A new self-expanding nitinol stent (Enterprise) for the treatment of wide-necked intracranial aneurysms:: initial clinical and angiographic results in 31 aneurysms

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.