Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study

Journal Article · Fri Feb 15 04:00:00 EST 2019 · Cardiovascular and Interventional Radiology

DOI:https://doi.org/10.1007/S00270-018-2095-9· OSTI ID:22953155

Sigl, Martin ^[1]; Beschorner, Ulrich; Zeller, Thomas ^[2]; Waliszewski, Matthias ^[3]; Langhoff, Ralf ^[4]; Tautenhahn, Jörg ^[5]; Amendt, Klaus ^[6]

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1. Universitätsmedizin Mannheim, First Department of Medicine (Germany)
2. Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH (Germany)
3. B.Braun Melsungen AG, Medical Scientific Affairs (Germany)
4. Sankt-Gertrauden-Krankenhaus, Angiologie (Germany)
5. Klinikum Magdeburg, Klinik für Gefäßchirurgie (Germany)
6. Diakonissenkrankenhaus Mannheim, Klinik für Angiologie, Kardiologie (Germany)

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.

• OSTI ID: 22953155
• Journal Information: Cardiovascular and Interventional Radiology, Journal Name: Cardiovascular and Interventional Radiology Journal Issue: 2 Vol. 42; ISSN 0174-1551; ISSN CAIRDG
• Country of Publication: United States
• Language: English

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