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Safety and Efficacy of the Penumbra™ System in Acute Middle Cerebral Artery (MCA) Stroke

2014-08-27 03:13:20 | BioPortfolio

Summary

Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. However, no solid scientifical data is available to date. The investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can improve clinical outcomes in a specific stroke setting.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Stroke

Intervention

Penumbra™ System, Recombinant tissue plasminogen activator

Location

Hospital de Clinicas de Porto Alegre
Porto Alegre
Rio Grande do Sul
Brazil
90035-903

Status

Not yet recruiting

Source

Hospital de Clinicas de Porto Alegre

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:20-0400

Clinical Trials [2163 Associated Clinical Trials listed on BioPortfolio]

Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)

To determine whether the extent of the ischemic penumbra apparent on perfusion-diffusion MRI can be used to identify patients who would respond positively and safely to tissue plasminogen ...

Extending the Time for Thrombolysis in Emergency Neurological Deficits

The primary hypothesis being tested in this trial is that ischaemic stroke patients selected with significant penumbral mismatch (measured by MRI criteria) at 3 - 9 hours post onset of str...

Thrombolytic Care During Inter-hospital Transfer

Evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtPA) during air ambulance transfer

Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)

The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is better for treating stroke patients and if TNK offers an advantage over currently available tr...

Interventional Management of Stroke (IMS) Study

The purpose of this study is to examine the effects of delivering recombinant tissue plasminogen activator (rt-PA) and ultrasound to the site of the blood clot blocking blood flow to the b...

PubMed Articles [16105 Associated PubMed Articles listed on BioPortfolio]

Successful Tissue Plasminogen Activator for a Patient with Stroke After Stanford Type A Aortic Dissection Treatment.

Some stroke patients with the acute aortic dissection receiving thrombolysis treatment resulted in fatalities. Thus, the concurrent acute aortic dissection is the contraindication for the intravenous ...

Intraosseous Administration of Tissue Plasminogen Activator on a Mobile Stroke Unit.

Mobile stroke units offer improved time to administration of thrombolytics for ischemic stroke patients. Acquisition of intravenous (IV) access, however, can be challenging in the pre-hospital environ...

Estimation of seizures prevalence in ischemic strokes after thrombolytic therapy.

Post stroke seizures are a complication that occur in 5-20% of acute ischemic stroke (AIS) patients, cause a reduction in quality of life and a greater burden on the health system. There is not enough...

Modeling of post-stroke stimulation of cortical tissue.

Following a stroke, cortical networks in the penumbra area become fragmented and partly deactivated. We develop a model to study the propagation of waves of electric potential in the cortical tissue w...

Endovascular stroke treatment does not preclude high thrombolysis rates.

In 1995 intravenous recombinant tissue plasminogen activator (IVRTPA) was the first reperfusion therapy to be approved in patients with acute ischemic stroke (AIS). The significance and impact of IVRT...

Medical and Biotech [MESH] Definitions

An acylated inactive complex of streptokinase and human lysine-plasminogen. After injection, the acyl group is slowly hydrolyzed, producing an activator that converts plasminogen to plasmin, thereby initiating fibrinolysis. Its half-life is about 90 minutes compared to 5 minutes for TPA; (TISSUE PLASMINOGEN ACTIVATOR); 16 minutes for UROKINASE-TYPE PLASMINOGEN ACTIVATOR and 23 minutes for STREPTOKINASE. If treatment is initiated within 3 hours of onset of symptoms for acute myocardial infarction, the drug preserves myocardial tissue and left ventricular function and increases coronary artery patency. Bleeding complications are similar to other thrombolytic agents.

A proteolytic enzyme in the serine protease family found in many tissues which converts PLASMINOGEN to FIBRINOLYSIN. It has fibrin-binding activity and is immunologically different from UROKINASE-TYPE PLASMINOGEN ACTIVATOR. The primary sequence, composed of 527 amino acids, is identical in both the naturally occurring and synthetic proteases.

An extracellular receptor specific for UROKINASE-TYPE PLASMINOGEN ACTIVATOR. It is attached to the cell membrane via a GLYCOSYLPHOSPHATIDYLINOSITOL LINKAGE and plays a role in the co-localization of urokinase-type plasminogen activator with PLASMINOGEN.

Member of the serpin family of proteins. It inhibits both the tissue-type and urokinase-type plasminogen activators.

A member of the serpin family of proteins. It inhibits both the tissue-type and urokinase-type plasminogen activators.

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Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...


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