Boston Scientific Corporation has announced that enrollment has begun in its MAPS clinical trial.
The MAPS trial (Matrix And Platinum Science) is designed to identify and investigate clinically relevant endpoints for evaluating the efficacy and durability of endovascular treatment of brain aneurysms. Patients will be randomized to receive either Matrix2(R) Detachable Coils or GDC(R) Detachable Coils. Boston Scientific manufactures GDC coils, the first bare-platinum detachable coil cleared for aneurysm treatment, as well as Matrix2 coils, which are covered with a polyglycolic- polylactic acid (PGLA) bio-polymer shown to improve treatment durability in preclinical studies.
The trial's primary endpoint is target aneurysm recurrence (TAR), which is a composite endpoint comprised of target aneurysm reintervention, target aneurysm rupture or re-rupture or death. The first patient was enrolled and treated on March 29 at the Healtheast Neurovascular Institute, St. Joseph's Hospital in St. Paul, MN by Michael Madison, M.D., and James Goddard M.D., who will be joined in the trial by partners Jeff Lassig, M.D., and Mark Myers, M.D. The MAPS trial is a prospective, multi-center study that is designed to randomize approximately 630 patients at 50 global centers for treatment of brain aneurysms.
"It is gratifying to achieve this milestone of first patient enrollment," said Cameron McDougall, M.D., Chief, Endovascular Neurosurgery, Barrow Neurological Institute, and Co-Principal Investigator of the MAPS Trial. "Not only is this trial important in its own right, but it further demonstrates that multidisciplinary aneurysm trials can and will help define the future of aneurysm treatment."