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Ischemia clinical trials

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NCT ID: NCT02544542 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage

Start date: January 2014
Phase: N/A
Study type: Interventional

This study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be treated by the widely-used hyper-hypothermia blanket method, while the other half will be treated by the investigators' new method.

NCT ID: NCT02542345 Recruiting - Myocardial Ischemia Clinical Trials

Comparative Assessment of Coronary MR Angiography Vs Coronary Multislice CT After Coronary Artery Reimplantation in Children and Young Adults.

IRCADO
Start date: May 2011
Phase: N/A
Study type: Interventional

This is a prospective, multicentric study conducted in order to evaluate if MRI coronarography is as powerful as Cardiac Multislice CT in detection of coronary abnormalities after coronary reimpantation in children over 5 yo, teenagers and young adults who underwent coronary reimplantation in childhood. Newborns suffering from transposition of the great vessels who underwent at neonatal age an arterial switch operation (ASO) with coronary reimplantation, may develop in time with growth, stenosis, twist or elongation of the reimplanted coronary artery, which may cause myocardial ischemia. As well, aortic root surgery such as the Ross procedure and abnomalous coronary artery from pulmonary artery (ACAPA) reimplantation may lead to the same complications. Functional ischemic tests in a combination of three minimum are positive in only 75% of the cases . Silent ischemia due to coronary abnormality is to be detected in those patients. In those patients, coronarography was recommended to be performed at least at 7 and 15 yo, without any clinical symptoms . It has also been recommended to examine those patients at 5, 10 and 15 yo as growth is the main cause for coronary abnormality development. Cardiac CT has been proven to be as efficient as coronarography to depict coronary reimplantation abnormalities . Due to the invasiveness of angiography and to the development of cardiac CT, in our institution, the attitude is to performed cardiac CT instead of angiography with the same frequency in our patients. Coronaro MRI has been established as a valid technique for evaluation of coronary arteries in patients after ASO . The aim of this study is to evaluate if non contrast 3D MR coronarography is as powerful as Cardiac Multislice CT for the depiction of coronary anomalies. All patients, with prior ASO, Ross or ACAPA reimplantation, refereed for cardiac CT and eligible for MRI, over 5yo are included in this prospective multi centric study. Both examinations are performed on the same day after informed consent, from the patient or from both parents if minor. Cardiac CT is performed according to the usual protocol in our institution, and MR coronaro angiography is performed as follow: excluding any contra indication to MR, the study requires one or two maximum 3D true FISP sequence without IV contrast injection, with cardiac gating, and free breathing. 3D images are evaluated blinded to the results of cardiac CT by two senior radiologists, with at least 5 years of experience in MR and CT cardiac imaging. Comparison of the results is consolidated afterwards. Other elements evaluated are tolerance and feasibility of the examination. The study is designed for four years and benefits from a grant from the Assistance Publique-Hopitaux de Paris.

NCT ID: NCT02539940 Completed - Clinical trials for Peripheral Artery Disease

Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment

Apollo
Start date: September 2015
Phase:
Study type: Observational

The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels

NCT ID: NCT02538978 Not yet recruiting - Clinical trials for Critical Limb Ischemia (CLI)

Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System

CLIRST III
Start date: January 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable Rutherford Category 5 critical limb ischemia (CLI). Subjects will be randomized in 3:1 ratio (device treatment: placebo-control).

NCT ID: NCT02535611 Completed - Ischemic Stroke Clinical Trials

Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

EMISO
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The researchers aim to investigate the effect of memantine on stroke outcome in a randomized double-blind placebo-controlled clinical trial.

NCT ID: NCT02533778 Suspended - Ischemic Stroke Clinical Trials

ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

ARISE
Start date: July 2015
Phase: N/A
Study type: Interventional

A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.

NCT ID: NCT02530307 Terminated - Ischemic Stroke Clinical Trials

HT-3951 vs. Placebo in Stroke Rehabilitation

RESTORE
Start date: February 2016
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.

NCT ID: NCT02529202 Completed - Clinical trials for Hypoxic-ischemic Encephalopathy

Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia

Start date: March 2016
Phase: Phase 0
Study type: Interventional

The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic encephalopathy.

NCT ID: NCT02526225 Completed - Ischemic Stroke Clinical Trials

A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.

Start date: February 1, 2016
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

NCT ID: NCT02523261 Completed - Clinical trials for Ischemic Cerebrovascular Accident

Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke

ASTER
Start date: October 10, 2015
Phase: N/A
Study type: Interventional

Mechanical thrombectomy (TM) is now validated through 4 randomized controlled trials of high scientific level as the reference treatment of cerebral infarction associated with proximal cerebral occlusion (MR CLEAN, ESCAPE 2014, 2015). These studies have shown for the first time a major decrease (-35%) of disability related to severe cerebral infarction and reduction in mortality. These studies only used thrombectomy devices called stent retriever for obtaining recanalization rates ranging from 58-72% for the 2 largest studies (MR CLEAN, ESCAPE 2014, 2015). This criterion "recanalization" is important because it largely determines the functional prognosis of patients with severe cerebral infarction (Khatri, 2014). These results are exciting but we can do even better. Indeed, already new thrombectomy devices are available with a special interest for ADAPT (A Direct Aspiration First Pass Technic). This distal suction system, with a high level of endovascular navigability, provides high recanalization rates (> 90%), low morbidity, with a synergistic effect with stent retriever (Turk A, Kowoll 2014 and 2015). To date, these technic (ADAPT) has never been assessed in a randomized controlled trial. We have previously conducted a comparative observational study between two recanalization strategies by thrombectomy using first-line ADAPT or the most widely used stent retriever. The interventional neuroradiologist could, in case of recanalization failure with the Solitaire system, used another thrombectomy material left to the operator's choice. 244 consecutive patients on two centers (Rothschild Foundation, and Foch Hospital, France) admitted for a cerebral infarction associated with proximal occlusion were included. This is so far the largest series of patients with ADAPT system. The complete recanalization rate was 84% with ADAPT versus 68% with stent retriever (P = 0.006). Unpublished data, Oral presentation at the European Stroke Organization, April 2015). Our research aims to show that a first line strategy of recanalization by thrombectomy using a distal suction system (ADAPT) is superior that the use of a stent retriever.