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

Abstract

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.

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Acknowledgements

This research could not have been conducted without the help of Denny Herberger at Medical Scientific Affairs B.Braun, Berlin for his logistic support to obtain ethics approvals.

Funding

This study was funded by B.Braun on a milestone basis per included patient and available follow-ups at 6 and 12 months. The study was designed conjointly by the coordinating investigator and the funding body. Data were analyzed by a third party statistician and interpretation of the data was conducted by the coordinating investigator (KA). The first draft of the paper was prepared by MS and MW.

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Correspondence to Martin Sigl.

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Conflict of interest

KA and RL have received lecturer honoraria and research grants from B.Braun to conduct this study. MW is a full-time employee in the Medical Scientific Affairs department of B.Braun Melsungen AG, Vascular Systems, Berlin/Germany. TZ received honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific Corp., Cook Medical, Gore and Associates, Medtronic, Philips-Spectranetics, TriReme, Veryan, Shockwave, Biotronik, QT Medical and consulted for Boston Scientific Corp., Cook Medical, Gore and Associates, Medtronic, Spectranetics, and B.Braun.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study. This study has obtained IRB approval from the Ethics Committee University Heidelberg/Mannheim and an informed consent was reviewed and authorized by this lead ethics committee and all other ethics committees that were responsible for the participating centers.

Consent for Publication

Consent for publication was obtained for every individual person’s data included in the study. There are no individual data of adult patients in any form published in this report.

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Sigl, M., Beschorner, U., Zeller, T. et al. Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study. Cardiovasc Intervent Radiol 42, 169–175 (2019). https://doi.org/10.1007/s00270-018-2095-9

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Keywords

  • Femoropopliteal lesions
  • Multiple stent segments
  • Target lesion revascularization
  • Patency