Achieva Medical initiated a prospective, multi-center, randomized-controlled clinical trial to evaluate the safety and efficacy of CereStellar™ intracranial assist stent for the treatment intracranial aneurysms in patients. The trial was led by Shanghai Renji Hospital, with Prof. Wan Jieqing as the principal investigator. The first patient was successfully enrolled in early mid-December 2023.
CereStellar™ intracranial assist stent, independently developed by Achieva Medical, is designed based on clinical needs. It utilizes a self-expanding nickel-titanium alloy design compatible with 0.0165/0.017-inch microcatheter delivery and release. The stent's main body features a composite ring design, ensuring both conformability and wall apposition while providing radial support force that better meets clinical requirements. The optional choices for the delivery wire tip provide a more stable release experience for the operator. With multiple radiopaque markers at both ends, the stent is designed to facilitate positioning, release, and identification of the stent expansion effect, aiming to enhance the assistance of spring coil therapy for intracranial aneurysms.
The primary investigator’s evaluation of the first case using the CereStellar™ intracranial assist stent is as follows:
1)The SL-10 delivery wire was used for stent delivery in this case, and it smoothly entered the microcatheter with no resistance during delivery.
2)The stent was clearly visible and accurately positioned during the procedure, with stable release.
3)The stent expanded well during the procedure, conformed to the vessel wall, and overall satisfaction was achieved.