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Aneurysm, Cerebral clinical trials

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NCT ID: NCT06215105 Enrolling by invitation - Aneurysm Cerebral Clinical Trials

Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices

CAR
Start date: January 8, 2024
Phase:
Study type: Observational [Patient Registry]

To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of the treating physician.

NCT ID: NCT06123325 Recruiting - Clinical trials for Mental Health Wellness 1

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

POUIA
Start date: December 1, 2023
Phase:
Study type: Observational

The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.

NCT ID: NCT06033378 Recruiting - Blood Pressure Clinical Trials

Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.

BFBP
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.

NCT ID: NCT05563051 Recruiting - Aneurysm Cerebral Clinical Trials

Kaneka Endovascular Embolization and Protection

KEEP
Start date: December 13, 2022
Phase: N/A
Study type: Interventional

Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

NCT ID: NCT05441618 Enrolling by invitation - Trauma, Brain Clinical Trials

Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®

LYOPLACE
Start date: April 2, 2024
Phase:
Study type: Observational

Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.

NCT ID: NCT05419661 Not yet recruiting - Aneurysm Cerebral Clinical Trials

Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms

Anev3D
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

It is now considered that 1% to 2% of the French population has an intracranial aneurysm. The major risk of this malformation is essentially the rupture which will lead in 10% of cases to death immediately, in 30% to 50% death within three weeks and in 30% of cases the patients will present a permanent disability. The management of this pathology represents today a major health challenge. Historically, neurosurgery was the discipline of first choice for the treatment of this pathology. This consists of clipping the aneurysm by a surgical approach to exclude it from the blood circulation and thus avoid its rupture. For many years now, interventional neuroradiology has established itself, through its "minimally invasive" and endovascular approach, as the reference treatment for ruptured and non-ruptured intracranial aneurysms: this is embolization. This so-called minimally invasive technique consists of placing directly into the aneurysm, using micro-catheters that are navigated under radiological control from the femoral artery, turns of plates called "coils" or prostheses called " stent" or "flow-diverter". This technique makes it possible to secure the aneurysm from the inside and thus reduce the risk of rupture. Today, 95% of patients are treated using this innovative technique and limited intraoperative risks. Interventional neuroradiology has constantly known in recent years a set of revolutions and innovations in terms of implantable medical devices (IMD) allowing to treat more and more patients with excellent clinical results. Today, the interventional neuroradiologist, assisted by the radiographer, has a very wide range of IMDs that he can combine with each other depending on the type, location, size and shape of the aneurysm. The role of the manipulator, here, is to work closely with the neuroradiologist so that he has, on the one hand, quality images and on the other hand, that he can count on a precious ally, an expert in IMDs, during embolization procedures. However, the wide choice of medical devices and the complexity of the aneurysms to be treated sometimes make treatment complicated. On the day of the "cold" treatment of the aneurysm (i.e. non-ruptured), the technicality of the catheterization and aneurysm's spatial conformation complicates the deployment of embolization equipment. This then sometimes leads to undesirable events such as intraoperative rupture. The very purpose of this study is to be able, by means of a 3D printer, to print the patient's aneurysm from the segmented 3D images obtained during the initial assessment and thus proceed to a simulation of the embolization procedure. This pre-operative planning (PPO) carried out in real conditions aims to anticipate the possible complications that could be encountered on the same day of treatment.

NCT ID: NCT05324605 Recruiting - Aneurysm Cerebral Clinical Trials

Personalized Treatment Planning in Intracranial Aneurysm Surgeries.

3 D
Start date: January 1, 2021
Phase:
Study type: Observational

Patients who will undergo a intracranial aneurysm (IA) surgery are educated concerning their disease and the surgical procedure.The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

NCT ID: NCT05257824 Recruiting - Clinical trials for Endovascular Procedures

Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

Start date: June 23, 2022
Phase: Phase 4
Study type: Interventional

Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms

NCT ID: NCT05029947 Recruiting - Aneurysm Clinical Trials

Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms

Start date: January 1, 2016
Phase:
Study type: Observational

To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following microsurgical clipping of unruptured intracranial aneurysms (UIA).

NCT ID: NCT03823482 Enrolling by invitation - Aneurysm, Cerebral Clinical Trials

Lidocaine and Perioperative Cytokine Levels in Blood and Cerebrospinal Fluid in Cerebral Aneurysm Patients

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Cerebral aneurysm surgery has significant mortality and morbidity rate. Inflammation plays a key role in the pathogenesis of intracranial aneurysms, their rupture, subarachnoid haemorrhage and neurologic complications. Brain injury activates immune cells and triggers cytokine release. Cytokine level in blood and cerebrospinal fluid is an indicator of inflammatory response. Cytokines contribute to secondary brain injury and can worsen the outcome of the treatment. Preventing secondary brain injury by modulating inflammatory response represents a therapeutic target. Lidocaine is local anesthetic that can be used in neurosurgery for regional anesthesia of the scalp and for topical anesthesia of the throat prior to direct laryngoscopy and endotracheal intubation. Except analgetic, lidocaine has systemic anti-inflammatory and neuroprotective effect. It acts through several mechanisms on various types of immune cells producing immunosuppressing effect. Lidocaine can act on activated microglia within central nervous system causing attenuation of immune response. Primary aim of this prospective randomized trial is to determine influence of lidocaine administration on inflammatory cytokine levels in serum and cerebrospinal fluid during and following cerebral aneurysm surgery. Secondary aim is to determine possible correlation between levels of cytokines and incidence of neurologic and infectious postoperative complications. For that purpose, postoperative neurological clinical status will be recorded. Signs of vasospasm and pathological postoperative brain CT scan findings will be recorded. Incidence of meningitis, pneumonia and sepsis in postoperative period will also be analyzed. Hypothesis of this trial is that lidocaine administration during cerebral aneurysm surgery would significantly change levels of pro-inflammatory cytokines in cerebrospinal fluid and serum. Lower concentrations of pro-inflammatory cytokines can possibly contribute to better outcome and significantly lower incidence of postoperative complications. Enzyme-immunochemical analysis will be used to measure levels of interleukin-1β, interleukin-6 and tumor necrosis factor-α in cerebrospinal fluid and serum. Investigation group will have, during cerebrovascular surgery under general anesthesia, regional anesthesia of the scalp and topical anesthesia of the throat prior to laryngoscopy, all done with lidocaine. Control group will have general anesthesia without lidocaine administration.