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

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: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months post-procedure
Efficacy Endpoint - Angiographic Success	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

Outcome Measure	Measure Description	Time Frame
Procedural Success	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	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		30 days, 12 months and 24 months post procedure
MI rate (not attributable to a non target vessel)		30 days, 12 months and 24 months post procedure
Clinically Driven Target Lesion Revascularization		30 days, 12 months and 24 months post procedure
Stroke Events Rate		30 days, 12 and 24 months post procedure
Stent Thrombosis Events Rate		30-day, 12-month and 2 year post-procedure
Index Procedure Duration		End of the index procedure
Fluoroscopy Time, during Index Procedure		End of the index procedure
Acute Stent Malappositon by IVUS (IVUS Substudy)	Assessed in a subset of patients	End of the index procedure
Minimal Lumen Area by IVUS (IVUS substudy)	Assessed in a subset of patients	End of the index procedure

Collaborators and Investigators

• Sponsor: Stentys

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Estimate): June 15, 2016
• Last Update Submitted That Met QC Criteria: June 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: stent; DES; self-expandable; left main; Stentys
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: ST2016-01