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

June 10, 2016 updated by: Stentys

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy
        • Not yet recruiting
        • Ferraroto Hospital - Catania University
        • Principal Investigator:
          • Corrado Tamburino
      • Naples, Italy
        • Not yet recruiting
        • Clinica Mediterranea
        • Principal Investigator:
          • Carlo Briguori
  • Switzerland
      • St Gallen, Switzerland
        • Recruiting
        • St Gallen Kantonsspital
        • Contact:
          • Daniel Weilenmann
          • Phone Number: +41 71 494 10 51
        • Principal Investigator:
          • Daniel Weillenmann
  • United Kingdom
      • Bristol, United Kingdom
        • Not yet recruiting
        • Bristol Heart Institute
        • Principal Investigator:
          • Andreas Baumbach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Endpoint- Target Lesion Failure (TLF)
Time Frame: 12 months post-procedure
TLF defined as cardiac death, MI not attributable to a non target vessel, or clinically driven target lesion revascularization
12 months post-procedure
Efficacy Endpoint - Angiographic Success
Time Frame: 12 months post-procedure
Achievement of <20% final residual stenosis at target lesion (visual estimation) with TIMI 3 flow in main branch
12 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural Success
Time Frame: 48 hours post procedure (hospital discharge)
Angiographic success without occurence of death, target lesion related MI or target lesion revascularization prior to hospital discharge visit
48 hours post procedure (hospital discharge)
TLF
Time Frame: 30 days post procedure
TLF defined as cardiac death, Myocardial Infarction(MI) not attributable to a non target vessel, or clinically driven target lesion revascularization
30 days post procedure
Cardiac Death Rate
Time Frame: 30 days, 12 months and 24 months post procedure
30 days, 12 months and 24 months post procedure
MI rate (not attributable to a non target vessel)
Time Frame: 30 days, 12 months and 24 months post procedure
30 days, 12 months and 24 months post procedure
Clinically Driven Target Lesion Revascularization
Time Frame: 30 days, 12 months and 24 months post procedure
30 days, 12 months and 24 months post procedure
Stroke Events Rate
Time Frame: 30 days, 12 and 24 months post procedure
30 days, 12 and 24 months post procedure
Stent Thrombosis Events Rate
Time Frame: 30-day, 12-month and 2 year post-procedure
30-day, 12-month and 2 year post-procedure
Index Procedure Duration
Time Frame: End of the index procedure
End of the index procedure
Fluoroscopy Time, during Index Procedure
Time Frame: End of the index procedure
End of the index procedure
Acute Stent Malappositon by IVUS (IVUS Substudy)
Time Frame: End of the index procedure
Assessed in a subset of patients
End of the index procedure
Minimal Lumen Area by IVUS (IVUS substudy)
Time Frame: End of the index procedure
Assessed in a subset of patients
End of the index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stentys

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ST2016-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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