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Coronary Artery Disease (Left Main)TRUNCNCT02800837

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

An observational study of Coronary Artery Disease (Left Main), run by Stentys at 4 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease (Left Main)
How many people
200 participants
Where
4 sitesin 3 countries
Study dates
May 2016to Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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.

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Italy2 sites, 2 recruiting

  • Ferraroto Hospital - Catania University

    Catania

    Corrado Tamburino

    Not yet recruiting

  • Clinica Mediterranea

    Naples

    Carlo Briguori

    Not yet recruiting

Other trials in Italy

Switzerland1 site, 1 recruiting

  • St Gallen Kantonsspital

    Sankt Gallen

    Daniel Weilenmann, +41 71 494 10 51

    Daniel Weillenmann

    Recruiting

Other trials in Switzerland

United Kingdom1 site, 1 recruiting

  • Bristol Heart Institute

    Bristol

    Andreas Baumbach

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: Multicenter Prospective Clinical Study of the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

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.

Keywords
left main, stent, self-expandable, DES, Stentys
Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 12 months post-procedure

Secondary outcomes (11)

  1. Procedural Success

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

    Measured: 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

    Measured: 30 days post procedure

  3. Cardiac Death Rate

    Measured: 30 days, 12 months and 24 months post procedure

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

    Measured: 30 days, 12 months and 24 months post procedure

  5. Clinically Driven Target Lesion Revascularization

    Measured: 30 days, 12 months and 24 months post procedure

  6. Stroke Events Rate

    Measured: 30 days, 12 and 24 months post procedure

  7. Stent Thrombosis Events Rate

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

  8. Index Procedure Duration

    Measured: End of the index procedure

  9. Fluoroscopy Time, during Index Procedure

    Measured: End of the index procedure

  10. Acute Stent Malappositon by IVUS (IVUS Substudy)

    Assessed in a subset of patients

    Measured: End of the index procedure

  11. Minimal Lumen Area by IVUS (IVUS substudy)

    Assessed in a subset of patients

    Measured: End of the index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionJun 2018 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02800837
Sponsor's protocol ID
ST2016-01
Acronym
TRUNC
Status last verified
May 2016
First submitted
9 May 2016
Last updated
15 Jun 2016
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease (Left Main), run by Stentys at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Endpoint- Target Lesion Failure (TLF) (time frame: 12 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02800837, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.

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