TRAIL Analyzes MicroVention Terumo's LVIS and LVIS Jr Devices to Treat Intracranial Aneurysms
November 28, 2017—Results of the TRAIL study were published by Christina Iosif, MD, et al online in Journal of NeuroInterventional Surgery (JNIS).
The TRAIL study sought to evaluate the safety and efficacy of the LVIS and LVIS Jr low-profile visualized intraluminal support braided intracranial stents (MicroVention Terumo) for stent-assisted coil embolization of wide-necked intracranial aneurysms. The TRAIL study's Principal Investigators are Professor Charbel Mounayer, MD, of CHU Limoges in Limoges, France, and Michel Piotin, MD, of Fondation Rothschild in Paris, France.
The investigators concluded that the LVIS/LVIS Jr endovascular devices are safe and effective for the treatment of ruptured and unruptured intracranial aneurysms, with acceptable complication rates, very high immediate total occlusion rates, and stable angiographic results.
As summarized in JNIS, TRAIL is a prospective, multicenter, observational study of unruptured and ruptured intracranial aneurysms treated with the LVIS devices. Imaging and clinical data were independently analyzed respectively by a core lab and a clinical events committee. Primary endpoints were clinical safety, effectiveness, and angiographic stability of the results at 6 and 18 months.
Ten centers in France participated in the study that enrolled 102 patients and eventually analyzed 90 patients (42.2% men, 57.8% women), among which 27 (30%) had multiple aneurysms. Twenty-three (25.6%) were ruptured aneurysms, four of which (4.4%) were treated in the acute phase. One aneurysm was treated per patient; 92 LVIS and LVIS Jr devices were placed overall.
The investigators reported that the total aneurysm occlusion rate was 91% on immediate postprocedure angiograms, which remained unchanged at 6-month follow-up and was 92.4% at 18-month follow-up. One patient (1.1%) underwent retreatment between 6 and 18 months of follow-up. A modified Rankin score of 0 was documented for most cases immediately after the procedure (86.7%) and at 6-month (86.8%) and 18-month (83.3%) follow-up.
The overall permanent morbidity rate at 18 months was 5.6%, and the overall rate of events with sequelae related to the stent was 2.2%. The 18-month procedure-related mortality rate was 3.3%. No patient was deemed to require retreatment at 18-month follow-up, noted the investigators in JNIS.