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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 [1922 Associated Clinical Trials listed on BioPortfolio]

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...

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 ...

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 [16262 Associated PubMed Articles listed on BioPortfolio]

Incidence of seizure in stroke patients treated with recombinant tissue plasminogen activator: A systematic review and meta-analysis.

Background Recombinant tissue plasminogen activator is the only FDA-approved thrombolytic agent for acute stroke treatment. However, there are concerns that recombinant tissue plasminogen activator ma...

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 ...

Clinical Predictors of Stroke Mimics in Patients Treated with Recombinant Tissue Plasminogen Activator according to a Normal Multimodal Computed Tomography Imaging.

Multimodal computed tomography imaging (MCTI) is increasingly used for rapid assessment of acute stroke. We investigated characteristics and final diagnoses of patients treated with recombinant tissue...

Streamlining the Process for Intravenous Tissue Plasminogen Activator.

For ischemic stroke, the chance of improved recovery is directly impacted by length of time from symptom onset to administration of intravenous tissue plasminogen activator (IV tPA). Despite the impor...

Plasma let-7i and miR-15a expression are associated with the effect of recombinant tissue plasminogen activator treatment in acute ischemic stroke patients.

Circulating microRNAs (miRNAs) have been reported as diagnosis biomarkers and predictors in acute ischemic stroke (AIS). However, how the expression of circulating miRNAs changes after recombinant tis...

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.

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

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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