Introduction: We report the results of a prospective clinical study using a new self-expanding nitinol stent (Enterprise) designed for the treatment of wide-necked intracranial aneurysms.
Methods: We treated 31 saccular, wide-necked intracranial aneurysms in 30 patients. Ten aneurysms had recanalized after prior endovascular treatment without a stent, and 21 aneurysms had not been treated before.
Results: Stent deployment was successful in all procedures. Additional coil embolization was performed in all aneurysms. Initial complete angiographic occlusion was achieved in 6 aneurysms, a neck remnant was left in 18 aneurysms and there were 7 residual aneurysms. Angiographic follow-up examinations of 30 lesions after 6 months demonstrated 15 complete occlusions, 8 neck remnants and 7 residual aneurysms. One patient refused the 6-month angiographic follow-up. Spontaneous occlusion of the aneurysm had occurred in 14 patients, and 6 aneurysms showed recanalization. Four of these residual aneurysms were retreated. At the 6-month follow-up, 29 parent arteries were unaffected, whereas two parent vessels demonstrated minor asymptomatic narrowing at the stent site. Two patients experienced one or more possible or probable device-related serious adverse events during the 6-month follow-up period. There was no procedural morbidity or mortality at 6 months after the procedure.
Conclusion: The reported results demonstrated the safety and feasibility of the Cordis Neurovascular Enterprise stent in the treatment of wide-necked intracranial aneurysms. Initial clinical and angiographic results are favorable.