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

NCT01148329 | Completed

• 1 other identifier: S2057
• Study Type: observational
• Target: 1,010
• Locations: 11 countries
• Sites: 40

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.

Conditions

Coronary Heart Disease

Keywords

Coronary stenting; Drug-eluting stent; Post-market surveillance study; Promus Element stent

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure (TVF)

  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.

  One year

Secondary Outcomes (8)

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

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

• Death or MI rates

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

• TVR rates

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

• Cardiac death rates

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

• MI Rates

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

Study Arms (1)

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

Interventions

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.

Single arm observational study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• According to Instructions For Use

You may not qualify if:

• Contraindications according to Instructions for Use

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Pharmaceutical Research Associates: collaborator
• Medidata Solutions: collaborator

Study Sites (40)

Allgemeines Krankenhaus der Stadt Linz

Linz, A-4020, Austria

Location

Medizinische Universität Wien

Vienna, A-1090, Austria

Location

Klinikum Wels-Grieskirchen

Wels, 4600, Austria

Location

Virga Jesse Ziekenhuis

Hasselt, 3500, Belgium

Location

Centre Hôpital Universitaire Sart Tilman

Liège, B4000, Belgium

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Roskilde Sygehus

Roskilde, 4000, Denmark

Location

Centre Hospitalier Privé Saint Martin gds

Caen, 14000, France

Location

Le Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Polyclinique les Fleurs

Ollioules, 83192, France

Location

Clinique St. Martin

Pessac, 33608, France

Location

Clinique Saint-Hilaire Rouen

Rouen, 76000, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Klinikum Leverkusen

Leverkusen, North Rhine-Westphalia, 51375, Germany

Location

Zentralklinik Bad Berka GmbH

Bad Berka, 99437, Germany

Location

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Klinikum Darmstadt

Darmstadt, 64283, Germany

Location

Med. Hochschule Hannover

Hanover, 30625, Germany

Location

Schwarzwald Baar Klinikum Villingen-Schwenningen

Villingen-Schwenningen, 78050, Germany

Location

Dept. of Internal Medicine and Cardiological Center

Szeged, 6720, Hungary

Location

Beaumont Hospital

Dublin, D9, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

St. James's Hospital

Dublin, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24128, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Clinica Mediterranea

Napoli, 80121, Italy

Location

IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 RW, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, 3300 AK, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, 6532 SZ, Netherlands

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, 8916, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Papworth Hospital

Cambridge, CB23 3RE, United Kingdom

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

St. Thomas Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital London

London, SE5 9RS, United Kingdom

Location

Freeman, Newcastle-Upon-Tyne

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

• Thomas MR, Birkemeyer R, Schwimmbeck P, Legrand V, Moreno R, Briguori C, Werner N, Bramucci E, Ungi I, Richardt G, Underwood PL, Dawkins KD. One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study. EuroIntervention. 2015 Mar;10(11):1267-71. doi: 10.4244/EIJY15M01_07.

  PMID: 25631367 RESULT

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Raul Moreno, MD PhD

  Hospital La Paz, Spain

  PRINCIPAL INVESTIGATOR

• Peter Maurer, PhD

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); DK (2); AU (3); DE (8); GB (5); NL (3); BE (2); HU (1); IE (4); FR (6); IT (4)