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Ischemia clinical trials

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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: NCT04091945 Recruiting - Clinical trials for Acute Ischemic Stroke

A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS

Start date: January 27, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.

NCT ID: NCT04089917 Completed - Stroke, Ischemic Clinical Trials

A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients

TAPAS
Start date: September 16, 2019
Phase:
Study type: Observational

The purpose of this study is to collect real-world safety and performance data on the MIVI Neuroscience, Inc. Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke.

NCT ID: NCT04087382 Completed - Clinical trials for Acute Ischemic Stroke

Mechanical Thrombectomy in Acute Ischemic Stroke Beyond the Time of Window

AIS
Start date: January 15, 2019
Phase: N/A
Study type: Interventional

Background: intravenous alteplase appears to be much less effective at opening proximal occlusions of the major intracranial arteries, which account for more than one third of cases of acute anterior-circulation stroke and expanding time window using mechanical thrombectomy can improve clinical outcome in patients that would have only received conservative treatment. The aim of this work is to evaluate the effectiveness of endovascular therapy within 24 hours of symptom onset and to compare clinical outcome of endovascular therapy with the standard medical therapy at the end of 3rd month follow up. Material and Methods 57 subjects presenting with an acute ischemic stroke caused by occlusion of the proximal middle cerebral artery (M1 segment) or Internal carotid artery ( ICA segment) within 24 hours from symptom onset as documented by Ct, and or MRI perfusion were recruited consecutively from 2 University hospitals Ain shams University Hospital (32 Patients) and Aswan University (25 patients). Assessment of each subject was performed using NIHSS, and MRS, Aspect score, before intervention. Follow up was done using the same clinical scale one week and the 3 month after the onset. Primary outcome NIHSS and MRS at the end of 3 month after the onset. secondary outcome complications (cerebral Hge) and death at 3 months.

NCT ID: NCT04081974 Completed - Clinical trials for Perfusion; Complications

Prevalence and Predictors of Distal Limb Ischemia in Minimally Invasive Cardiac Surgery.

Start date: November 25, 2019
Phase:
Study type: Observational

Peripheral arterial cannulation is a necessity for installation of cardiopulmonary bypass in minimally invasive cardiac surgery (MICS). In the vast majority of cases, the femoral artery is the preferred arterial cannulation site. Distal limb hypoperfusion and ischemia can occur in the cannulated limb since antegrade perfusion is not routinely provided. Furthermore, the diameter of the cannula required to maintain adequate cardiopulmonary bypass (CPB) flow is often approaching that of the patient's femoral artery diameter, compromising distal blood flow. The possibility of distal limb ischemia is often raised as a criticism to peripheral cannulation for cardiopulmonary bypass and by extent to minimally invasive cardiac surgery. Ischemia of the lower limb is of high incidence in patients undergoing extracorporeal membrane oxygenation (ECMO) therapy, in which the same femoral cannulation technique is used. Therefore this complication has extensively been described in ECMO literature. However, no clinical trials have been performed in patients undergoing MICS, despite the same cannulation and perfusion route. ECMO patients often differ from MICS patients in morbidity as well as in duration of cannulation. Up to now, one could not observe any clinical sequelae of limb ischemia in MICS patients but a formal study of distal leg perfusion in MICS is recommended to screen its safety and to identify possible risk factors.

NCT ID: NCT04080830 Recruiting - Atrial Fibrillation Clinical Trials

Registration Study of Acute Ischemic Stroke/Transient Ischemic Attack (TIA) With Atrial Fibrillation

AISWAF
Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

Patient Registration Study of Acute Ischemic Stroke/transient ischemic attack(TIA) With Atrial Fibrillation (AISWAF) is a single-center prospective, consecutively, observational study, was conducted in patients with acute ischemic stroke/TIA with atrial fibrillation. The aim of this study was to understand the stroke mechanism, the regularity of stroke recurrence and its influencing factors, to establish a risk stratification model for stroke recurrence, and to preliminarily explore the relationship between stroke mechanism, risk stratification and antithrombotic regimen in this population.

NCT ID: NCT04075500 Recruiting - Atrial Fibrillation Clinical Trials

Optimal Detection of Atrial Fibrillation in TIA

ODEA-TIA
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Transient ischemic attack (TIA) is a common neurologic emergency. Although the detection of atrial fibrillation (AF) has identical consequences for preventive therapy in patients with ischemic stroke and TIA, the management setting and diagnostic pathways frequently differ substantially between both manifestations. Despite these differences between stroke and TIA patients, previous studies have investigated diagnostic work-up for AF primarily in stroke patients. Thus, there is no common practice or "gold standard" of rhythm monitoring for TIA patients in most healthcare systems and the optimal method and duration of cardiac monitoring for TIA patients is currently unknown. This is likely to result in a substantial under-diagnosis of AF in TIA patients, failure to initiate appropriate secondary preventive medication (i.e. anticoagulation) and ultimately the occurrence of many otherwise preventable strokes. The primary research question of the trial is whether prolonged ECG recording (intervention) significantly increases the rate of detection of paroxysmal AF compared to 24 h electrocardiogram (ECG) monitoring (control) 6 months after start of monitoring in patients with recent TIA. The co-primary question of the trial is whether 28 d non-invasive continuous ECG monitoring is non-inferior to ECG recording using an implanted event recorder for AF detection.

NCT ID: NCT04073121 Completed - Clinical trials for Critical Limb Ischemia

Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia

MERLION
Start date: December 27, 2018
Phase: N/A
Study type: Interventional

This study aims to evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, presenting with critical limb ischemia.

NCT ID: NCT04072705 Completed - Clinical trials for Acute Ischemic Stroke

Clopidogrel Preventive Effect Based on CYP2C19 Genotype in Ischemic Stroke

Start date: September 20, 2019
Phase:
Study type: Observational

The hypothesis of this study is that "the poor metabolizer or intermediate metabolizer of the cytochrome P450 2C19 genotype in patients with acute ischemic stroke is associated with increased risk of composite cardiovascular events (recurrent stroke, myocardial infarction, cardiovascular death) compared to those who of extensive metabolizer of the cytochrome P450 2C19 genotype".

NCT ID: NCT04071808 Completed - Clinical trials for Painless Myocardial Ischemia

Painless Myocardial Ischemia in Diabetic Patients.

Start date: October 1, 2019
Phase:
Study type: Observational

This study aims to investigate the relationship between the concentrations of blood orphanin, norepinephrine and the morbidity of painless myocardial ischemia in patients with diabetes mellitus. Hopefully, the biomarker(s) in the blood of diabetic patients can be found for screening high risk patients in the diabetes sufferers to prevent the painless myocardial ischemia.