A Single-arm Trial of the Flow Diverter (Tonbridge) For Endovascular Treatment of Intracranial Aneurysms...
Intracranial AneurysmThe purpose of this study is to assess the effectiveness and safety of the Flow Diverter (Tonbridge) by collecting data from subjects who receive endovascular treatment of intracranial aneurysms.
Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)
Aneurysmal Subarachnoid HemorrhageVasospasm6 moreThis is a monocentric randomized prospective trial comparing 2 different endovascular strategies of intracranial arterial angioplasty in case of refractory intracranial arterial vasospastic stenosis : chemical angioplasty chemical and mechanical angioplasty
Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study)
AneurysmIntracranial Aneurysm4 moreIn recent years, many developments have been made to the tools and techniques used to treat IAs via endovascular intervention. Specifically, to the detachable coils themselves. In March 2018, the US Food and Drug administration granted Balt USA 510(k) clearance for the Optima Coil System™. Earlier this year, the list of devices included within the system has expanded to include OptiMAX Complex Super Soft and Complex Soft coils. It consists of coils that come in Standard, Soft and Super Soft profiles and allows for instant detachment from the pusher. The APPLY study is a prospective, single-center investigator-initiated study meant to assess the use of the Balt Optima™ Coil System. The site is looking to enroll approximately 30 subjects over the course of two years. The Optima Coil System™ is commercially available in the United States as such this study is looking for real-world data.
Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms
Wide Neck Saccular Cerebral AneurysmsIntracranial aneurysm (IA) is a cerebrovascular disorder in which the weakness of a cerebral artery wall causes a localized dilation of the blood vessel. Intracranial aneurysm can develop and rupture, and about 85% of spontaneous subarachnoid hemorrhage (SAH) cases are caused by the rupture of Intracerebral aneurysm. Two treatments are available globally: microsurgical clipping and endovascular treatment. Endovascular treatment of Intracerebral aneurysms using detachable platinum coils ( was introduced in 1990 by Guido Guglielmi, an Italian neurosurgeon ) of different shapes and sizes are deposited into the aneurysm through a microcatheter, which reduces the blood flow and induces thrombus formation . Wide neck aneurysm defined by neck diameter greater than 4 mm or dome-to-neck ratio less than 2 Despite advances in endovascular techniques , the treatment of wide-necked aneurysms remains problematic . Endovascular treatment of intracranial aneurysms is associated with lower morbidity and mortality rates and faster recovery compared with traditional microsurgical clipping. In wide-necked Intracerebral aneurysms, complete coil embolization is often technically difficult owing to the risks of distal coil migration or coil impingement on the parent vessel . Complete coil embolization using a single microcatheter without a supporting device in cases of wide-necked Intracerebral aneurysm is technically difficult. Total occlusion rates have increased recently as a result of the advancement of supporting devices These may include balloon remodeling, use of three-dimensional (3D) coils (Russian Doll Technique), combined use of stents and coils (Stent assisted coiling), flow diverters, use of intrasaccular flow disruption (like WEB), Double catheter Technique or combined extra- and intrasaccular devices.
PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT...
Brain DiseasesAneurysm2 moreA trial to evaluate the safety and efficacy of the Tubridge flow-diverter stent for the treatment of intracranial wide-necked, small to medium-sized aneurysms.
Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial
Intracranial AneurysmThe goal of this clinical trial is to confirm the feasibility and safety of performing radiosurgery on unruptured, low-risk aneurysms in humans. Participants will choose if they want to undergo radiosurgery or not. Participants who choose not to have radiosurgery will be assigned to the observational group. Participants who choose to have radiosurgery performed will be assigned to the radiosurgery group. Participants in both groups will attend an initial exam session as well as four follow-up sessions: Day 0 Initial questionnaire CTA scan MRI Radiosurgery performed on patients in the radiosurgery group 6 months CTA scan Follow-up questionnaire 12 months CTA scan MRI Follow-up questionnaire 24 months CTA scan Follow-up questionnaire 36 months CTA scan MRI Follow-up questionnaire Researchers will compare the observational group and the radiosurgery group to see if there is a difference in the incidence of aneurysm rupture during the study period (3 years). The hypothesis is that radiosurgery should not increase the risk of aneurysm rupture.
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Intracranial AneurysmThe objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Intracranial AneurysmBrain Aneurysm3 moreIntracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed. One particularly promising innovation is the WEB (Woven EndoBridge), which permits placement of an intra-saccular flow diverting mesh across the aneurysm neck, but which does not require anti-platelet agent therapy. Currently, which treatment option leads to the best outcome for patients with WNBA remains unknown. There is a need to offer treatment with the WEB within the context of a randomized care trial, to patients currently presenting with aneurysms thought to be suitable for the WEB.
International Subarachnoid Aneurysm Trial II
Intracranial Hemorrhage Ruptured AneurysmThe purpose of this study is to compare the clinical outcome of surgical clipping and endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT Study.
Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms...
Brain DiseasesAneurysm2 moreA registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial aneurysms