Neqstent coil-assisted flow diverter (NQS) for the treatment of bifurcation aneurysms: The coil-assisted flow diversion safety and performance study (CAFI)

Abstract

Background The Neqstent coil-assisted flow diverter (NQS) is a neck bridging device to facilitate coil occlusion of intracranial aneurysms. CAFI is a prospective, single-arm, multicenter study on the safety and performance of the NQS adjunctive therapy device together with platinum coils for treatment of unruptured intracranial aneurysms. Methods Thirty-eight patients were enrolled. Primary endpoints were occlusion at 6 months for efficacy, and any major stroke or non-accidental death up to 30 days or major disabling stroke within 6 months for safety. Secondary endpoints were re-treatment rate, procedure time, and procedure/device-related adverse events. Procedural and follow-up imaging was reviewed by an independent core laboratory. Adverse events were reviewed and adjudicated by a clinical events committee. Results The NQS was successfully implanted in 36/38 aneurysms, 2/38 in the intention-to-treat group did not receive a NQS and were excluded from follow-up after 30 days. In the per protocol group (PP), 33/36 patients were available for angiographic follow-up. Device related adverse events were recorded in 4/38 (10.5%) patients, one hemorrhagic and three thromboembolic. In the PP group, immediate post-treatment adequate occlusion (RR1 and RR2) was seen in 9/36 (25%) and progressed to 28/36 (77.8%) at 6 months. Complete occlusion (RR1) was achieved in 29/36 (80.6%) at the last available angiogram (3/36 were post procedure). The mean procedure time was 129 min (50-300 min, median 120 min). Conclusion The NQS in conjunction with coils appears to be effective in the treatment of intracranial wide-neck bifurcation aneurysms, but its safety remains to be proved in larger series. Trial registration number NCT04187573.