Comparison of pEGASUS-HPC and CREDO Heal stent systems deployed via NeuroSpeed percutaneous angioplasty balloon catheter for treatment of acute symptomatic intracranial stenosis and occlusion.

PURPOSE: To compare the efficacy and safety of the pEGASUS-HPC and CREDO heal coated stent systems used with the NeuroSpeed percutaneous angioplasty (PTA) balloon catheter, for treating acute symptomatic intracranial artery stenosis (ICAS) with or without acute vessel occlusion (VO).

METHODS

This retrospective, multicenter study included patients with ICAS between June-2021 and June-2024 treated with the NeuroSpeed PTA balloon catheter and either stent system. Clinical endpoints included National Institutes of Health Stroke Scale (NIHSS) scores and modified ranking scores (mRS), safety and efficacy endpoints included in-stent thrombosis and in-stent stenosis.

RESULTS

Sixty-nine patients were included (pEGASUS-HPC, n = 34; CREDO heal, n = 35). Both groups showed significant improvement in arterial diameter post-intervention (pEGASUS-HPC: 0.47 mm (SD 0.27 mm) to 1.69 mm (SD 0.55 mm); CREDO heal: 0.57 mm (SD 0.41 mm) to 1.89 mm (SD 0.62 mm)). Revascularization success, defined as residual stenosis < 50%, was achieved in 32/34 (93.9%) patients in the pEGASUS-HPC group and 33/35 (94.3%) in the CREDO heal group. In-stent re-stenosis occurred in 5/34 (14.7%) of patients in the pEGASUS-HPC group and 2/35 (5.7%) in the CREDO heal group and retreatment with PTA was performed in 3/34 (8.8%) and 2/35 (5.7%), respectively. Peri- or postprocedural in-stent thrombosis occurred in 3/34 (8.8%) of patients in the pEGASUS-HPC group and 2/35 (5.7%) in the CREDO heal group. At 3-6 months, the proportion of patients achieving an mRS score of 0-2 was 25/34 (73.5%) in the pEGASUS-HPC group and 28/35 (80.0%) in the CREDO heal group (p = 0.578).

CONCLUSION

Both stent systems proved effective and safe, showing significant post-intervention arterial dilation, high revascularization rates, and similar functional outcomes (mRS 0-2 at 3-6 months), though they differed in in-stent restenosis rates.