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: November 21, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 21, 2010

Last Updated Date

November 21, 2012

Start Date ^ICMJE

June 2010

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Target Vessel Failure [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01148329 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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.

Condition ^ICMJE

Coronary Heart Disease

Intervention ^ICMJE

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.

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

1010

Estimated Completion Date

March 2016

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

According to Instructions For Use

Exclusion Criteria:

Contraindications according to Instructions for Use

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Belgium, Denmark, France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01148329

Other Study ID Numbers ^ICMJE

S2057

Has Data Monitoring Committee

Responsible Party

Boston Scientific Corporation

Study Sponsor ^ICMJE

Boston Scientific Corporation

Collaborators ^ICMJE

Pharmaceutical Research Associates, Inc.
Medidata Solutions

Investigators ^ICMJE

Principal Investigator:	Martyn R Thomas, MD PhD	Guy's and St. Thomas NHS Foundation Trust, UK
Study Director:	Monika Hanisch, PhD	Boston Scientific Corporation

Information Provided By

Boston Scientific Corporation

Verification Date

November 2012

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

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