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OpenTrials
Completed

NCT Number: NCT02150876

SWiss Evaluation of Bioabsorbable Polymer-coated Everolimus-eluting Coronary sTent

Bioresorbable polymer drug eluting stents (DES) are an indisputable improvement over first-generation DES with promising results on long-term adverse events. But the thicker polymer and/or strut may hinder its deliverability. Complex procedures challenge stent deliverability and stent delivery failure impacts clinical prognosis.

This registry aimed to assess the immediate performance of the third-generation Synergy everolimus-eluting stent (sEES) and its 12-month clinical follow-up in an all-comer population.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Freiburg

Fribourg, Canton of Fribourg, 1700, Switzerland

About this study

All consecutive patients treated with the SYNERGY stent at our institutions were prospectively included in the SWEET registry. Baseline and procedural characteristics were collected at index procedure. Clinical follow-up was performed at 1 month and 1 year by clinic visit or follow-up call. The study end point was a composite of cardiac death (CD), myocardial infarction (MI) and target lesion revascularization (TLR) at 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.Patient treated by everolimus-eluting SYNERGY® stent

Exclusion criteria

  • Patient or legal guardian won't give consent to use collected data

Treatment and study plan

Primary outcomes

  1. MACE

    Time frame: at 12 month follow up

    12-month device-oriented MACE (dMACE) as defined by ARC (cardiac death, MI and TLR).

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

SWiss Evaluation of Bioabsorbable Polymer-coated Everolimus-eluting Coronary sTent The SWEET Registry

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 30, 2014
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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