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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease (Left Main)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No