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Aneurysm clinical trials

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NCT ID: NCT06416657 Not yet recruiting - Clinical trials for Intracranial Aneurysm

General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter

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

The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement.

NCT ID: NCT06412783 Completed - Clinical trials for Intracranial Aneurysm

Population-based Investigation of Aneurysm Incidence

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

Most intracranial aneurysms are found accidentally in neurovascular imaging. And these inspection methods are limited by the problems of instrument fixation, radiation, time-consuming, contrast agent toxicity and so on. At present, blood test is an ideal alternative method for early diagnosis. Compared with imaging examination, it is economical, general screening and convenient. Blood test is simple to operate, easy to be accepted by patients, and less invasive. Early screening of aneurysms can be performed.

NCT ID: NCT06411990 Not yet recruiting - Aortic Aneurysm Clinical Trials

Laser In Situ Fenestration Study

LIFE
Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about a new device, named the LIFE device, to treat people with aneurysms (swellings) in the aorta (large, main blood vessel that delivers blood from the heart to the body). The main questions this trial aims to answer are: - If the LIFE device works to treat aortic aneurysms - What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years have their pulses checked, bloodwork to check kidney function (BUN and serum creatinine), and a CT scan of the aneurysm area.

NCT ID: NCT06411418 Recruiting - Clinical trials for Intracranial Aneurysms

Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm

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

The Jacobs Institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms

NCT ID: NCT06405971 Not yet recruiting - Clinical trials for Dissecting Aneurysm of Cerebral Artery

Metformin in Patients With Unruptured Vertebrobasilar Dissecting Aneurysms (METTLE)

METTLE
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Vertebrobasilar dissecting aneurysms (VBDAs) are one of the most important causes of stroke in young and middle-aged people, and the natural history of VBDAs is complex and varied, often leading to high rates of disability and mortality. For some patients with VBDAs who are not suitable for surgical entrapment and intervention, pharmacologic therapy may be used to slow the progression of VBDAs. Metformin (MET) has been shown to act as an anti-inflammatory, anti-oxidative stress and improve vascular endothelial function by inhibiting smooth muscle cell phenotypic transformation, proliferation, migration and apoptosis, thereby reducing the incidence of intracranial aneurysms and rupture rates, and MET may be a suitable candidate. Inflammatory response plays an important role in the occurrence, development and rupture of VBDAs. Inflammatory response in the aneurysm wall can cause endothelial and smooth muscle cell injury and apoptosis, leading to degenerative changes in the vessel wall and increasing the risk of rupture of VBDAs. High-resolution magnetic resonance vessel wall imaging (HR-VWI), which can clearly show the structure of the vessel wall and reflect the active degree of inflammatory reaction in the aneurysm wall, has been widely used in the assessment of intracranial aneurysm instability. In this study, we propose to conduct a multicenter, prospective, randomized study to investigate whether MET reduces the degree of aneurysm wall inflammatory response in VBDAs by performing HR-VWI scans in patients with VBDAs and obtaining quantitative parameters reflecting the inflammatory response of the aneurysm wall.

NCT ID: NCT06403423 Enrolling by invitation - Quality of Life Clinical Trials

Screening for Aortic Aneurysms in Inland Norway

NOR-AORTA
Start date: May 14, 2024
Phase:
Study type: Observational

The number of AAA-surgeries performed per capita is 3-4 times higher in Innlandet county, as compared to Oslo. The last three years the annual incidence of AAA requiring treatment has been 21.5 / 100 000 inhabitants in Innlandet, as compared to 6.6 / 100 000 in Oslo. The indication for surgery is the same in both regions. In Oslo, a screening program was established in 2011, reporting a prevalence of AAA of 2.6 %, but in Innlandet county all AAA are either symptomatic or incidental findings and the prevalence is unknown. The aetiology of the major difference in AAA prevalence between these two regions has not been previously explored.

NCT ID: NCT06400940 Recruiting - Clinical trials for Intracranial Aneurysm

Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia

Start date: August 17, 2023
Phase: Phase 4
Study type: Interventional

Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia

NCT ID: NCT06394271 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

Early Endovascular Repair Versus Surveillance for Women With Small Abdominal Aortic Aneurysm

WARRIORS
Start date: October 1, 2024
Phase: N/A
Study type: Interventional

Elective Abdominal Aortic Aneurysm (AAA) repair is offered when the risk of rupture exceeds the risk of surgery. Women (versus men) have a four-fold higher risk of AAA rupture but almost double the operative mortality. It is unknown whether the current 5.5cm diameter AAA repair threshold, derived from randomised trials including only 4% women, is applicable to women. Therefore, should women have their aneurysms repaired electively at smaller diameters than men to improve their AAA-related survival and quality of life? WARRIORS is an international randomised controlled trial of early elective endovascular repair versus routine surveillance in women (n=1112) with small asymptomatic AAA (4-5.4cm diameter), nested within a registry of non-participants. The surveillance group will be offered repair for rupture or upon reaching the 5.5cm threshold. Randomisation will be 1:1 stratified by country, age, and aneurysm diameter. The trial is powered for aneurysm-related mortality or rupture at 5 years. Quality-Adjusted-Life-Years is a major secondary outcome. Other outcomes include: operative mortality and complications, anxiety, major cardiovascular adverse events, and cost-effectiveness. Quality-of-life and anxiety questionnaires and "standard-of-care" using routine data will be collected. The trial aims to progress health equity through provision of evidence for sex-specific clinical guidelines for AAA repair.

NCT ID: NCT06385379 Recruiting - Clinical trials for Aortic Arch Aneurysm

Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)

Start date: April 30, 2024
Phase: N/A
Study type: Interventional

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)

NCT ID: NCT06380595 Enrolling by invitation - Clinical trials for Abdominal Aortic Aneurysm

Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms

CEVARII
Start date: February 21, 2024
Phase:
Study type: Observational

Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533.