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Completed

NCT Number: NCT01148329

PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study

The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Allgemeines Krankenhaus der Stadt Linz, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • According to Instructions For Use

Exclusion criteria

  • Contraindications according to Instructions for Use

Treatment and study plan

coronary stenting

Device

The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm.

Primary outcomes

  1. Target Vessel Failure (TVF)

    Time frame: One year

    Overall and PROMUS™ Element™ stent related TVF rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation.

Secondary outcomes

  1. Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR)

    Time frame: 30 days, 6 months, 12 months and then annually through 5 years

    Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR).

  2. Death or MI rates

    Time frame: 30 days, 6 months, 12 months and then annually through 5 years

    Overall and PROMUS™ Element™ stent-related cardiac death or MI rates

  3. TVR rates

    Time frame: 30 days, 6 months, 12 months and then annually through 5 years

    Overall and PROMUS™ Element™ stent-related TVR rates.

  4. Cardiac death rates

    Time frame: 30 days, 6 months, 12 months and then annually through 5 years

    Overall and PROMUS™ Element™ stent-related cardiac death rates.

  5. MI Rates

    Time frame: 30 days, 6 months, 12 months and then annually through 5 years

    Overall and PROMUS™ Element™ stent-related MI rates.

  6. All death rates

    Time frame: 30 days, 6 months, 12 months and then annually through 5 years

    All death rates

  7. Non-cardiac death rates

    Time frame: 30 days, 6 months, 12 months and then annually through 5 years

    Non-cardiac death rates

  8. All death or MI rates

    Time frame: 30 days, 6 months, 12 months and then annually through 5 years

    All death and MI rates

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • Medidata Solutions
  • Pharmaceutical Research Associates

Registry information

Official study title

PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

Acronym: PE-Prove

Important dates

Study start
2010
Primary completion
2012
Study completion
2016
First posted
Jun 22, 2010
Registry last updated
Feb 2, 2017

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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