POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE. The ROADSTER 2 Study

Submitted by shcAdmin on Wed, 12/19/2018 - 15:47
Study ID
00736
Status
Participant Ages
18+
Accepting Healthy Volunteers
Study Information

You are a candidate for this study if you have Carotid Artery Disease. 
Your carotid arteries are a pair of blood vessels in your neck that carry blood from your heart to your head and brain. These vessels can become narrowed or blocked by a buildup of plaque called a stenosis. A stenosis may lead to a stroke, which happens when blood flow to a part of the brain is stopped. A stroke is sometimes called a “brain attack.” If blood flow is stopped for longer than a few seconds, the brain cannot get 
blood and oxygen. Brain cells can die, causing permanent damage.

The most common treatment for severe carotid artery disease is a 
surgery called Carotid Endarterectomy (CEA). Your surgeon will make an incision on 
your neck to access the affected artery, open it and remove the plaque. Your surgeon will then close the artery and the incision in your neck using stitches. 

There are situations where a CEA cannot be performed, for example if you have other health conditions that make surgery too risky. Another option is a procedure called transfemoral carotid angioplasty and stenting (CAS). This minimally invasive alternative allows your physician to complete the procedure through a tube placed into the artery in your thigh. 

First, a protection device is placed next to the diseased area of the vessel, to help prevent any pieces of plaque from traveling towards your brain. Then, a small balloon is advanced to the narrowed part of your artery. Your surgeon will inflate the balloon, compressing the plaque, and then place a small elastic-like scaffold tube called a stent in order to cover the plaque and keep the artery open. Widening the narrowed 
portion of the artery may reduce the risk of stroke in the future. 

The TCAR Procedure 

A potential complication of both surgery and stenting is a stroke during the procedure itself. Studies have shown a higher risk of stroke during stenting as compared to 
surgery. The TCAR Procedure using the ENROUTE® Transcarotid Neuroprotection System is designed to reduce the risk of stroke while inserting the ENROUTE Transcarotid Stent. The TCAR procedure is performed through a small incision at your neckline just above your clavicle. This incision is much smaller than a typical CEA incision. 

Your surgeon will place a tube directly into your carotid artery and connect it to a system that will direct blood flow away from your brain, to protect against plaque that may come loose reaching your brain. Your blood will flow through the system and any material will be captured in a filter. Your filtered blood will then be returned through a 
second tube in your upper leg. After the stent is placed successfully, flow reversal is turned off and blood flow resumes in its normal direction.
 

Physician
Contact Information

Jennifer Lambert
Nurse Practitioner Division of Vascular and Endovascular Surgery
617-789-2225
Jennifer.lambert@steward.org
 

Purpose of Trial
If you have carotid artery disease and your physician has told you that you are at high risk for surgical treatment (carotid endarterectomy), you
may be wondering what that means and what options you have. Several factors may increase the risk of surgery, including age and medical conditions you may suffer from. If you meet one or more of these criteria, your physician may tell you that you are eligible to participate in a clinical trial for the TCAR Procedure- TransCarotid Artery
Revascularization
Sponsor
Eligibility

Male and female patients at least 18 years of age with either symptomatic carotid artery stenosis equal to or greater than 50% OR asymptomatic carotid artery stenosis equal to or greater than 80% determined by duplex ultrasound, CT/CTA, MR/MRA or angiography to be: 

A complete vascular evaluation is required due to may medical and anatomical inclusion and exclusion criteria.

No healthy volunteers will be considered.