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Intracranial Aneurysm clinical trials

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NCT ID: NCT06303063 Recruiting - Clinical trials for Intracranial Aneurysm

Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms

Start date: January 17, 2024
Phase: N/A
Study type: Interventional

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.

NCT ID: NCT06282939 Recruiting - Clinical trials for Intracranial Aneurysm

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

OPTIMA
Start date: November 1, 2023
Phase:
Study type: Observational [Patient Registry]

This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System. The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures.

NCT ID: NCT06238115 Recruiting - Clinical trials for Thromboembolic Events

Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

TEAR
Start date: March 4, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy.

NCT ID: NCT06201598 Recruiting - Cerebral Aneurysm Clinical Trials

Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents

pSPAIN_HPC
Start date: January 12, 2024
Phase:
Study type: Observational

The use of flow-diverting stents for the endovascular treatment of cerebral aneurysms has proven to be effective and efficient in several clinical studies, leading to its widespread adoption. Devices with a higher number of filaments have a greater flow-diverting effect and less variation when there are changes in the caliber of the underlying vessel or in curved vessels. However, ischemic complications secondary to their implantation have been reported, prompting the development of various strategies to reduce their thrombogenicity. Phenox is the only company to date that has developed an anti-thrombogenic coating, known as HPC (Hydrophilic Polymer Coating), which, when applied to the p64 MW HPC and p48 MW HPC devices, has shown to reduce the likelihood of thromboembolic complications associated with their implantation.

NCT ID: NCT06189950 Recruiting - Clinical trials for Intracranial Aneurysm

Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE

Start date: October 30, 2023
Phase: N/A
Study type: Interventional

This trial was designed as a prospective, multicentre, open, non-inferiority, randomised controlled clinical trial, with the control devices being MicroVention's LVIS Intraluminal Support Device and LVIS Jr. Intraluminal Support Device. Approximately 200 subjects with intracranial aneurysms would be enrolled for stent-assisted coiling embolisation according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±60 days) postoperatively; subjects would underwent DSA imaging at surgery and at 6 months (±30 days) postoperatively, and MRA or DSA imaging at 12 months (±60 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of intracranial artery stent for stent-assisted coiling embolisation for the treatment of intracranial aneurysms.

NCT ID: NCT06189014 Recruiting - Aneurysm, Brain Clinical Trials

The International PERForator ANeurysm Registry (PERFAN)

PERFAN
Start date: November 9, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this international, multicenter, mixed retrospective-prospective, exploratory, observational study is to establish an international registry to fill the knowledge gap created by the rarity of lenticulostriate and basilar perforator aneurysms and the resulting lack of knowledge about their natural history, diagnostic evaluation, management, and clinical outcomes. Specifically, comparative analyses of outcomes in patients with intracranial perforator aneurysms treated conservatively, endovascularly, and surgically will be performed. The study will also evaluate the size and location of lenticulostriate and basilar intracranial perforator aneurysms, collect information on the specific type of endovascular treatment used, compare patients with predominantly perimesencephalic subarachnoid hemorrhage (SAH) who have a perforator aneurysm to those without, and evaluate spontaneous occlusion in conservatively treated aneurysms. Core lab analysis of these aneurysms on various imaging modalities will be performed at the Inselspital and changes in aneurysm characteristics over time will be documented. In addition, the relationship between baseline characteristics and aneurysm characteristics on the incidence of hemorrhage will be examined. The study will involve approximately 20-30 centers worldwide with an estimated total sample size of 200-300 patients by 2025.

NCT ID: NCT06174727 Recruiting - Clinical trials for Intracranial Aneurysm

International Registry of Flow Diverter Stents

IRF
Start date: October 1, 2023
Phase:
Study type: Observational

This multi-center retrospective cohort study aims to investigate the technical and clinical outcomes of intracranial aneurysms treated with Flow diverter stents.

NCT ID: NCT06158750 Recruiting - Clinical trials for Intracranial Aneurysm

To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms

Start date: November 17, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.

NCT ID: NCT06147102 Recruiting - Clinical trials for Intracranial Aneurysm

The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

HUIQE
Start date: January 1, 2023
Phase:
Study type: Observational

A research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. All consecutive patients with a non-ruptured intracranial aneurysms treated at Helsinki University Hospital will be included. Safety is measured by postoperative magnetic resonance imaging (MRI) taken 1-3 days after the treatment, treatment-related complications and functional outcome at three months. Effectiveness is measured by angiographic results and assessment of long-term bleeding from the treated aneurysm. Other outcomes include risk of developing epilepsy, getting a new stroke, and dementia on long-term follow-up.

NCT ID: NCT06134557 Recruiting - Clinical trials for Intracranial Aneurysm

Therapeutic Effect of Blood Flow Reconstruction in IVADA

Start date: December 20, 2023
Phase:
Study type: Observational

IVADA (Intracranial vertebral artery dissecting aneurysms)is one of the causes of subarachnoid hemorrhage or posterior circulation ischemia with high mortality and disability. Current endovascular therapies for IVADA mainly include parent artery occlusion and endovascular blood reconstructive techniques. The method of parent artery occlusion requires the sacrifice of one vertebral artery. For the IVADA patients whose dissection involves PICA(posterior inferior cerebellar artery)or anterior spinal artery, severe ischemia even infarction of brain stem or cerebellar may be caused after parent artery occlusion , they are usually irreversible damage, so that method are rarely used now.Endovascular flood reconstructive techniques has become the mainstream, including stent-alone or overlapping stent treatment ,stent-assisted coiling techniques, single flow diverter(FD) stents or flow diverter assisted coil, etc.With the improvements in stents, flow diverter stent is efficient, while they are associated with the risk of ischemia, especially when vital arterial branches are covered. It has been reported that FD techniques have certain advantages over traditional stents in the treatment of anterior circulating intracranial aneurysms. In the treatment of posterior circulating aneurysms, perioperative ischemic complications increase due to their influence on the blood flow of perforator arteries, but there are few long-term observations at present. Currently, studies directly contrasting flow diverter and conventional stents in patients with IVADA are rare. Therefore, we performed the study to compare the safety and efficacy between flow diverters and conventional stents in IVADA patients undergoing endovascular therapy. Stent-assisted coiling is the preferred option for most surgeons. In addition,It is believed that dense packing is not necessary as long as the aneurysm neck is covered to isolate the dissection. How ever,whether it is really necessary to adjunct coil,and if it is necessary, what is the ideal packing density of coils, there is no clear conclusion at present.This study aimed to compare the safety and efficacy between flow diverter and conventional stents in patients with IVADA, determine the ideal packing density of coils after FD stent placement,and to observe the hemodynamic changes before and after the treatment of FD stent.