View clinical trials related to Intracranial Aneurysm.
Filter by:The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.
The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms. The eCLIPs device is a novel shield like implant that is placed across the neck of the aneurysm and not only facilitates coil retention but also partly obstructs the flow of blood into the aneurysm. This is an early feasibility study, which is a small study investigating an innovative device to gather more clinical data before conducting a larger study. The safety and the effects of the device on the aneurysm will be studied for 12 months after the procedure among 15 patients at approximately 4 participating hospital centers. A larger study will be required to determine the safety and efficacy of the eCLIPs device for the treatment of wide-necked bifurcation aneurysms.
Cerus Endovascular is sponsoring a prospective, multi-center PMCF to document the safety and performance of the Contour Neurovascular System™ (hereinafter "Contour") in normal medical use.
The purpose of this study is to learn about protecting the brain from low blood flow (ischemia) with limb preconditioning. From human studies the investigators know that the brain can be protected from dangerous low blood flow by reducing the blood flow to an arm or leg for just a short period of time. This is called limb preconditioning. The investigators are studying the safety and feasibility of preconditioning and their effect of protecting the brain from ischemia in two different groups. This is a Phase 2, randomized, double-blind, sham-controlled, design. Up to 50 male and female patients undergoing elective endovascular repair of unruptured brain aneurysm who are randomized to the remote ischemic preconditioned or sham group will be enrolled. This study consists of one 3-9 month study period for each patient plus up to 14 days for enrollment activities. Subjects are required to return between 3-9 months for end-of-study procedures.
Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. The WEB was designed to treat wide-neck bifurcation aneurysms. This observational study will collect data about the routine practice in one center of using the WEB in ruptured and unruptured intracranial aneurysms. The primary objective is to evaluate its efficacy by assessing the anatomic outcome during follow-up.
The purpose of this study is to determine whether mild hypothermia causes reduction of vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of vasospasms during the period of 14 postoperative days measured by transcranial Doppler.
Identifying and making a decision about the best health treatment or screening option can be difficult for patients. Decision aids can be used when there is more than one reasonable option, when no option has a clear advantage in terms of health outcomes, and when each option has benefits and harms that patients may value differently. Decision aids may be pamphlets, videos, or web-based tools. They make the decision explicit, describe the options available, and help people to understand these options as well as their possible benefits and harms. This helps patients to consider the options from a personal view (e.g., how important the possible benefits and harms are to them) and helps them to participate with their health practitioner in making a decision. Cerebral aneurysms are common and potentially very dangerous. However, there are important treatment choices that may prevent bleeding and stroke before aneurysm rupture.Current procedural options are clipping and endovascular coiling. The anatomy of most aneurysms is amenable to either treatment. The treatment decisions are not simple, since each choice has its own trade-offs. How the benefits and trade-offs are valued varies across different patients, and, therefore, the right treatment decision needs to include greater patient participation. This starts with better communication of the probabilities associated with the outcomes of each option in terms that can be understood by patients. Equally important is helping the patients clarify their own treatment goals, as well as legitimizing patients' partnership in the decision-making process. Tools (e.g., decision aids) to achieve shared decision-making, are lacking in this area of medicine. We propose to investigate the impact of such decision aids on patient satisfaction and the outcomes of cerebral aneurysm coiling and clipping. Aim 1. To determine whether structured decision aids offered to cerebral aneurysm patients are associated with increased patient participation in the decision making process as indicated by the OPTION score Aim 2. To determine whether structured decision aids offered to cerebral aneurysm patients are associated with improved quality of life and patient satisfaction outcomes immediately preoperatively, and 30 days postoperatively.
The study objective is to evaluate the safety and effectiveness of the MicroVention FRED System when used in the treatment of wide-necked intracranial aneurysms.
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.
The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and second-generation MicroVention hydrogel coils for treatment of previously treated or untreated ruptured and unruptured intracranial aneurysms.