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Intracranial Aneurysm clinical trials

View clinical trials related to Intracranial Aneurysm.

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NCT ID: NCT01801072 Completed - Clinical trials for Intracranial Aneurysms

Seizure Prophylaxis in Aneurysm Repair

SPAR
Start date: February 2013
Phase: Phase 4
Study type: Interventional

After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility. The study will be extended to June 2024 to allow for a 5 year follow up of the last enrolled patient in June, 2019.

NCT ID: NCT01801007 Completed - Clinical trials for Intracranial Aneurysms

Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

FRED
Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.

NCT ID: NCT01793792 Completed - Clinical trials for Intracranial Aneurysms

Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)

LVIS
Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.

NCT ID: NCT01787123 Completed - Clinical trials for Subarachnoid Hemorrhage

Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin™ in Patients With Aneurysmal Subarachnoid Hemorrhage

CESAR
Start date: December 1, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, placebo-controlled, single-center clinical trial investigating the effectiveness of administrating intravenous Cerebrolysin™ (EVER NEURO Pharma, Austria), a preparation of low-molecular weight neurotrophic peptides and free amino acids, in improving the functional outcome of patients suffering from aneurysmal subarachnoid haemorrhage ( SAH). Cerebrolysin™ is a porcine-derived intravenous formulation composed of multiple lipid-soluble active agents that can cross the blood-brain barrier. It is a registered medication in several countries indicated for stroke and Alzheimer's disease. It contains several low molecular weight neuropeptides and free amino acids that possess neuroprotective and neurotrophic properties. It has been proven to arrest or mitigate several crucial steps along the ischemic cascade in preclinical studies. Cerebrolysin™ has been extensively investigated in patients suffering from Alzheimer's disease, brain trauma and ischemic stroke with promising clinical results. It's use in SAH patients has never been investigated and it is believed that it may play a role in improving clinical outcomes. Consecutive patients aged 18 to 70 years-old diagnosed to have spontaneous subarachnoid hemorrhage secondary to a ruptured intracranial aneurysm will be randomly allocated into one of two study arms: (1) to receive intravenous Cerebrolysin™ in additional to standard of care (intervention group) or (2) to receive usual standard of care alone (control group). Permuted-block randomization will be carried out once the eligibility criteria have been fulfilled using a computer system with an allocation list of random order. Instructions on study arm allocation will be contained in sealed envelopes labeled with sequential study numbers. Patients presenting beyond 96 hours after onset of symptoms or if recruitment and randomization cannot be performed within this time period will be excluded. The reason being that post-SAH arterial vasospasm and delayed cerebral ischemia usually occurs four days after aneurysm rupture and lasts for two weeks i.e. 14 days. Should this complication arise before Cerebrolysin™ is administered there would be significant confounding of trial outcome measures . The timing of intervention is in keeping with several landmark clinical studies that have dealt with neuroprotective agents in subarachnoid hemorrhage. Patients in the intervention group will receive in a daily total dose of 30ml of intravenous Cerebrolysin™. The study medication will be administered in three separate 10ml doses (every eight hours) diluted in 0.9% NaCl saline to a total volume of 100 ml as an intravenous infusion over a time period of 15 minutes. An identical amount of 0.9% sodium chloride (NaCl) saline (100 ml) will be used as placebo for patients allocated to the control study group. The total duration of study medication or placebo administration will be 14 days. Cerebrolysin™ is a clear yellow solution. Since it is susceptible to photo-degeneration the preparation after dilution with 0.9% NaCl saline requires masking with a opaque plastic wrap as well as special photo-protective infusion sets. The dilution of the Cerebrolysin™ solution will be performed by ward nursing staff . Subjects in both trial groups will receive identically wrapped preparations so that both the functional outcomes assessor and patient are blind to the study arm allocation. In addition to general demographic data, clinical data including the admission Glasgow Coma Score, severity grading of SAH, hospital stay as well as the extended Glasgow Outcome Score and modified Rankin Score upon discharge, at three months and six months will be prospectively collected. The functional outcomes assessor will be an occupational therapist unaware of the subject's trial group allocation. Hypothesis: compared to patients receiving standard care for the management of aneurysmal subarachnoid hemorrhage alone (control), the additional administration of intravenous Cerebrolysin™ (intervention) within the acute phase of stroke is safe and improves functional outcome at six months after stroke.

NCT ID: NCT01778322 Completed - Clinical trials for Intracranial Aneurysm

WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

WEBCAST
Start date: December 2011
Phase:
Study type: Observational

The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

NCT ID: NCT01762137 Terminated - Clinical trials for Intracranial Aneurysm

LARGE Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy

LARGE
Start date: February 2013
Phase: Phase 4
Study type: Interventional

In this study, patients with large anterior circulation IAs with neck and fundus morphologies amenable to either traditional endovascular treatments using coils or reconstruction with the flow diversion will be randomly assigned to either treatment technique.

NCT ID: NCT01754051 Completed - Clinical trials for Intracranial Aneurysms

A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System

VOLCAN
Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.

NCT ID: NCT01753388 Withdrawn - Clinical trials for Wide Neck Intracranial Aneurysms

Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms

Start date: December 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.

NCT ID: NCT01748903 Recruiting - Clinical trials for Intracranial Aneurysms

TARGET Intracranial Aneurysm Coiling Registry

TARGET
Start date: February 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this prospective registry is to collect real world, post-marketing data on the use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients (150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with intracranial aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A post hoc analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be performed.

NCT ID: NCT01722409 Completed - Clinical trials for Intracranial Aneurysms

A Better Choice for Patients Undergoing Endovascular Coil Embolization

Start date: December 2012
Phase: Phase 4
Study type: Interventional

The investigators designed a double-blind, randomized placebo-controlled study to determine the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.