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Ischemia clinical trials

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NCT ID: NCT04120610 Terminated - Clinical trials for Peripheral Artery Disease

FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia

Start date: December 9, 2019
Phase:
Study type: Observational [Patient Registry]

Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.

NCT ID: NCT04100681 Terminated - Clinical trials for Critical Limb Ischemia

Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication

FlowOx
Start date: August 19, 2019
Phase: N/A
Study type: Interventional

The objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market. The study will be carried out in a patient population with peripheral artery disease (claudicatio intermittens) to confirm its usefulness and in particular gather information for further improvements of the device related to this patient population. The data collected from the use of the CE-marked FlowOX™ device are change of walking distance, quality of life, and the patient's compliance.

NCT ID: NCT04095767 Terminated - Stroke, Ischemic Clinical Trials

Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke

SOLONDA
Start date: September 21, 2019
Phase: N/A
Study type: Interventional

The ANA catheter system (may also be designated as "ANA system", "ANA 18 -002" or "ANA device") is a distal access catheter designed to assist in neurovascular procedures by facilitating the insertion and guiding of other devices (i.e. retrieval devices and intravascular catheters) and restricting blood flow at the target position. It is a sterile, single-use, disposable intravascular device comprised of two coaxial catheters (delivery catheter and funnel catheter) consisting of sections of variable stiffness. The funnel catheter is comprised of a radiopaque nitinol braid (self-expanding funnel), covered by a continuous silicone coating that, when deployed, provides local and temporary flow restriction. The delivery catheter has a hydrophilic coating to reduce friction during use and a radiopaque marker on the distal end. Both catheters have Luer lock hubs on their proximal end. The proposed study has been designed to collect prospective clinical evidence to compare the Anaconda ANA device to similar devices used for guiding and supporting stent retrievers during neurothrombectomy procedures. The protocol has been designed to replicate the patient population enrolled in prior studies of similar devices. The primary endpoint will be ability of the investigational device to facilitate stentriever deployment and neurothrombectomy in the anterior circulation, with successful reperfusion defined as achieving a modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2b in the target vessel with ≤3 passes of the investigational device without the use of rescue therapy. Follow-up at 24h, Day 5 (+/- 12 h) or discharge, whichever comes first and at 90 days will allow documentation of the clinical outcome of the neurothrombectomy procedure as a whole and detect any device related and other complications, making use of the ANA device for distal access.

NCT ID: NCT04066738 Terminated - Heart Failure Clinical Trials

Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic Cardiomyopathy

Start date: September 27, 2017
Phase: N/A
Study type: Interventional

Cardiac Resynchronization Therapy (CRT) is a proven treatment for heart failure. CRT consists of a special pacemaker with two/three leads (insulated wires which take the electrical impulses from the device to the heart), one in the right ventricle, one in a vein on the outer surface of the left ventricle (in a vessel called coronary sinus or CS) and sometimes one in the right atrium (right top chamber of the heart). Tiny electrical impulses are simultaneously sent to the ventricles to make them beating together again in a more synchronised pattern. This leads to a coordinated, synchronous pumping action that, in most patients, translates into improved heart failure symptoms and improved quality and quantity of life, reducing the chance of being admitted to hospital with worsening heart failure. Unfortunately up to one third of the patients do not benefit from CRT therapy and to date there are no useful criteria to predict the response to CRT. In an effort to improve the response rate to CRT, alternative methods have been developed. In particular, a new technology called MultiPoint Pacing (MPP) (St. Jude Medical, Sylmar, CA) has recently become available. It allows simultaneous stimulation of 2 different points in the left ventricle by using a single lead with four electrodes. This strategy should improve the pumping function of the heart by recruiting a larger mass of muscle. Although MPP is as safe and as effective as standard CRT pacing, the improvements to date in the heart pump function it gives over standard CRT pacing are variable and small. Recent evidence suggests that MPP pacing could be particularly beneficial in some subgroups of patients, in particular patients with a previous history of heart attack resulting in scar formation in the left ventricle. The investigators hypothesize that MPP works better when the lead is closer to the scar because this allows recruitment of areas with slow conduction, thus increasing synchronization further. To this aim, they plan to compare, in each patient, the acute response produced by MPP on the cardiac function when the CS lead is placed close to myocardial scar and when it is placed far from scar respectively.

