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Aneurysm clinical trials

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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: 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.

NCT ID: NCT04870047 Recruiting - Clinical trials for Intracranial Aneurysm

Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

COATING
Start date: September 3, 2021
Phase: N/A
Study type: Interventional

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.

NCT ID: NCT04865718 Recruiting - Aneurysm, Brain Clinical Trials

Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

Start date: June 27, 2019
Phase:
Study type: Observational

The purpose of this research study is to evaluate the ability of laser speckle contrast imaging to visualize blood flow in real time during neurosurgery. Real-time blood flow visualization during surgery could help neurosurgeons better understand the consequences of vascular occlusion events during surgery, recognize potential adverse complications, and thus prompt timely intervention to reduce the risk of stroke. The current standard for visualizing cerebral blood flow during surgery is indocyanine green angiography (ICGA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Unfortunately, ICGA can only be used a few times during a surgery due to the need to inject a fluorescent dye, and provides only an instantaneous view of perfusion rather than a continuous view. Laser speckle contrast imaging does not require any dyes or tissue contact and has the potential to provide complementary information to ICGA. In this study we plant to collect blood flow images with laser speckle contrast imaging and to compare the images with ICGA that is performed as part of routine care during neurovascular surgical procedures such as aneurysm clipping.

NCT ID: NCT04852783 Recruiting - Clinical trials for Aneurysm, Intracranial

US IDE Study of the Contour NEurovasCular Systemâ„¢ for IntraCranial Aneurysm Repair

NECC
Start date: August 6, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device.

NCT ID: NCT04839705 Recruiting - Clinical trials for Wide Neck Bifurcation Intracranial Aneurysms

Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device

WEB PAS
Start date: August 24, 2022
Phase: N/A
Study type: Interventional

A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

NCT ID: NCT04819074 Recruiting - Aneurysm, Brain Clinical Trials

Prediction of Outcomes After Surgery for Unruptured Intracranial Aneurysms

PRAEMIUM
Start date: May 20, 2021
Phase:
Study type: Observational

Accurate preoperative identification of patients at high risk for adverse outcomes would be clinically advantageous, as it would allow enhanced resource preparation, better surgical decision-making, enhanced patient education and informed consent, and potentially even modification of certain modifiable risk factors. The aim of the Prediction of adverse events after microsurgery for intracranial unruptured aneurysms (PRAEMIUM) study is therefore to develop and externally validate a clinically applicable, robust ML-based prediction tool based on multicenter data from a range of international centers.

NCT ID: NCT04814238 Recruiting - Clinical trials for Aortic Aneurysm, Thoracic

Minimally Invasive Aortic Root and Aorta surGery rEgistry

MIRAGE
Start date: March 22, 2021
Phase:
Study type: Observational [Patient Registry]

Minimally invasive aortic valve (AV) surgery has become widely accepted alternative to standard sternotomy. Despite possible reduction in morbidity, this approach is not routinely performed for aortic surgery. Evidence exists, however, on safety of this approach together with promising results regarding its long-term durability. The MIRAGE Registry is aimed to collect and analyse the data from multiple aortic excellence centres and to analyse them in numerous clinical scenarios.

NCT ID: NCT04811222 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

DOTATATE PETMRI AAA Study

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Abdominal Aortic Aneurysm (AAA) screening and an aging population have increased the prevalence of AAA diagnoses. Small AAAs (<5.5cm) are monitored with ultrasound. Large AAAs may rupture and this is usually fatal. Surgery is considered at a crude size threshold of 5.5cm when the annual rupture risk reaches 5%. AAA size is the only predictor of growth and rupture available but growth is non-linear and some small AAAs rupture. Thus, only 1 in 20 patients treated at 5.5cm will have benefited from rupture prevention in the year following surgery, and others may miss out on life-saving surgery. This study will develop an imaging tool PETMRI with radiotracer Ga- DOTATATE with high clinical utility, to improve prediction of aneurysm growth and risk.

NCT ID: NCT04799964 Recruiting - Clinical trials for Intracranial Aneurysm

Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

Start date: August 12, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.