Clinical trial NCT02800837: Clinical Study to Evaluate the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease
Official title: Multicenter Prospective Clinical Study of the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease (Left Main)
Keywords: left main
stent
self-expandable
DES
Stentys
Lead sponsor: Stentys
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Clinical Endpoint- Target Lesion Failure (TLF)
timeFrame: 12 months post-procedure
measure: Efficacy Endpoint - Angiographic Success
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Procedural Success
timeFrame: 48 hours post procedure (hospital discharge)
measure: TLF
timeFrame: 30 days post procedure
measure: Cardiac Death Rate
timeFrame: 30 days, 12 months and 24 months post procedure
measure: MI rate (not attributable to a non target vessel)
timeFrame: 30 days, 12 months and 24 months post procedure
measure: Clinically Driven Target Lesion Revascularization
timeFrame: 30 days, 12 months and 24 months post procedure
measure: Stroke Events Rate
timeFrame: 30 days, 12 and 24 months post procedure
measure: Stent Thrombosis Events Rate
timeFrame: 30-day, 12-month and 2 year post-procedure
measure: Index Procedure Duration
timeFrame: End of the index procedure
measure: Fluoroscopy Time, during Index Procedure
timeFrame: End of the index procedure
measure: Acute Stent Malappositon by IVUS (IVUS Substudy)
timeFrame: End of the index procedure
measure: Minimal Lumen Area by IVUS (IVUS substudy)
timeFrame: End of the index procedure
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Ferraroto Hospital - Catania University
city: Naples
country: Italy
facility: Clinica Mediterranea
city: St Gallen
country: Switzerland
facility: St Gallen Kantonsspital
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
Study officials:
References:
citation: 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.