Navigation Links
UH Case Medical Center among first to enroll patients for global carotid artery trial

Physicians at University Hospitals Case Medical Center enrolled their first patients in the ROADSTER Study, a global, multicenter clinical trial evaluating a novel, less-invasive procedure to help clear blockages in carotid arteries and prevent strokes.

Every year, more than 300,000 people in the United States are diagnosed with blockages, or plaques in their carotid artery. If left untreated, these blockages can slow or even stop blood flow to the brain, causing a potentially disabling stroke, also known as a "brain attack."

Current treatment options include an open surgery known as carotid endarterectomy (CEA) and a minimally invasive alternative known as carotid artery stenting (CAS). Both procedures have been shown to effectively treat the blockage and reduce a patient's risk of stroke. However, each option has limitations for patients. CEA involves a large incision along the neck and carries a risk of surgical complications. CAS is less invasive, but in some studies, has not been as effective in preventing strokes as CEA.

The ROADSTER trial is investigating the safety and efficacy of the Silk Road System, in high surgical risk patients. The new system is designed to combine the advantages of both CEA and CAS in a procedure called Transcarotid Stenting with Dynamic Flow Reversal, also known as the Silk Road procedure.

Vik Kashyap, MD, Division Chief of Vascular Surgery at UH Case Medical Center's Harrington Heart & Vascular Institute and Professor of Surgery at Case Western Reserve University School of Medicine, is leading the trial for the hospital which was selected as one of 25 centers around the world participating. The trial, which is expected to enroll 140 patients, is intended to support FDA clearance of the Silk Road system in the U.S.

"The potential to treat carotid disease with a less invasive method that potentially offers the same safety profile as traditional surgery is exciting," said Dr. Kashyap. "Our goal is to treat the blockage with as little procedural risk as possible so that our patients can return to full and productive lives."

The innovative procedure draws upon proven surgical techniques to protect the brain from stroke risk during carotid stenting. It allows physicians to deliver a stent directly from the neck, offering a potentially safer delivery route than the groin, which is typically used in CAS procedures. Another unique aspect of the system is the ability to temporarily reverse blood flow during the procedure to ensure the patient's brain is fully protected at all times. The Silk Road procedure is minimally invasive and can be performed using local anesthesia.

In a European study (PROOF) performed last year, the Silk Road procedure demonstrated encouraging results. In a population of 75 patients, the results closely matched the outcomes demonstrated in numerous CEA studies and were better than the stroke outcomes reported in several CAS studies. The PROOF study also used a sensitive imaging test to determine how well the Silk Road System protected the brain from tiny plaque debris that can be displaced during CEA and CAS treatment and lodge in the brain. The imaging analysis indicated that the Silk Road system provided impressive neuroprotection, with a very low rate of localized brain injury.

"This procedure is first-of-its-kind in combining the safety advantages of traditional surgery with the more patient-friendly advantages of stenting," said Dr. Kashyap. "The reason we treat the neck is to prevent stroke but the biggest risk of the traditional procedures was causing a stroke during the operation from plaque breaking off and getting to the brain. This device significantly minimizes that risk and potentially could lead us to finding a new treatment alternative."

The study is funded by Silk Road Medical, developers of the transcarotid stenting with dynamic flow reversal system.


Contact: Mike Ferrari
University Hospitals Case Medical Center

Related medicine news :

1. Physician Groups Call for Fewer Medical Tests
2. Weill Cornell Medical College establishes Center for Healthcare Informatics and Policy
3. CAM therapy combined with conventional medical care may improve treatment of lower back pain
4. Image share project gives patients and physicians anytime, anywhere access to medical images
5. Researchers determine vitamin D blood level for reducing major medical risks in older adults
6. Biomedical researchers receive Hartwell Foundation awards
7. Columbia University Medical Center and NY-Presbyterian experts at APA meeting
8. Fitness in Middle Age Lowers Medical Costs Later: Study
9. Ben-Gurion U. and Cincinnati Childrens Hospital to develop pediatric-specific medical technologies
10. Gene Tests May Not Drive Patients to More Medical Care
11. University studies and career expectations of medical students
Post Your Comments:
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... In an ... Resurrection Medical Center (RMC) in Chicago, IL, UV Angel is evaluating the efficacy of ... and surgical intensive care units (totaling 30 beds) from May 2014 through October 2015 ...
(Date:11/25/2015)... ... , ... Today, Mothers Against Drunk Driving (MADD) learned that the ... the first time since 2011. In 2014, there were 9,967 fatalities involving an alcohol ... National Highway Traffic Safety Administration (NHTSA), 32,675 people were killed in traffic crashes in ...
(Date:11/25/2015)... ... November 25, 2015 , ... In honor of ... Pioneers, individuals and groups responsible for advancing care for pulmonary hypertension (PH) patients ... by the public, will receive special recognition throughout 2016 as part of PHA’s ...
(Date:11/25/2015)... ... November 25, 2015 , ... Privately owned Contract ... significant expansion of its current state of the art research, development and manufacturing ... to increase its manufacturing capacity as well as to support its clients’ growing ...
(Date:11/25/2015)... ... November 25, 2015 , ... Many people know of the common ... cold hands, and dry skin. But many people who find their cholesterol levels and ... instead of their thyroid, especially if they don’t have any of the other symptoms. ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... , Nov. 24, 2015  Array BioPharma Inc. ... Chief Executive Officer, Ron Squarer , will ... in New York.  The public is welcome to ... the Array BioPharma website.Event:Piper Jaffray Annual Healthcare ConferencePresenter:  ... December 2, 2015Time:1:30 p.m. Eastern Time Webcast: ...
(Date:11/24/2015)... , Nov. 24, 2015  DILON Diagnostics and ... signed an agreement for DILON to distribute GE,s Discovery ... the globe. The signing of this distribution agreement will provide ... Molecular Breast Imaging system and is considered an initial ... better healthcare solutions for clinicians and their patients. ...
(Date:11/24/2015)... November 24, 2015 ... adds Latest Guidebook for Chinese Medical ... pages published in November 2015 to the medical ... intelligence library at . ... fastest growing global economies with a fifth population ...
Breaking Medicine Technology: