login
  Password reminder
NeuroNews
Contact the editor Visit NeuroNews Twitter feed Visit NeuroNews Facebook page
 

First patient enrolled in SCAFFOLD clinical study for carotid stenting


Thursday, 12 Sep 2013 10:09
Claudio Schönholz
Claudio Schönholz

Gore has announced that it has enrolled the first patient in its Carotid stent clinical study for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy (SCAFFOLD). The patient was successfully treated by Claudio Schönholz and his team at the Medical University of South Carolina in Charleston, USA.


“The first procedure using the Gore carotid stent was successful and the patient is doing well, having left the hospital the next day. Studies like this will further our understanding of optimal patient outcomes in carotid artery stenosis,” Schönholz said. “The new Gore device is designed to be flexible, offer plaque retention and stabilisation benefits, and along with bound heparin may provide advantages for improved patient outcomes.”

SCAFFOLD is a multicentre, single-arm, prospective study comparing the Gore carotid stent to a performance goal developed from carotid endarterectomy outcomes. The investigational study will include up to 50 sites in the US and will enrol approximately 312 patients. Co-principal investigators are Peter Schneider, Kaiser Permanente Medical Center, Honolulu; and William Gray, Columbia University Medical Center, New York.

“In times of uncertainty regarding optimal treatment for patients with high surgical risks, it is important to evaluate unique treatment options,” said Schneider.

Leveraging more than 35 years of clinical experience with expanded polytetrafluoroethylene (ePTFE), the Gore carotid stent is a next-generation device designed to integrate innovative material to trap arterial plaque against the vessel wall, while yielding maximised flexibility of the stent in order to conform to the often tortuous anatomy of carotid vasculature. The new Gore device combines the flexible properties of a traditional open-cell, nitinol stent design with a 500 micron pore size ePTFE lattice which offers the plaque retention and stabilisation benefits traditionally seen in a closed cell stent design. Additionally, the permanently bound heparin may offer a local advantage seen with other Gore devices that utilise bound heparin.

“Gore is committed to continuing development of innovative solutions for patients in order to improve their quality of life,” said Ben Beckstead, associate with the Gore Medical Division Peripheral Interventional Business. “The Gore SCAFFOLD clinical study will bring us one step closer to a new solution for improving patient outcomes, while simultaneously generating data for consideration of Medicare reimbursement for such procedures.”




Add New Comment

Related Items


Most popular


Next generation Medina coil system shows improvements in early human experience
Thursday, 26 Feb 2015
In early use of the Medina coil system, researchers have found the device to be a next generation coil that combines the familiar procedural safety and technique associated with conventional coils, ... Next generation Medina coil system shows improvements in early human experience

Better outcomes observed in MR CLEAN non-general anaesthesia subgroup in post-hoc analysis
Thursday, 02 Apr 2015
In a post-hoc analysis of the use of general anaesthesia in the MR CLEAN trial (Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands) ... Better outcomes observed in MR CLEAN non-general anaesthesia subgroup in post-hoc analysis

Cover device proves more effective than guide catheter in stroke model
Wednesday, 18 Mar 2015
In an in vitro stroke model comparison, the use of the Cover accessory device (Lazarus Effect) in conjunction with a stent retriever resulted in higher successful recanalisation rates, no embolic ... Cover device proves more effective than guide catheter in stroke model

Features


New day in acute ischaemic stroke therapy
Friday, 17 Apr 2015
The newest generation of trials for acute ischaemic stroke, including MR CLEAN, ESCAPE, EXTEND IA and SWIFT PRIME, appear to have ushered in a new era in stroke therapy. Now, Joseph Broderick (... New day in acute ischaemic stroke therapy

Flow diverter technology for intracranial aneurysms
Tuesday, 31 Mar 2015
Gabor Toth writes for NeuroNews about the flow diverters that are currently available and the ongoing clinical trials that could have the potential to extend the indications of flow diverter therapy ... Flow diverter technology for intracranial aneurysms

Profiles


Joseph Broderick
Wednesday, 07 Jan 2015
Joseph Broderick speaks to NeuroNews about the future of neurology and his research, in particular, ... Joseph Broderick

Vladimír Beneš Jr
Tuesday, 30 Sep 2014
Vladimír Beneš Jr is professor and chair at the First Medical School, Charles University, P... Vladimír Beneš Jr

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
 
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions