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Cerebral Aneurysm clinical trials

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NCT ID: NCT04963933 Completed - Cerebral Aneurysm Clinical Trials

A Medical Device to Treat Brain Aneurysms

Start date: March 17, 2021
Phase: N/A
Study type: Interventional

An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms. The study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.

NCT ID: NCT03888014 Completed - Brain Tumor Clinical Trials

Intraoperative Fluorescence With Augmented Reality

Start date: July 1, 2019
Phase:
Study type: Observational

This is a study looking at a new way to evaluate vascular problems or tumors in brain surgery patients using a standard & approved intravenous dye and augmented reality.

NCT ID: NCT03288519 Completed - Clinical trials for Hemodynamic Instability

Use of Classic LMA During Endovascular Therapy

Start date: April 1, 2015
Phase:
Study type: Observational

Background: Earlier treatment and resolution for patients with cerebral aneurysms is now possible due to earlier diagnosis. This observational study aims to evaluate the intraoperative cardiovascular parameters in patients with cerebral aneurysms undergoing endovascular therapy. Method: This is an observational prospective study. Patients ≥ 18 years old diagnosed with an unruptured cerebral aneurysm or subarachnoid hemorrhage (SAH) (Hunt & Hess grade I or II) undergoing endovascular treatment under general anesthesia between April 2015 and February 2017 were included. Non-invasive measurements of hemodynamic variables were collected at six time points during the procedure (T1 to T6). Statistical analysis was performed by using central tendency measures for quantitative variables and absolute / relative frequency measurements for qualitative variables.

NCT ID: NCT03152201 Completed - Cerebral Aneurysm Clinical Trials

New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms

Start date: May 3, 2017
Phase:
Study type: Observational

During surgery, electrophysiological signals will be acquired with the instrument (ISIS IOM, NeuroExplore, Software Version 4.4, Inomed) already in use at the Neurosurgery Service of the Neurocentro of the Hospital Civic Italian Switzerland in Lugano. Simultaneously to Somatosensorial Evoked Potential (SEP) will also be recorded the Electroencephalography (EEG) activity with the same detection of locations. For the purposes of the study the signals transmitted to the neurosurgeon through the hardware and the corresponding assessments done by the neurophysiologist responsible for intraoperative monitoring will be recorded. It will also be kept track of procedures performed during surgery.

NCT ID: NCT03145701 Completed - Aneurysm Clinical Trials

Doppler Flow Wires in Cerebral Angiography

Start date: June 1, 2020
Phase:
Study type: Observational

The purpose of this study is to use a wire with a Doppler tip to measure blood flow in vessels in the brain and determine hemodynamic factors associated with treatment success or failure. Many neurological diseases cause abnormal blood flow in the brain in specific vessels. The special wire used in this study is place into brain blood vessels during standard of care procedure to treat such diseases, and blood flow parameters (such as velocity and pressure) are measured to gain better understanding of these neurological diseases.

NCT ID: NCT02700607 Completed - Cerebral Aneurysm Clinical Trials

Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity

Start date: June 2016
Phase: N/A
Study type: Interventional

After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing interventional cerebral aneurysm coiling procedure are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=10) and Group-HES (n=10). All recruited patients will be given patient identification number (PIN) for the present study of 01-20 according to their order of interview and recruitment. Investigators will prepare 10 yellow and 10 green cards, which will be inserted in 20 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 20 (Envelop number). After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department. According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture. Patient data and statistical analyses: Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge. All statistical analyses will be performed after the 20th patient's discharge and data acquisition

NCT ID: NCT02675205 Completed - Cerebral Aneurysm Clinical Trials

Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

TIC-TAC
Start date: December 2015
Phase: Phase 3
Study type: Interventional

Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. It could be an option for APT due to more reproducible response with less interindividual variability and reduced monitoring. The aim of this study is to demonstrate the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.

NCT ID: NCT02507999 Completed - Cerebral Aneurysm Clinical Trials

Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients

Start date: November 2015
Phase: N/A
Study type: Interventional

Goal directed therapy (GDT) is a technique, which employs a non-invasive cardiac output monitoring (NICOM) device to guide management of circulating blood volume and blood pressure during procedures. The purpose of this study is to determine whether the use of goal-directed therapy to optimize blood volume and cardiac output during the procedure can improve the outcome of patients undergoing endovascular treatment of a brain aneurysm.

NCT ID: NCT02455440 Completed - Cerebral Aneurysm Clinical Trials

Esmolol Infusion in Patients Undergoing Craniotomy

Start date: March 2014
Phase: Phase 3
Study type: Interventional

Anesthesia techniques that minimize anesthetic requirements and their effects may be beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in blunting adrenergic response to several perioperative stimuli and so it might interfere in the effect of the anesthetic drugs on the brain. This study was designed to investigate the effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing craniotomy.

NCT ID: NCT01943591 Completed - Cerebral Aneurysm Clinical Trials

DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial

DELTA
Start date: November 13, 2013
Phase: N/A
Study type: Interventional

Endovascular treatment with platinum coils is safe and effective in preventing rebleeding of intracranial aneurysms. Unfortunately, endovascular treatment of aneurysms with coils has been associated with incomplete occlusion at initial treatment (remnant) or at follow-up (recurrence). This in some studies has been as high as 20%. While many such aneurysm remnants or recurrences exhibit benign behavior, many require retreatment to prevent future hemorrhage. A recent randomized controlled trial of aneurysm coiling revealed that aneurysms between 2 and 9.9 mm diameter were more likely to have an improved angiographic and composite clinical outcome when treated with hydrogel-coated coils, an improvement inferred to result from higher packing density afforded by hydrogel expansion(1). The use of hydrogel coils is associated with technical difficulties related to expansion and limited time for deployment. The investigators theorize that similar results could be achieved by using more voluminous bare platinum coils, leading to improved packing density compared to smaller caliber coils, and thus result in lower incidence of remnants or residuals. The relationship between packing densities and composite clinical endpoints having never been shown in a robust fashion, the investigators therefore propose a randomized clinical trial opposing coiling with soft 15-caliber coils to 10-caliber bare platinum coils in aneurysms varying in size from 3 to 9.9 mm. To test the hypothesis that 15-caliber coiling systems are superior to standard 10-caliber coils in achieving better composite outcomes, the investigators propose the DELTA trial: Does Embolization with Larger coils lead to better Treatment of Aneurysms trial, a randomized controlled blinded trial with 2 subgroups of 282 patients each, 564 total: Subgroup 1: Coiled with a maximum proportion of 15-caliber coils as conditions allow Subgroup 2: Coiled with 10-caliber coils.