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
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Device: Coronary stenting

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 1010
Study Start Date: June 2010
Estimated Study Completion Date: March 2016
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • According to Instructions For Use

Exclusion Criteria:

  • Contraindications according to Instructions for Use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148329

  Hide Study Locations
Locations
Austria
llgemeines Krankenhaus der Stadt Linz
Linz, Austria, A-4020
Allgemeines Krankenhaus AKH
Vienna, Austria, A-1090
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
Belgium
Virga Jesse Ziekenhuis
Hasselt, Belgium, 3500
Centre Hôpital Universitaire Sart Tilman
Liege, Belgium, B4000
Denmark
Odense University Hospital
Odense, Denmark, 5000
Roskilde University Hospital
Roskilde, Denmark, 4000
France
CHP St. Martin
Caen, France, 14000
Le Centre Chirurgical Marie Lannelongue
Le Plessis Robinson, France, 92350
Polyclinique les Fleurs
Ollioules, France, 83192
Clinique St. Martin
Pessac, France, 33608
Clinique Saint-Hilaire Rouen
Rouen, France, 76000
Clinique Pasteur
Toulouse, France, 31076
Germany
Universitätsklinikum Bonn
Bonn, NRW, Germany, 53105
Universitätsklinikum Düsseldorf
Düsseldorf, NRW, Germany, 40225
Klinikum Leverkusen
Leverkusen, NRW, Germany, 51375
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
Klinikum Darmstadt
Darmstadt, Germany, 64283
Med. Hochschule Hannover
Hannover, Germany, 30625
Schwarzwald Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany, 78050
Hungary
Dept. of Internal Medicine and Cardiological Center
Szeged, Hungary, 6720
Ireland
St. James's Hospital
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland, D9
Mater Misericordiae University Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Centro Cardiologico Monzino
Milano, Italy, 20138
Clinica Mediterranea
Napoli, Italy, 80121
IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5211 RW
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands, 3300 AK
CWZ
Nijmegen, Netherlands, 6532 SZ
Spain
H. German Trias I Pujol
Barcelona, Spain, 8916
Hospital La Paz
Madrid, Spain, 28046
Sweden
University Hospital of Lund
Lund, Sweden, 211 85
United Kingdom
Papworth Hospital
Cambridge, United Kingdom, CB23 3RE
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Guys and St. Thomas NHS Foundation Trust
London, United Kingdom, SE1 7EH
King's College Hospital London
London, United Kingdom, SE5 9RS
Freeman, Newcastle-Upon-Tyne
Newcastle-Upon-Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Boston Scientific Corporation
Pharmaceutical Research Associates, Inc.
Medidata Solutions
Investigators
Principal Investigator: Martyn R Thomas, MD PhD Guy's and St. Thomas NHS Foundation Trust, UK
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01148329     History of Changes
Other Study ID Numbers: S2057
Study First Received: June 21, 2010
Last Updated: August 9, 2013
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Denmark: Danish Dataprotection Agency
France: Institutional Ethical Committee
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Ireland: Medical Ethics Research Committee
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Poland: Ethics Committee
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Boston Scientific Corporation:
Coronary stenting
Drug-eluting stent
Post-market surveillance study
Promus Element stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 23, 2014