combination with demographic data. Cardiac index (CI), stroke volume index (SVI) as an indicator for fluid status and stroke volume variation (SVV) as an indicator for fluid responsiveness during mechanical ventilation and sinus rhythm will be continuously measured during major vascular procedures, including carotid endarterectomy (CEA), open abdominal aortic aneurysm (AAA) repair , endovascular aneurysm repair (EVAR), thoracic endovascular aneurysm repair (TEVAR) and fenestrated endovascular aneurysm repair (FEVAR).

NCT ID: NCT04876638 Active, not recruiting - Clinical trials for Delayed Cerebral Ischemia

Minocycline for Aneurysmal Subarachnoid Hemorrhage (MASH)

Start date: July 1, 2019
Phase: Phase 2
Study type: Interventional

Previous work has demonstrated patients presenting with ruptured aneurysms that develop radiographic and clinical vasospasm have a higher permeability of the blood brain membrane. Matrix metalloproteinase 9 (MMP9) has been studied and recently implicated in both the pathogenesis of the blood brain barrier breakdown and vasogenic edema of ischemia strokes, and is suggested to be an accurate biomarker to predict the onset of cerebral vasospasm after subarachnoid hemorrhage. The therapeutic benefit of minocycline, an MMP9 inhibitor, has been investigated in ischemic stroke population, however its role in the treatment of cerebral vasospasm from ruptured aneurysms remains unknown. Our project has two main goals: to further confirm MMP9 has a reliable biomarker for the onset of cerebral vasospasm, and secondarily to investigate any possible therapeutic benefit that minocycline has in the vasospasm population. Vasospasm continues to be one of the major contributors of morbidity and mortality in the ruptured aneurysm population, and close monitoring of the neurologic exam during the 'vasospasm window' usually requires two weeks in the intensive care unit in most academic settings. As such, if we are better able to predict which patients are at risk of developing vasospasm based on MMP9 levels, we will be better able to anticipate the need for intervention and therefore mitigate the risk of vasospasm induced ischemic strokes, ultimately resulting in better outcomes in the ruptured aneurysm population. Further, if we are able to identify minocycline as a therapeutic agent to deter, or lessen the severity of vasospasm, we can possibly improve neurologic outcomes, decrease hospital stays, ultimately providing an improved and more cost-effective treatment strategy to our patients.

NCT ID: NCT04765592 Active, not recruiting - Clinical trials for Aortic Arch Aneurysm

Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)

Start date: June 7, 2021
Phase: N/A
Study type: Interventional

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic arch aneurysms and ulcers involving aortic arch . (GIANT Study)

NCT ID: NCT04751578 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands

AAA-SHAPE_NLD
Start date: July 13, 2021
Phase: N/A
Study type: Interventional

To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.

NCT ID: NCT04676672 Active, not recruiting - Aortic Aneurysm Clinical Trials

A PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO

NEOS
Start date: December 3, 2020
Phase:
Study type: Observational [Patient Registry]

The NEOS post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of E-vita OPEN NEO in the treatment of aneurysm or dissection in the ascending aorta, aortic arch and descending thoracic aorta.

NCT ID: NCT04592185 Active, not recruiting - Vascular Diseases Clinical Trials

The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms

EPI-EFA
Start date: October 21, 2019
Phase:
Study type: Observational [Patient Registry]

The French Ministry registered the Fenestrated Anaconda ™ on the List of Reimbursable Products and Services (LPPR) by the French Health Insurance on February 2018 for a duration of 5 years, while taking up the conditions for carrying out the act recommended by the CNEDiMTS (Committee in charge of medical device review), namely the carrying out of a post-registration study for the renewal of the authorization. This renewal of registration is conditioned by the set-up of a long-term follow-up study of all patients treated with the Fenestrated Anaconda ™ in France. To do this, this study will be carried out in partnership with the Federation of Medical Specialties (FSM) and the National Professional Council (CNP) of Vascular Surgery in order to have the data necessary for the renewal of the registration of the Fenestrated Anaconda ™ from the registry called Datavasc developed by the CNP and available online on the FSM's electronic platform.

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: NCT04518670 Active, not recruiting - Clinical trials for Intracranial Aneurysm

Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)

Start date: November 24, 2020
Phase:
Study type: Observational [Patient Registry]

The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as ≥ 4 mm or a dome-to-neck ratio < 2. The objective of the Postmarket Surveillance Plan is to assess safety and performance as used in postmarket clinical practice in the U.S.