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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800837
Recruitment Status : Unknown
Verified May 2016 by Stentys.
Recruitment status was:  Recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Stentys

Brief 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.

Condition or disease
Coronary Artery Disease (Left Main)

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multicenter Prospective Clinical Study of the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  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) [ Time Frame: End of the index procedure ]
    Assessed in a subset of patients

  11. Minimal Lumen Area by IVUS (IVUS substudy) [ Time Frame: End of the index procedure ]
    Assessed in a subset of patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800837


Locations
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Italy
Ferraroto Hospital - Catania University Not yet recruiting
Catania, Italy
Principal Investigator: Corrado Tamburino         
Clinica Mediterranea Not yet recruiting
Naples, Italy
Principal Investigator: Carlo Briguori         
Switzerland
St Gallen Kantonsspital Recruiting
St Gallen, Switzerland
Contact: Daniel Weilenmann    +41 71 494 10 51      
Principal Investigator: Daniel Weillenmann         
United Kingdom
Bristol Heart Institute Not yet recruiting
Bristol, United Kingdom
Principal Investigator: Andreas Baumbach         
Sponsors and Collaborators
Stentys
Publications:
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Responsible Party: Stentys
ClinicalTrials.gov Identifier: NCT02800837    
Other Study ID Numbers: ST2016-01
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: May 2016
Keywords provided by Stentys:
left main
stent
self-expandable
DES
Stentys
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases