Xposition S in Left Main

The results of the TRUNC Study, Xposition S in Left Main stenting, were released during TCT in San Diego, during a Moderated Poster session presented by Professor Corrado Tamburino (Ferrarotto Hospital, University of Catania, Catania, Italy) entitled “Prospective Evaluation of Drug Eluting Self-Apposing Stent for the Treatment of Unprotected Left Main Coronary Artery Disease: 1-Year Results of the TRUNC Study”

The results highlight the benefits of the Self-Apposing stent technology in achieving comparable outcomes to contemporary DES studies whilst avoiding the need for routine Proximal Optimisation (POT) or Final Kissing Balloon (FKB) Techniques 



  • Design and Enrolment

     
    OBJECTIVE
    • To assess long-term safety and efficacy of Xposition S stent in the treatment of unprotected left main coronary artery disease.

     

    DESIGN
    • The TRUNC trial is a prospective, non-randomized, multi-center study.
    • Planned 200 patients (IVUS analysis subgroup 50 patients: analysis of malapposition post procedure).

     

    MAIN INCLUSION CRITERIA
    • Coronary artery stenosis in the unprotected LM coronary artery indicated for PCI and Xposition S stent treatment as per operator assessment
    • LM reference vessel diameter ranging from 2.5 mm to 6.0 mm

     

    MAIN EXCLUSION CRITERIA
    • Recent STEMI (<1month)
    • SYNTAX score ≥33

     

    ENDPOINTS
    • Primary clinical endpoint: Target Lesion Failure (TLF) at 12 months post-procedure (defined as cardiac death, Myocardial Infarction (MI) not attributed to a non-target vessel, or clinical-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods).
    • Primary efficacy endpoint: Angiographic success defined as placement of the stent as intended at the target lesion with achievement of <20% final residual stenosis of the target lesion, with TIMI 3 flow in main branch.

     

    STUDY ORGANIZATION
    • Steering Committee / Coordinating investigators: C. Tamburino, C. Briguori, A. Baumbach
    • Clinical Event Committee: S. Hoseyni, F. Sanguineti, P. Menasche
    • Angiography/IVUS Core Laboratory: CERC (Massy, FR)
    • Independent Monitoring: CERC (Massy, FR)     
  • Patient Demographics - n=205, SYNTAX score=20.8

     
  • Lesion Characteristics - 92.7% involvement of Distal Left Main

     
  • Treatment Data - 56% POT, 27% FKB

     
  • Procedural Outcomes - 97% Angiographic Success, 98% Complete Apposition

     
  • 12 Month Outcomes - 8.3% TLF driven by 5.4% cd-TLR

     

  • TLR rate was driven by Side Branch Stenosis

     

    Location of lesions causing clinically driven Target Lesion Restenosis (cd-TLR)

  • Resources

     

    Resources

    Download the Poster from TCT 2018

    Download File

    Resources

    Download a summary of the TRUNC data

    Download File

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Page ID 3198   |   Last edited 2018/10/17