PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study (PE-Prove)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pharmaceutical Research Associates, Inc.
Medidata Solutions
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01148329
First received: June 21, 2010
Last updated: August 9, 2013
Last verified: August 2013

June 21, 2010
August 9, 2013
June 2010
May 2012   (final data collection date for primary outcome measure)
Target Vessel Failure (TVF) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
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.
Target Vessel Failure [ Time Frame: One year ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01148329 on ClinicalTrials.gov Archive Site
  • Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR) [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR).
  • Death or MI rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related cardiac death or MI rates
  • TVR rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: No ]
    Overall and PROMUS™ Element™ stent-related TVR rates.
  • Cardiac death rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related cardiac death rates.
  • MI Rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related MI rates.
  • All death rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    All death rates
  • Non-cardiac death rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Non-cardiac death rates
  • All death or MI rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    All death and MI rates
  • MACE rates (cardiac death, MI, TVR) [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR).
  • Death or MI rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related cardiac death or MI rates
  • TVR rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: No ]
    Overall and PROMUS™ Element™ stent-related TVR rates.
  • Cardiac death rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related cardiac death rates.
  • MI Rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Overall and PROMUS™ Element™ stent-related MI rates.
  • All death rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    All death rates
  • Non-cardiac death rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    Non-cardiac death rates
  • All death or MI rates [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years ] [ Designated as safety issue: Yes ]
    All death and MI rates
Not Provided
Not Provided
 
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All patients who are candidates for Coronary artery stenting, signed the Informed Consent Form and are eligible to receive a PROMUS™ Element™ stent will be evaluated for enrollment in this study.

Coronary Heart Disease
Device: Coronary stenting
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.
Single arm observational study
To evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice
Intervention: Device: Coronary stenting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1010
March 2016
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • According to Instructions For Use

Exclusion Criteria:

  • Contraindications according to Instructions for Use
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Austria,   Ireland,   Belgium,   Italy,   France,   Hungary,   United Kingdom,   Spain,   Germany,   Denmark,   Sweden
 
NCT01148329
S2057
No
Boston Scientific Corporation
Boston Scientific Corporation
  • Pharmaceutical Research Associates, Inc.
  • Medidata Solutions
Principal Investigator: Martyn R Thomas, MD PhD Guy's and St. Thomas NHS Foundation Trust, UK
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
Boston Scientific Corporation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP