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Aneurysm clinical trials

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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: NCT04909190 Completed - Stroke Clinical Trials

Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System

SAFRANE
Start date: June 10, 2021
Phase: N/A
Study type: Interventional

Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.

NCT ID: NCT04907240 Recruiting - Clinical trials for Peripheral Artery Disease

Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

Start date: October 9, 2021
Phase:
Study type: Observational [Patient Registry]

Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

NCT ID: NCT04905303 Withdrawn - Wide Neck Aneurysm Clinical Trials

Solitaire Aneurysm Remodeling Registry

Start date: February 2009
Phase:
Study type: Observational

The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.

NCT ID: NCT04905225 Completed - Clinical trials for Ascending Aortic Aneurysm

The Gender Specific Effect on the Results of Ascending Aortic Replacement

Start date: January 1, 2013
Phase:
Study type: Observational

The aim of our study is to analyze the early and late results in men and women who underwent ascending aortic replacement in antegrade cerebral perfusion (ACP) with mild-to-moderate hypothermic circulatory arrest. Female gender is associated with poorer outcomes after surgical aorta replacement. Data on gender specific differences after ascending aortic replacement are conflicting.

NCT ID: NCT04901091 Completed - Clinical trials for Myocardial Infarction

Study of the Immediate and Long-term Outcomes of the Disease in Patients With Left Ventricular Aneurysm Complicated and Uncomplicated by Thrombosis After Transmural Myocardial Infarction, According to the Hospital Registry: SIBYL

SIBYL
Start date: January 1, 2021
Phase:
Study type: Observational

A prospective non-interventional study aimed to evaluate the immediate and long-term outcomes in patients with left ventricular aneurysm after transmural myocardial infarction. A registry of patients with transmural myocardial infarction admitted to the Emergency Department of Cardiology will be created. The registry will include all consecutive hospitalized patients from from January 1, 2021 to December 31, 2021 who meet the inclusion criteria Based on this registry, patients will be divided into groups : patients with left ventricular aneurysm and patients without aneurysm, patients with left ventricular thrombosis and patients without thrombosis. Patients will be contacted in 3 and 12 months. Surviving patients will be invited to appointment for an ECG, echocardiography and survey. The cardiovascular events during this period will be recorded. The factors determining the prognosis of patients and their concomitant diseases, immediate and long-term prognoses, therapeutic measures and drug therapy at the hospital and outpatient stages, and patients ' adherence to therapy will be analyzed.

NCT ID: NCT04894864 Recruiting - Postoperative Pain Clinical Trials

Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair

Start date: October 8, 2020
Phase: Phase 4
Study type: Interventional

Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.

NCT ID: NCT04886505 Withdrawn - Clinical trials for Aneurysm, Intracranial

An EFS Assessing the Electrolytic eCLIPs System for Treatment of Intracranial Aneurysms

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

The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms. The eCLIPs device is a novel shield like implant that is placed across the neck of the aneurysm and not only facilitates coil retention but also partly obstructs the flow of blood into the aneurysm. This is an early feasibility study, which is a small study investigating an innovative device to gather more clinical data before conducting a larger study. The safety and the effects of the device on the aneurysm will be studied for 12 months after the procedure among 15 patients at approximately 4 participating hospital centers. A larger study will be required to determine the safety and efficacy of the eCLIPs device for the treatment of wide-necked bifurcation aneurysms.

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: NCT04875429 Recruiting - Clinical trials for Aortic Aneurysm, Abdominal

Zenith® Fenestrated+ Clinical Study

Start date: December 8, 2023
Phase: N/A
Study type: Interventional

The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.