Background and objective Stent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial.
Method The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints.
Results 30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths.
Conclusion The Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort.
Clinical trial.gov registration number NCT0234058;Results
- atlas stent
- cerebral aneurysm
- stent-assisted coiling
- wide-neck aneurysm
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BTJ and OOZ contributed equally.
Contributors All authors contributed to the final draft with revisions, edits, and contents and also participated in enrolling subjects.
Funding This work was sponsored by Stryker Neurovascular, Fremont, California, USA.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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