Mechanical detachable platinum coil: Report of the European phase II clinical trial in 60 patients

PURPOSE: To determine the safety and reliability of the mechanical detachme nt system of a platinum coil (Detach-18) when used for neurovascular emboli zation. MATERIALS AND METHODS: Sixty patients (21 men, 39 women; age range, 26-75 y ears; mean age, 56.2 years) were treated in seven centers. Ease of introduc tion of the coil to the microcatheter, effect of coil passage on the microc atheter shape and stability during its delivery, retrievability of the toil before and after the transition zone passed beyond the microcatheter, deta chment of the toil, and effect of coil rotation on the microcatheter stabil ity were evaluated. The detachment system itself was evaluated for prematur e detachment, failure of the coil to detach, detachment time, number of tur ns, visibility of radiopaque markers, number of coils deployed per patient, and percentage of vessel occlusion obtained. A 0.015-inch-diameter regular coil and a 0.014-inch-diameter soft coil were used. RESULTS: A total of 1,061 coils were used; 1,009 were detached. The number of coils deployed ranged from four to 104 (mean, 17 coils). The coils passe d easily through the microcatheter. The detachment maneuver occurred within 5-25 seconds, with five to 60 turns of the introducing wire. One premature coil detachment occurred without clinical sequela; 100% occlusion of the v essel lumen was achieved in 53 patients; 89%-90%, in four; and 70%-80%, in two. There were no device-related complications. CONCLUSION: The detachment system was safe and reliable. This is a useful s ystem for coil embolization in neurovascular diseases.