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

NCT02800837 | Unknown

• 1 other identifier: ST2016-01
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 4

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.

Conditions

Coronary Artery Disease (Left Main)

Keywords

left main; stent; self-expandable; DES; Stentys

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Procedural Success

  48 hours post procedure (hospital discharge)

• TLF

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stentys: lead

Study Sites (4)

Ferraroto Hospital - Catania University

Catania, Italy

NOT YET RECRUITING

Clinica Mediterranea

Naples, Italy

NOT YET RECRUITING

St Gallen Kantonsspital

Sankt Gallen, Switzerland

RECRUITING

Bristol Heart Institute

Bristol, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 25639945 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: June 15, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: June 15, 2016

Record last verified: 2016-05

Locations

CH (1); GB (1); IT (2)