Balt International has enrolled first patient in Marco Polo, a multicenter randomized trial on selective endovascular aneurysm occlusion with coils versus parent vessel reconstruction using the Silk flow diverter.
Balt said that the trial will enroll 160 patients split evenly between the control and test arms at a maximum of 20 sites (Europe and Canada). The primary study objective is to demonstrate the safety and effectiveness of the Silk Artery Reconstruction Device compared to the standard treatment of endovascular coiling, with the aid of balloon remodeling or stenting when appropriate.
The study population is expected to consist of patients presenting un-ruptured saccular aneurysms sized between 7 and 15 mm located in the Supraclinoid Carotid Artery, or the vertebro- basilar system.
Balt International said that the primary endpoint is the difference in the Angiographic Occlusion rate between the two groups at 12 months following implant. Secondary endpoints include peri-procedural adverse events and adverse events post-procedure and at 12-months follow-up.
The Silk Artery Reconstruction Device consists of an auto-expansible stent and a delivery system. The Silk prosthesis is made of nitinol braided wires with radiopaque wires integrated within the netting to enable visualisation under X-rays. Its ends are slightly flared to optimise expansion. The Silk stent has been commercially available in over 30 countries since 2008 and it has been used in about 1600 procedures.
Jacques Moret, professor of Fondation Rothschild Hospital in Paris and the coordinating principal investigator of the trial, said: “We believe that the use of densely braided stents, like Silk, is changing the approach to aneurysm treatment. This trial will provide important information on the effectiveness of this option, compared to what we have been doing until recently.”
Nicolas Plowiecki, president and CEO of Balt, said: “We are excited to take the Silk stent into this pivotal trial. We expect that clinical data from this study will show positive benefits for patients, and will open the way to a new approach to the disease.”