Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study.
INTRODUCTION
The purpose of this observational study is to report the 12-month clinical outcomes with the novel Multiple Stent Delivery System (MSDS) to treat complex femoropopliteal lesions. Previously, we reported the 6-month clinical outcomes of the all-comers LOCOMOTIVE study, which demonstrated the safety and efficacy of the MSDS with a favorable target lesion revascularization (TLR) rate of 5.3% and a 90.7% patency rate at 6 months in claudicants and critical limb ischemia patients. The 12-month outcomes of LOCOMOTIVE registry are presented in this report. ClinicalTrials.gov Identifier: NCT02531230.


METHODS
The LOCOMOTIVE study (Multi-LOC for flOw liMiting Outcomes after POBA and/or DCB Treatment in the infrainguinal position with the objecIVE to implant multiple stent segments) investigates the efficacy and safety of the MSDS approach in an all-comers population. Clinical follow-ups at 6 and 12 months are scheduled to assess TLR, ABI, and vessel patency based on sonographic imaging.


RESULTS
At 12 months, the primary unassisted patency was 85.7% and all-cause TLR rate was 9.3% in the overall cohort. Between baseline and 12 months, the target leg ABI increased from 0.62 ± 0.24 to 0.91 ± 0.38 (p < 0.001) and the mean Rutherford class improved from 3.5 to 1.9 (p < 0.001).


CONCLUSIONS
Over a 12-month post-procedural period, MSDS for focal provisional stenting of complex femoropopliteal lesions demonstrated a promising primary patency and freedom from TLR after 12 months. In addition, significant improvements were observed in symptom classification and hemodynamics.
['Sigl|Martin|M|http://orcid.org/0000-0001-6162-6304', 'Beschorner|Ulrich|U|', 'Zeller|Thomas|T|', 'Waliszewski|Matthias|M|', 'Langhoff|Ralf|R|', 'Tautenhahn|Jörg|J|', 'Amendt|Klaus|K|']
D000368:Aged D005260:Female D005263:Femoral Artery D005500:Follow-Up Studies D006801:Humans D008297:Male D058729:Peripheral Arterial Disease D011150:Popliteal Artery D012042:Registries D015607:Stents D013995:Time D016896:Treatment Outcome D014463:Ultrasonography D014654:Vascular Patency
Femoropopliteal lesions Target lesion revascularization Patency Multiple stent segments