Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization...
Intracranial AneurysmThe purpose of this study is to evaluate the safety differences between intracranial support catheter and guide catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation.
Low Dose Prasugrel vs Clopidogrel for Stenting or Flow Diverter for Unruptured Aneurysm
Intracranial AneurysmLow clopidogrel response has been reported in about 5-44% of the total population, which is associated with an increase in thromboembolism. Recently prasugrel drug widely accepted as a good option for these patients. The purpose of this study is to compare the safety and usefulness of prasugrel versus clopidogrel in patients who are scheduled to undergo stent or diverter treatment for non-ruptured cerebral aneurysms.
Deferoxamine in Aneurysmal Subarachnoid Hemorrhage Trial
Intracranial AneurysmSubarachnoid HemorrhageAneurysmal subarachnoid hemorrhage (SAH) is a form of stroke in which secondary neurological deterioration is an important cause of mortality and morbidity. These secondary changes, so called delayed cerebral ischemia (DCI), are caused by lysis of erythrocytes which can react to form iron, an toxic substance to the brain. Iron chelators remove the excess of iron and are standard care in iron-overloaded patients. Deferoxamine (DFO) an chelator has not been evaluated in SAH patients. This study evaluates the safety of deferoxamine in SAH patients.
Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart...
Cardiac PacingArtificial4 moreRapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigators will study the safety of RVP, particularly for the heart and the brain.
Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification...
Cerebral AneurysmCerebral Aneurysm UnrupturedThe primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
Middle Cerebral Artery Aneurysm Trial
Middle Cerebral Artery AneurysmIntracranial aneurysms located on the middle cerebral artery (MCA) are considered by many surgeons to represent a distinct subgroup of aneurysms for which clipping may still be the best management option. Most MCA aneurysms are accessible, proximal control can readily be secured in case of rupture, and clip application can typically proceed without requiring the dissection of perforating arteries. In comparison, certain anatomic features of MCA aneurysms such as a wide neck, often including a branch artery origin, frequently render endovascular management more difficult. New endovascular devices were and continue to be introduced to address these anatomic difficulties, including stents, flow diverters, and intra-saccular flow disruptors (ISFDs) such as the WEB. Thus, while most aneurysms are increasingly treated with endovascular methods, many MCA aneurysm patients are still managed surgically, but convincing evidence of which management paradigm is best is lacking.
Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation
Intracranial AneurysmTo assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.
A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial...
AneurysmsA post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Wide Neck Bifurcation Intracranial AneurysmsA prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System
Intracranial AneurysmWide Neck Aneurysm2 moreThe objective of the proposed investigation is to assess the safety and effectiveness of the Merlin's DiVeRt system for the treatment of intracranial lesions. Merlin is a manufacturer of Flow- Diverters (FD) for Neurovascular applications. The technology is based on a microporous polymer membrane which is delivered to the site of lesion treatment using a metal stent scaffold. The first device in its FD family is the XCalibur Aneurysm Occlusion Device (AOD) system, which is delivered on a rapid-exchange balloon catheter which goes in a 6-Fr guide-catheter. The AOD is CE-marked and has been involved in the treatment of over 70 clinical lesion/aneurysm cases. The same technology is now being made available in a self-expandable stent platform delivered on a 0.028" microcatheter. Merlin has performed the required in-silico, in-vitro and in-vivo tests to be confident of the device performance and now intends to proceed to the human clinical-trials. DiVeRt (Interventional) is a non CE mark device. The device is under clinical trial phase. The competent authority submission for the study has been completed in Spain, Turkey and Hungary.