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

Stentys

Status: Unknown

Conditions: Coronary Artery Disease (Left Main)

Study type: Observational

Funder types: Industry

Identifiers

NCT02800837

ST2016-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.