Boston Scientific Announces Completion of Enrollment in Aneurysm Coiling Clinical Trial
Boston Scientific Corporation announced that it has completed enrollment in its MAPS(TM) clinical trial, which is studying the coiling of intracranial aneurysms. This prospective, randomized trial commenced enrollment in 2007 and has reached its goal of 630 patients, enrolled at 47 hospitals in 11 countries. Principal investigators for the trial are Anil Gholkar, O.B.E., M.B.B.S.,Clay Johnston, M.D., Ph.D., andCameron McDougall, M.D.
The MAPS trial compares clinical outcomes in patients treated with either bare-platinum GDC(R) Detachable Coils or Matrix2(R) Detachable Coils, which are covered with a bio-polymer. The primary endpoint is Target Aneurysm Recurrence (TAR) at one year, a composite clinical endpoint of target aneurysm rupture or re-rupture, re-treatment or neurologic death. Secondary angiographic endpoints will be compared to the primary clinical outcomes over several years to evaluate the long-term predictive value of 12-month angiography.
"The MAPS trial has significant potential to enhance our understanding of the products we use to treat intracranial aneurysms as well as our methods for assessing outcomes," said Dr. Gholkar. "By conducting rigorous measurement, monitoring and adjudication of clinical outcomes over multiple years, the MAPS trial will establish a critical baseline from which to judge existing treatments as well as future endovascular technologies."
Aquilla Turk, D.O., is the Chairman of the MAPS Steering Committee and enrolled the final patient in the trial. "With enrollment completed, our focus now turns to data monitoring, completion of follow up and preparation for primary endpoint publication in 2011," said Dr. Turk. "The Steering Committee is grateful to all the trial investigators who have worked so diligently to reach this milestone."
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