NCT ID: NCT04044391 Terminated - Clinical trials for Acute Coronary Syndrome

Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization

Start date: May 15, 2019
Phase:
Study type: Observational

This is a multicenter, prospective trial to measure the test performance characteristics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coronary artery obstruction in patients with symptoms of suspected acute coronary syndrome or who present with a failed stress test with the intention of treat with cardiac catheterization.

NCT ID: NCT03968198 Terminated - Clinical trials for Critical Limb Ischemia and Peripheral Artery Disease

Administration of Adipose-derived Stem Cells (ASC) in Patient With Critical Limb Ischemia.

ACellDREAM2
Start date: March 4, 2020
Phase: Phase 2
Study type: Interventional

Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries. Adipose derived stem cell, have shown in vitro and in vivo models a stronger potential of success in recovering from ischemic disease and oxygenation of the tissues. The investigators already shown in a phase I study, that adipose derived mesenchymal cells injected in patients with critical limb ischemia and no option for revascularization, had a very good tolerance and interesting effects on skin oxygenation and healing. The aim of the present clinical trial is to confirm the efficacy autologous transplantation of adipose tissue derived mesenchymal cells in patients with critical limb ischemia with poor options or no option for revascularization.

NCT ID: NCT03886129 Terminated - Clinical trials for Transient Ischemic Attack

Cerebral Haemodynamics in Transient Ischaemic Attack

Start date: April 16, 2019
Phase:
Study type: Observational

Adequate brain blood flow is essential for brain survival and function. Brain blood flow is kept relatively constant by a process called cerebral autoregulation (CA). CA is impaired in various diseases including head injury, diabetes, Alzheimer's, pre-eclampsia and stroke. In stroke, impaired CA is associated with poor outcomes. A transient ischaemic attack (TIA) is the same as a stroke, except the symptoms only last for a short amount of time and resolve spontaneously. TIAs are sometimes called mini-strokes and are a major warning sign of strokes. There have been lots of studies of CA in stroke, but very few studies of CA in TIA. Brain blood flow and CA can be studied non-invasively with Transcranial Doppler ultrasound (TCD). Study aim: To investigate whether CA is impaired in patients with TIA 20 patients with acute TIA (within 7 days), and 20 healthy controls will be recruited from the specialist TIA clinic at University Hospitals of Leicester NHS Trust. Participants will be eligible if they are aged over 18 and can consent to participate. They won't be able to participate if they have severe heart failure, an irregular heartbeat, blocked neck blood vessels, severe breathing problems, or if they are pregnant. Participants will undergo an assessment of brain blood flow using TCD, during which their heart rate, breathing and blood pressure will also be monitored. During the assessment participants will sit quietly before being asked to stand and then complete a squat-stand manoeuvre in time with a computer sequence. The research visit will take approximately 90 minutes, the assessment itself will take approximately 1 hour and participants only need to attend once.

NCT ID: NCT03835039 Terminated - Clinical trials for HIE - Perinatal Hypoxic - Ischemic Encephalopathy

The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy

Start date: January 3, 2019
Phase:
Study type: Observational

A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.

NCT ID: NCT03809494 Terminated - Clinical trials for Critical Limb Ischemia

HemaTrate™ in the Treatment of Critical Limb Ischemia

Start date: July 23, 2019
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.

NCT ID: NCT03767192 Terminated - Clinical trials for Acute Ischemic Stroke

Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A)

ImpACT-24A
Start date: January 2009
Phase: N/A
Study type: Interventional

The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.