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Ischemic Stroke clinical trials

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NCT ID: NCT01874093 Terminated - Ischemic Stroke Clinical Trials

IMPACT- 24Bt Post Mech. Thrombectomy and/or rtPA TRIAL IMPlant Augmenting Cerebral Blood Flow 24 Hours From Stroke Onset

IMPACT-24Bt
Start date: May 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in a 24 hour window, in patients with an acute ischemic stroke in the anterior circulation, who received Mechanical Thrombectomy and/or IV-rtPA and Standard of Care.

NCT ID: NCT01870492 Terminated - Ischemic Stroke Clinical Trials

Improving Patient Access to Stroke Therapy Study

IMPACT
Start date: January 2014
Phase: N/A
Study type: Observational

Limited access is a major hurdle in the treatment of AIS; many hospitals, especially rural hospitals, do not have the infrastructure or medical support to effectively treat AIS patients.5 Failure to recognize the signs and symptoms of stroke by the patient and/or emergency medical services (EMS) is another barrier to the timely treatment of AIS. Several studies, including the Paul Coverdell National Acute Stroke Registry (PCNASR), have reported low rates of adherence to stroke care guidelines, suggesting that many AIS patients do not receive proper treatment according to established guidelines. Thus, there remains an increasing need to assess and address the barriers that prevent patient access to proper AIS treatment. Annually, approximately 20,000 patients are discharged from Wisconsin hospitals with the diagnosis of stroke and an estimated 4,000 patients die from stroke each year in WI. To date, there have been no statewide studies initiated in Wisconsin to assess the regional barriers to the treatment of AIS patients with thrombolytic or endovascular therapy, and many hospitals do not routinely collect and analyze AIS patient data. The goal of the Improving Patient Access to Stroke Therapy (IMPACT) pilot study is to engage community hospitals statewide to identify the regional barriers to AIS therapy in WI.

NCT ID: NCT01852201 Terminated - Ischemic Stroke Clinical Trials

POSITIVE Stroke Clinical Trial

Start date: September 2013
Phase: N/A
Study type: Interventional

Primary Endpoint: The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT with respect to endpoint defined as: • 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw mRS scores. Statistical details can be found in section 7.2. Secondary Endpoints: - 90-day global disability in the 6-12 hr cohort assessed via the overall distribution of mRS - Proportion of patients with good functional recovery for the 6-12 hr cohort as defined by mRS 0-2 at 90 days - Mortality at 30 and 90 days - Intracranial hemorrhage with neurological deterioration (NIHSS worsening >4) within 24 hours of randomization - Procedure related serious adverse events (SAE's) - Arterial revascularization measured by TICI 2b or 3 following device use

NCT ID: NCT01811693 Terminated - Ischemic Stroke Clinical Trials

Field Administration of Stroke Therapy-Blood Pressure Lowering

FAST-BP
Start date: April 2013
Phase: Phase 2
Study type: Interventional

This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin) administered by paramedics in the field within 2 hours of symptom onset to 45 severely hypertensive stroke patients. The primary objective of the study is to evaluate the feasibility, safety, and physiologic efficacy of field-initiated glyceryl trinitrate in achieving modest reduction of blood pressure. Patients with acute stroke will be identified in the field by paramedics who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. Physician-investigators will obtain informed consent for each subject for study entry after cellular phone contact with paramedics. Paramedics will initiate antihypertensive treatment by applying transdermal GTN patch in the first two dose-tiers, and administering a single sublingual GTN metered spray followed by application of the transdermal system in the last dose tier. The sites involved in the study will be emergency medical services rescue ambulances and 8 receiving Stroke Center hospitals in Orange County, California, USA.

NCT ID: NCT01778335 Terminated - Ischemic Stroke Clinical Trials

Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke

ESCAPE
Start date: January 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to understand whether a new treatment of stroke - endovascular clot removal - can be added to the current standard of care to improve patient outcomes. All patients will receive the best standard stroke treatment. This includes treating patients with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA does not work in some patients and others are not eligible to receive t-PA because they present too late for treatment (they woke up with their stroke symptoms or their stroke was not witnessed). During endovascular revascularization the blockage in the artery is removed with the use of devices called stentreivers and or by giving clot dissolving drug at the site of the blockage in the artery to restore blood flow. Stentrievers are devices that have been designed by different companies to remove blood clots from arteries. Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will participate in this study.

NCT ID: NCT01643525 Terminated - Ischemic Stroke Clinical Trials

Study to Test Sensitivity and Specificity of Passive Wave Pressure Device in Determining Ischemic Stroke

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

That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity to hyper acute ischemic stroke than does CT.

NCT ID: NCT01519076 Terminated - Ischemic Stroke Clinical Trials

A Safety Evaluation of the Use of Magnetic-guided Iron Particles

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This study is a prospective trial wherein each included subject will receive the experimental magnetically enhanced diffusion therapy. It will be conducted on a maximum of ten adult male or female patients who meet the inclusion and exclusion criteria and informed consent has been obtained. Subjects presenting in the emergency department with acute ischemic stroke and are eligible for tPA therapy may be considered for inclusion in the study.

NCT ID: NCT01492725 Terminated - Ischemic Stroke Clinical Trials

Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial

EXTEND-IA
Start date: June 2012
Phase: Phase 2
Study type: Interventional

Patients presenting to the emergency department with acute ischaemic stroke, who are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for "dual target" major vessel occlusion and mismatch to determine their eligibility for randomisation into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intra-arterial clot retrieval after IV tPA or IV tPA alone. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.

NCT ID: NCT01464788 Terminated - Ischemic Stroke Clinical Trials

Randomized Controlled Trial of Argatroban With Tissue Plasminogen Activator (tPA) for Acute Stroke

ARTSS-2
Start date: October 2011
Phase: Phase 2
Study type: Interventional

Randomized controlled clinical trial to estimate overall treatment benefit (improvement in disability) among stroke patients treated with rt-PA who are randomized to also receive either low-dose Argatroban, high-dose Argatroban or neither.

NCT ID: NCT01220739 Terminated - Ischemic Stroke Clinical Trials

Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery

StELLAR
Start date: June 2011
Phase: Phase 1/Phase 2
Study type: Interventional

To assess the safety and preliminary efficacy of combining intravenous rt-PA with transcranial laser therapy (TLT) with the NeuroThera® Laser System (referred to hereafter as NTS) in subjects treated for acute ischemic stroke. Treatment with IV rt-PA must begin within 3 hours of symptom onset, and the initiation of TLT procedure must be feasible for each subject within 6 hours of stroke onset. The NeuroThera® Laser System is an investigational device that provides noninvasive transcranial laser therapy to subjects diagnosed with acute ischemic stroke. The wavelength of the laser light is in the infrared zone of the electromagnetic spectrum and is invisible to the naked eye.