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Status unknownNCT02800837TRUNCUpdated Jun 15, 2016

Clinical Study to Evaluate the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

An observational study in Coronary Artery Disease (Left Main), sponsored by Stentys. Status unknown at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-15.

Sponsored by Stentys · Observational

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

Prospective, non-randomized, multi-center study assessing the long term safety and efficacy of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected left main coronary artery disease.

Read the detailed description

In the treatment of unprotected left main coronary artery (ULMCA) disease, previous mono-center studies have shown promising results with the previous generation of the self-expandable STENTYS stent (paclitaxel eluting stent, delivered via withdrawal of a sheath).

The TRUNC study aims at assessing at large scale the Xposition S in the treatment of ULMCA disease. The Xposition S is a sirolimus eluting stent, mounted on a balloon delivery system. The study aims at collecting clinical practice routine data from 200 patients.

02

Conditions studied

  • Coronary Artery Disease (Left Main)

Keywords

  • left main
  • stent
  • self-expandable
  • DES
  • Stentys
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 200 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Stentys is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with coronary artery stenosis (unprotected left main coronary artery), indicated for Percutaneous Coronary Intervention (PCI) and Xposition S stent treatment.

Eligibility criteria

Main Inclusion Criteria:

  • Subject ≥ 18 years old;
  • Presence of coronary artery stenosis in the unprotected Left Main (LM) Coronary Artery which is indicated for PCI and Xposition S stent treatment
  • Left Main Coronary Artery reference vessel diameter ranging from 2.5 mm to 6.0 mm;
  • The subject is able to provide voluntary informed consent, willing to comply with all study requirements and sign the written informed consent.

Main Exclusion Criteria:

  • Recent STEMI (\<1 month) ;
  • SYNTAX score ≥ 33 ;
  • Highly calcified lesions or excessive tortuosity at target lesion site;
  • Subject unable to comply with dual antiplatelet therapy as recommended per guidelines;
  • Planned cardiac surgery or valve intervention within the next 12 months.
  • Participation to other investigational drug or device studies that have not reached their primary endpoint.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Clinical Endpoint- Target Lesion Failure (TLF)

    TLF defined as cardiac death, MI not attributable to a non target vessel, or clinically driven target lesion revascularization

    Time frame: 12 months post-procedure

  2. Efficacy Endpoint - Angiographic Success

    Achievement of \<20% final residual stenosis at target lesion (visual estimation) with TIMI 3 flow in main branch

    Time frame: 12 months post-procedure

Secondary outcomes

  1. Procedural Success

    Angiographic success without occurence of death, target lesion related MI or target lesion revascularization prior to hospital discharge visit

    Time frame: 48 hours post procedure (hospital discharge)

  2. TLF

    TLF defined as cardiac death, Myocardial Infarction(MI) not attributable to a non target vessel, or clinically driven target lesion revascularization

    Time frame: 30 days post procedure

  3. Cardiac Death Rate

    Time frame: 30 days, 12 months and 24 months post procedure

  4. MI rate (not attributable to a non target vessel)

    Time frame: 30 days, 12 months and 24 months post procedure

  5. Clinically Driven Target Lesion Revascularization

    Time frame: 30 days, 12 months and 24 months post procedure

  6. Stroke Events Rate

    Time frame: 30 days, 12 and 24 months post procedure

  7. Stent Thrombosis Events Rate

    Time frame: 30-day, 12-month and 2 year post-procedure

  8. Index Procedure Duration

    Time frame: End of the index procedure

  9. Fluoroscopy Time, during Index Procedure

    Time frame: End of the index procedure

  10. Acute Stent Malappositon by IVUS (IVUS Substudy)

    Assessed in a subset of patients

    Time frame: End of the index procedure

  11. Minimal Lumen Area by IVUS (IVUS substudy)

    Assessed in a subset of patients

    Time frame: End of the index procedure

07

Study locations

1 of 4 sites recruiting
  • Ferraroto Hospital - Catania University
    Catania, Italy
    • Corrado Tamburino · Principal investigator
    Not yet recruiting
  • Clinica Mediterranea
    Naples, Italy
    • Carlo Briguori · Principal investigator
    Not yet recruiting
  • St Gallen Kantonsspital
    St Gallen, Switzerland
    • Daniel Weilenmann · Contact · +41 71 494 10 51
    • Daniel Weillenmann · Principal investigator
    Recruiting
  • Bristol Heart Institute
    Bristol, United Kingdom
    • Andreas Baumbach · Principal investigator
    Not yet recruiting
08

References and documents

Publications

  • Briguori C, Visconti G, Donahue M, Focaccio A, Mitomo S, Kawamoto H, Nakamura S. The STENTYS(R) paclitaxel-eluting stent in the treatment of unprotected distal left main. Catheter Cardiovasc Interv. 2015 Sep;86(3):E131-9. doi: 10.1002/ccd.25874. Epub 2015 Feb 25. PubMed 25639945 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02800837
Lead sponsor
Stentys
Responsible party
Sponsor
First posted
Jun 15, 2016
Start date
May 2016
Primary completion
Jun 2018 (estimated)
Completion
Jun 2019 (estimated)
Last update
Jun 15, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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