Early real world experience with the CREDO heal stent for elective treatment of intracranial atherosclerotic disease.

Abstract

Intracranial atherosclerotic disease (ICAD) is a major cause of ischemic stroke and transient ischemic attack, particularly in Asian populations. Despite best medical therapy, symptomatic ICAD carries a substantial risk of recurrent ischemia. To evaluate the safety and feasibility of the fibrin-heparin coated CREDO heal stent for the treatment of symptomatic high grade ICAD in routine clinical practice. This retrospective observational case series included patients with symptomatic intracranial stenosis ≥70% treated with the CREDO heal stent. All patients were receiving best medical therapy and had at least one qualifying ischemic event. The primary safety endpoint was stroke, intracranial hemorrhage, or death within 30 days. Secondary endpoints included technical success, angiographic patency, recurrent ischemic events, and functional outcomes measured by the modified Rankin Scale (mRS). Clinical follow-up occurred at discharge, and at 30, 90, and 180 days, with CT angiography at 90 days and DSA at 180 days. Forty-five patients (78% men; mean age 64.8 years) were treated. Technical success was achieved in all cases, with stenosis reduced from 84.5% to ≤30%. No stroke, intracranial hemorrhage, or death occurred within 30 days. Clinical follow-up was complete in all patients at discharge, and at 90 days and 180 days. Imaging follow-up was available in 41 patients at 90 days and in all patients at 180 days, with no angiographic restenosis or stent thrombosis observed. Favorable functional outcome (mRS score ≤2) was observed in all patients at 6 months. In this retrospective series, elective percutaneous transluminal angioplasty and stenting using the CREDO heal stent appeared feasible and showed no major complications in this selected cohort.