Clinical Trial of the New Stent Retriever Tron FX for both Proximal and Distal Intracranial Large Vessel Occlusions.
BACKGROUND
In all of randomized controlled trials of mechanical thrombectomy, the target vessels were proximal. Herein we report a clinical trial of the Tron FX stent retriever, including the smallest size of 2/15 mm for distal intracranial large vessel occlusion (LVO).


OBJECTIVE
Eligible patients presented within 8 h of onset with proximal or distal LVOs, and the Tron FX 4/20 mm or 2/15 mm were used as the first-line device.


METHODS
The primary endpoints were rate of modified Thrombolysis in Cerebral Infarction (mTICI) grade 2a-3 immediately after using Tron FX only, and mortality rate 90 d. We compared the outcomes between sizes 4/20 and 2/15 mm.


RESULTS
The clinical trial was conducted in 50 cases, of which 44% presented with distal LVO and 15 cases were treated using only Tron FX 2/15 mm. The overall rate of mTICI grade 2a-3 was 80.0% (75.8% with Tron FX 4/20 mm, and 86.7% with 2/15 mm), and a 90-day modified Rankin Scale ≤ 2 or improvement of National Institute of Health Stroke Scale after thrombectomy ≥ 10 was achieved in 66.7% of cases (61.3% with Tron FX 4/20 mm, and 80.0% with 2/15 mm). The overall 90-day mortality rate was 8.0%, and symptomatic intracranial hemorrhage within 24 h occurred in 2.0% of cases.


CONCLUSION
In this clinical trial using the Tron FX, which included the size of 2/15 mm for distal LVO, its efficacy was similar and its safety was superior compared with previous studies.
['Imamura|Hirotoshi|H|', 'Sakai|Nobuyuki|N|', 'Yamagami|Hiroshi|H|', 'Satow|Tetsu|T|', 'Matsumoto|Yasushi|Y|', 'Imai|Keisuke|K|', 'Ota|Shinzo|S|', 'Horie|Nobutaka|N|', 'Kondo|Rei|R|', 'Enomoto|Yukiko|Y|', 'Yoshimura|Shinichi|S|', 'Hirohata|Masaru|M|', 'Shibata|Masunari|M|', 'Matsumaru|Yuji|Y|', 'Ohara|Nobuyuki|N|', 'Sakai|Chiaki|C|', '|||']
D000328:Adult D000368:Aged D000369:Aged, 80 and over D002560:Cerebrovascular Circulation D004185:Disability Evaluation D057510:Endovascular Procedures D005260:Female D006801:Humans D020300:Intracranial Hemorrhages D000083242:Ischemic Stroke D007564:Japan D008297:Male D008875:Middle Aged D011474:Prosthesis Design D020127:Recovery of Function D015607:Stents D015912:Thrombolytic Therapy D013997:Time Factors D016896:Treatment Outcome
Clinical trial Stent retriever Mechanical thrombectomy Intracranial distal vessel occlusion