Carotid artery disease is one of the leading causes of stroke and it is the target of an innovative multi-center clinical trial led by Dr. Philip Meyers here at Columbia University Medical Center/New York Presbyterian Hospital.
Carotid artery disease is caused by the gradual build up of plaque, a waxy substance that sticks to the inside of the carotid arteries.
These arteries (there are four of them; one pair on each side of your neck) are the main supply of blood to the brain. When plaques form in these arteries, the brain is at risk for two reasons: the artery can become completely blocked by the plaque, cutting off blood supply to the brain; or pieces of the plaque can naturally dislodge and block smaller blood vessels within the brain.
The surgical methods traditionally used to remove these plaques are endarterectomy and angioplasty with stenting.
With carotid endarterectomy, surgeons make a large incision in the neck, open the artery and remove the plaque directly (see image at right).
The other method is called carotid artery angioplasty with stenting (image below left); this is a minimally invasive procedure where a very small hollow tube, or catheter, is advanced from a blood vessel in the groin to the carotid arteries. Once the catheter is in place, a balloon may be inflated to open the artery and a stent is placed. A stent is a cylinder-like tube made of thin metal-mesh framework used to hold the artery open. Because there is a risk of stroke from bits of plaque breaking off during the procedure, an apparatus, called an embolic protection device, may be used. This device is a filter (like a small basket) that is attached on a guide-wire to catch any debris that may break off during the procedure.
With both angioplasty with stenting and the afore mentioned endarterectomy procedure, there is a small risk, despite precautions used, that pieces of plaque will break off and travel to the brain. For this reason, specialists like Dr. Meyers from the Endovascular Center are always looking for safer ways to remove these plaques, and improve patient outcome.
In this effort, Dr. Meyers is principle investigator here at Columbia for one leg of a multi-center clinical trial testing new technology developed by the company Silk Road Medical. This phase III trial, called ROADSTER, employs an entirely new way to remove carotid artery plaque:
A small incision is made at the base of the neck to access the carotid artery. A tiny vacuum of-sorts is inserted into the artery to temporarily reverse the flow of blood. This way, while a stent is put in place, any plaque that might break off is quickly pulled in the opposite direction of the brain and then run through a filter. Blood flows through this filter and is returned to the body through an artery in the leg.
The technology used here is called the MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) and the purpose of the ROADSTER trial is to further test the safety and efficacy the device. It is being used, “in conjunction with an FDA approved carotid artery stent for the treatment of carotid artery disease” according to the study’s page on clinicaltrials.gov.
The temporary reversal of blood flow in the artery is safe as the brain has multiple sources of blood that can deliver oxygen to the brain throughout the procedure.
On August 13, 2013, Dr. Meyers along with vascular surgeon Dr. Nicholas J. Morrissey and interventional cardiologist Dr. Anthony L. Pucillo were the first in New York City to use this device on a patient as part of the ROADSTER trial.
Dr. Meyers’s group at Columbia is one of 19 centers across the United States and Spain treating patients in this trial. In total, about sixty patients have been enrolled so far. A representative from Silk Road Medical says they plan to have at least 20 sites in total.
You can learn more about this trial here.
* Images courtesy of Silk Road Medical.
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