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Aneurysm clinical trials

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NCT ID: NCT01000675 Completed - Cerebral Aneurysms Clinical Trials

Registry for Study of Coils in Intracranial Aneurysms

Gel-the-nec
Start date: August 2009
Phase:
Study type: Observational

The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.

NCT ID: NCT00994045 Completed - Clinical trials for Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair

Fibrinogen as an Alternative to FFP in Aortic Surgery.

Start date: June 2010
Phase: Phase 4
Study type: Interventional

Thoracoabdominal aneurysm (TAAA) repair is a major elective vascular operation associated with a large blood loss and potentially life-threatening clotting abnormalities. Theses clotting abnormalities are principally treated using fresh frozen plasma (FFP) (derived from human blood donations), the administration of which carries a number of risks including virus transmission (human immunodeficiency virus (HIV), hepatitis B, hepatitis C) and infection with variant Creutzfeld-Jacob disease (vCJD). FFP is no longer administered to children or high-usage adults in the UK because of the infection risk, and recently it was decided by a UK advisory body that the use of UK-derived FFP should cease. Fibrinogen concentrate is an alternative treatment option to FFP which is thought have less infection risk (purified, heat treated) and has been in licensed use for many years in other European countries. The investigators have been using fibrinogen concentrate recently in their department as an alternative to FFP with encouraging results. 20 patients undergoing elective TAAA repair at The Royal Infirmary of Edinburgh will be randomly allocated to receive standard treatment (FFP) or fibrinogen concentrate as treatment for clotting abnormalities during their surgery. The investigators will take a number of additional blood samples which will provide valuable information about the pattern of clotting abnormalities during this type of operation. The investigators will also record blood loss and the number of allogeneic (derived from human donors) blood components transfused to the patient (red cells, FFP and platelets). Our primary objective is to assess the pattern of coagulation abnormalities in both groups. We will also examine whether the use of fibrinogen concentrate during TAAA repair avoids the need to administer FFP.

NCT ID: NCT00993057 Completed - Clinical trials for Intracranial Aneurysm

Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia

Start date: October 2009
Phase: Early Phase 1
Study type: Interventional

What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to every hour will help them reach target glucose levels faster and maintain them more efficiently with the same insulin protocol.

NCT ID: NCT00928265 Completed - Clinical trials for Intracranial Aneurysm

Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

SENAT
Start date: July 2008
Phase: N/A
Study type: Observational

This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis. The objectives of this study are: 1. Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS). 2. to evaluate adverse events. 3. Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.

NCT ID: NCT00883363 Completed - Clinical trials for Abdominal Aortic Aneurysm

Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

PreconRAAA
Start date: April 2009
Phase: N/A
Study type: Interventional

Preconditioning in patients treated for elective abdominal aneurysm showed that the rate of perioperative myocardial infarction could be reduced by 80 %(ARR from 27% to 5%). Precondition where performed by 10 minutes of clamping of each iliac arteries before clamping the abdominal aorta. Human studies in cardiac patients have shown promising results with precondition. Instead of clamping arteries they have all performed the procedure by inflating a blood pressure cuff above arterial pressure on a arm. The investigators want to investigate if preconditioning induced by a blood pressure cuff on a arm can reduce the perioperative rate of myocardial infarction in patients open operated for ruptured abdominal aortic aneurysm.

NCT ID: NCT00879580 Completed - Clinical trials for Intracranial Aneurysm

Enterprise Stent Aneurysm Treatment (ESAT) Study - France

ESAT
Start date: February 2009
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.

NCT ID: NCT00878371 Completed - Clinical trials for Dissecting Aneurysm of the Thoracic Aorta

Effects of a Surgery-induced Peripheral Inflammatory Response on the Blood Brain Barrier

Start date: May 2009
Phase: Phase 4
Study type: Interventional

The purpose for this study is to determine if surgery (repair of descending thoracic aneurysm) causes a temporary decrease in the Blood Brain Barrier's ability to remove drugs from the brain back into the blood. The Blood Brain Barrier surrounds the brain and the spinal cord. This Blood Brain Barrier acts as a filter and allows some things to cross into the brain and allows other matter to be removed. Studies have shown the Blood Brain Barrier is affected by inflammation. Functions of the Blood Brain Barrier in animals have been studied. Human studies with multiple causes of inflammation (e.g. Alzheimer's, Epilepsy, trauma and severe infections in critically Hypothesis: Surgically-induced inflammation will temporarily reduce blood-brain barrier drug efflux transporter function in proportion to the degree of inflammation. The investigators anticipate that inflammation-mediated reductions in drug transporter function will be reflected by an increased cerebral spinal fluid (CSF) concentration of morphine (a PGP substrate) and M3G and M6G (MRP1 substrates). The corresponding in vitro studies will allow us to elucidate the mechanism(s) by which inflammation alters blood brain barrier efflux transport of morphine, M3G and M6G.

NCT ID: NCT00875563 Completed - Clinical trials for Abdominal Aortic Aneurysms

Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

Start date: January 2005
Phase: N/A
Study type: Interventional

The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

NCT ID: NCT00870051 Completed - Clinical trials for Aortic Aneurysm, Abdominal

Endurant Stent Graft Natural Selection Global Postmarket Registry

ENGAGE
Start date: April 8, 2009
Phase:
Study type: Observational

The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

NCT ID: NCT00833924 Completed - Clinical trials for Abdominal Aortic Aneurysms

Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

Start date: May 2008
Phase: N/A
Study type: Interventional

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.