Topics

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

2019-09-25 06:13:38 | BioPortfolio

Summary

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.

Study Design

Conditions

Stroke, Ischemic

Intervention

Neurothrombectomy

Location

Hospital Vall d'Hebron
Barcelona
Spain
08035

Status

Not yet recruiting

Source

Anaconda Biomed S.L.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-25T06:13:38-0400

Clinical Trials [2458 Associated Clinical Trials listed on BioPortfolio]

Registry for Evaluating Outcome of Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy.

The Bernese-European RegistrY for ischemic stroke patients treated Outside current guidelines with Neurothrombectomy Devices using the SOLITAIRE™ FR With the Intention For Thrombectomy (...

Post‐Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia

The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patient...

WOLF - Feasibility Neurothrombectomy Study in Acute Ischemic Stroke Patients

This study is being conducted as a feasibility clinical investigation to collect safety and technical performance data of the WOLF Thrombectomy Device for the removal of thrombus in the ne...

INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE

China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases a...

Neopterin and Ischemic Stroke

Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of death and disability in industrial world. Inflammation has been reported to constitute a major co...

PubMed Articles [2582 Associated PubMed Articles listed on BioPortfolio]

The introduction of ticagrelor is associated with lower rates of recurrent ischemic stroke after myocardial infarction.

Previous ischemic stroke is a predictor of recurrent ischemic stroke after an acute myocardial infarction (AMI). Dual antiplatelet therapy, including a P2Y12-inhibitor, is important in secondary preve...

Development of research on mechanisms of acupuncture intervention and relationship between astrocyte and ischemic stroke.

Astrocytes are the most abundant cells in the central nervous system, which has been demonstrated to be one of the targets for the treatment of ischemic stroke. Many studies have confirmed that acupun...

Processes of Care Associated With Risk of Mortality and Recurrent Stroke Among Patients With Transient Ischemic Attack and Nonsevere Ischemic Stroke.

Early evaluation and management of patients with transient ischemic attack (TIA) and nonsevere ischemic stroke improves outcomes.

Five-year readmission and mortality differ by ischemic stroke subtype.

Ischemic stroke subtype may influence the risk of readmission and mortality after ischemic stroke (IS) and transient ischemic attack (TIA) due to differences in comorbidity, risk factors, and stroke s...

A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke.

The use of intensive lipid-lowering therapy by means of statin medications is recommended after transient ischemic attack (TIA) and ischemic stroke of atherosclerotic origin. The target level for low-...

Medical and Biotech [MESH] Definitions

The application of repeated, brief periods of vascular occlusion at the onset of REPERFUSION to reduce REPERFUSION INJURY that follows a prolonged ischemic event. The techniques are similar to ISCHEMIC PRECONDITIONING but the time of application is after the ischemic event instead of before.

A drug combination of aspirin and dipyridamole that functions as a PLATELET AGGREGATION INHIBITOR, used to prevent THROMBOSIS and STROKE in TRANSIENT ISCHEMIC ATTACK patients.

Ischemic injury to the OPTIC NERVE which usually affects the OPTIC DISK (optic neuropathy, anterior ischemic) and less frequently the retrobulbar portion of the nerve (optic neuropathy, posterior ischemic). The injury results from occlusion of arterial blood supply which may result from TEMPORAL ARTERITIS; ATHEROSCLEROSIS; COLLAGEN DISEASES; EMBOLISM; DIABETES MELLITUS; and other conditions. The disease primarily occurs in the sixth decade or later and presents with the sudden onset of painless and usually severe monocular visual loss. Anterior ischemic optic neuropathy also features optic disk edema with microhemorrhages. The optic disk appears normal in posterior ischemic optic neuropathy. (Glaser, Neuro-Ophthalmology, 2nd ed, p135)

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

Restoration of blood supply to tissue which is ischemic due to decrease in normal blood supply. The decrease may result from any source including atherosclerotic obstruction, narrowing of the artery, or surgical clamping. It is primarily a procedure for treating infarction or other ischemia, by enabling viable ischemic tissue to recover, thus limiting further necrosis. However, it is thought that reperfusion can itself further damage the ischemic tissue, causing REPERFUSION INJURY.

More From BioPortfolio on "Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke"

Quick Search

Relevant Topic

Acute Coronary Syndromes ACS
Acute Coronary Syndromes (ACS) is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked. Treatment for acute coronary syndrome includes medicines and a procedure known as angioplasty, during which doctors inflat...


Searches Linking to this Trial