SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

2014-08-27 03:16:27 | BioPortfolio


The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Ischemic Stroke


SOLITAIRE™ Device compared to MERCI® Device


Oregon Stroke Center
United States




ev3 Endovascular, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:16:27-0400

Clinical Trials [5485 Associated Clinical Trials listed on BioPortfolio]

Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

The primary objectives of the Multi MERCI trial were: - to evaluate the addition of the Merci L5 Retriever - additionally permit use of the Merci Retrieval System in the setting of...

Ischemic Conditioning by Aircrews for Refractory Occlusions

The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perf...

EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic Stroke

The primary aim of Registrap study is to assess the safety and effectiveness of the EmboTrap®II Clot Retriever device (Neuravi) in patients with acute ischemic stroke from large vessel oc...

Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3

This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days wh...

Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy

The purpose of this study is to compare the effectiveness of treating acute ischemic stroke with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours of s...

PubMed Articles [6263 Associated PubMed Articles listed on BioPortfolio]

Use of a NobleStitch™ EL Device for PFO Closure.

Cryptogenic stroke is the final diagnosis in almost 40% of ischemic acute cerebrovascular events. There is currently no definitive clinical evidence that percutaneous closure of patent foramen ovale (...


Recent trials established the efficacy of mechanical stent-retriever thrombectomy for treatment of stroke patients with large vessel occlusion (LVO) in the anterior circulation. However, stent-retriev...

Patent Foramen Ovale and Cryptogenic Stroke or Transient Ischemic Attack: To Close or Not to Close? A Systematic Review and Meta-Analysis.

The optimal strategy of secondary stroke prevention in patients with patent foramen ovale (PFO) is controversial. This study was performed to evaluate the efficacy and safety of the device closure (DC...

Targeted Temperature Management: Peltier's Element-Based Focal Brain Cooling Protects Penumbra Neurons from Progressive Damage in Experimental Cerebral Ischemia.

Targeted temperature management (TTM), or therapeutic hypothermia, is one of the most potent neuroprotective approaches after ischemic and traumatic brain injuries. TTM has been applied clinically wit...

Acute ischemic dissection of an "S"-shaped carotid artery: The "one-stop" value of using a detachable Solitaire AB stent.

This study aimed to evaluate the efficacy and safety of endovascular repair using detachable Solitaire AB stents for acute ischemic dissection of "S"-shaped carotid arteries. From May 2015 to December...

Medical and Biotech [MESH] Definitions

Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.

Device designed to wear externally to support muscular skeletal system in various movements such as RANGE OF MOTIONS; WEIGHT-BEARING; GAIT; and LOCOMOTION.

Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.

The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.

Removal of an implanted therapeutic or prosthetic device.

More From BioPortfolio on "SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study"

Quick Search


Relevant Topics

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial