Mechanical detachable platinum coil: report of the European phase II clinical trial in 60 patients.
OBJECTIVE
To determine the safety and reliability of the mechanical detachment system of a platinum coil (Detach-18) when used for neurovascular embolization.


METHODS
Sixty patients (21 men, 39 women; age range, 26-75 years; mean age, 56.2 years) were treated in seven centers. Ease of introduction of the coil to the microcatheter, effect of coil passage on the microcatheter shape and stability during its delivery, retrievability of the coil before and after the transition zone passed beyond the microcatheter, detachment of the coil, and effect of coil rotation on the microcatheter stability were evaluated. The detachment system itself was evaluated for premature detachment, failure of the coil to detach, detachment time, number of turns, 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 passed 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 vessel lumen was achieved in 53 patients; 80%-90%, in four; and 70%-80%, in two. There were no device-related complications.


CONCLUSIONS
The detachment system was safe and reliable. This is a useful system for coil embolization in neurovascular diseases.
Murphy
K J
KJ
Div of Diagnostic and Interventional Radiology, Geneva Univ Hospital, Switzerland. kmurphy@jhmi.edu
Houdart
E
E
Szopinski
K T
KT
Levrier
O
O
Guimaraens
L
L
Kühne
D
D
Solymosi
L
L
Bartholdy
N J
NJ
Rüfenacht
D A
DA
D000328:Adult; D000368:Aged; D001165:Arteriovenous Malformations / Q000000981:diagnostic imaging / Q000628:therapy*; D020785:Central Nervous System Vascular Malformations / Q000000981:diagnostic imaging / Q000628:therapy*; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009333:Neck / Q000098:blood supply; D010984:Platinum; D011859:Radiography; D012449:Safety
D010984:Platinum