Boston Scientific (Natick, Massachusetts) said it is ready to launch enrollment of patients with untreated brain aneurysms in its MAPS (Matrix and Platinum Science) trial. It said that the purpose of the MAPS trial is to identify and investigate relevant endpoints for evaluating the efficacy and durability of endovascular treatment of brain aneurysms with the coil devices.
The trial is a prospective multi-center study designed to randomize about 600 patients at 50 centers for treatment of brain aneurysms. Patients will be randomized to receive either its Matrix2 Detachable Coils or Guglielmi Detachable Coils (GDCs), which are both FDA-approved.
“The GDC coils are the first bare-platinum detachable coils cleared for aneurysm treatment and the Matrix2 coils, which are sort of our next-generation coils, are covered with a polyglycolic-polylactic acid bio-polymer and that’s been shown to increase treatment durability, at least in preclinical studies,” Eric Olson, a spokesperson for Boston Scientific, told Medical Device Daily.
Primary endpoints of the study are expected to be completed in early 2009, and secondary endpoints could be complete by early 2013, he said.
“By including both technologies in the study, we will establish a baseline of data to support future research involving endovascular treatment of aneurysms with bare platinum and bio-polymer covered coils,” said Milt McColl, president of Boston Scientific Neurovascular.
Olson added that the trial has garnered a lot of support in the industry because it is the first of its kind.
“Today, physicians rely on visual interpretation of angiographic images and other subjective methods to judge the success of coiling procedures,” said Stanley Barnwell, MD, PhD, associate professor of neurological surgery and the Dotter Interventional Institute Oregon Health and Sciences University , and a member of the MAPS trial steering committee. “The MAPS trial is designed to identify clinically relevant endpoints that can be used to validate, or invalidate these clinical proxies and determine new, more empirical ways to measure the success of these innovative procedures.”
A brain aneurysm is a weakened bulge in the wall of an artery in the brain. According to Boston Scientific, it is estimated that up to one in 15 people in the U.S. will develop a brain aneurysm during their lifetime.
When a brain aneurysm ruptures, it can bleed into the subarachnoid space around the brain causing a subarachnoid hemorrhage (SAH). The prevalence of SAH in the U.S. exceeds 30,000 people each year, and half those patients die as a result of the rupture, Boston Scientific said. Of those who survive, about half will suffer permanent physical or mental disability.
Endovascular coiling is a newer, less-invasive treatment option for brain aneurysm patients than conventional surgical clipping because it does not require open surgery. Instead, physicians use a real-time X-ray technology, called fluoroscopy, to visualize the patient’s vascular system and access the aneurysm from within the artery itself.
To perform the procedure, a microcatheter is inserted into an artery in the patient’s leg and navigated through the vascular system, up into the head and into the aneurysm. Then, tiny coils are fed through the microcatheter and deployed within the aneurysm to block the flow of blood and prevent it from rupturing.
The coils are made of platinum so they are visible under fluoroscopy and pliable enough to conform to the aneurysm shape. More than 200,000 patients worldwide have been treated with detachable platinum coils, according to Boston Scientific.