Coronary Heart DiseasePE-ProveNCT01148329
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
An observational study of Coronary Heart Disease, run by Boston Scientific Corporation at 40 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Coronary stenting
- Type of treatment
- Medical device
- How many people
- 1,010 participants
- Where
- 40 sitesin 11 countries
- Study dates
- Jun 2010to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- According to Instructions For Use
Who cannot join
- Contraindications according to Instructions for Use
Trial locations and contacts
40 sites in 11 countries.
40 sites in 11 countries
Germany8 sites
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Bad Segeberg, 23795
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53105
Klinikum Darmstadt
Darmstadt, 64283
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Med. Hochschule Hannover
Hanover, 30625
Klinikum Leverkusen
Leverkusen, North Rhine-Westphalia, 51375
Schwarzwald Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, 78050
France6 sites
Centre Hospitalier Privé Saint Martin gds
Caen, 14000
Le Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
Polyclinique les Fleurs
Ollioules, 83192
Clinique St. Martin
Pessac, 33608
Clinique Saint-Hilaire Rouen
Rouen, 76000
Clinique Pasteur
Toulouse, 31076
United Kingdom5 sites
Papworth Hospital
Cambridge, CB23 3RE
University Hospital of Wales
Cardiff, CF14 4XW
St. Thomas Hospital
London, SE1 7EH
King's College Hospital London
London, SE5 9RS
Freeman, Newcastle-Upon-Tyne
Newcastle upon Tyne, NE7 7DN
Ireland4 sites
Beaumont Hospital
Dublin, D9
Mater Misericordiae University Hospital
Dublin
St. James's Hospital
Dublin
Galway University Hospital
Galway
Italy4 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24128
Centro Cardiologico Monzino
Milan, 20138
Clinica Mediterranea
Naples, 80121
IRCCS Policlinico S. Matteo
Pavia, 27100
Austria3 sites
Allgemeines Krankenhaus der Stadt Linz
Linz, A-4020
Medizinische Universität Wien
Vienna, A-1090
Klinikum Wels-Grieskirchen
Wels, 4600
Netherlands3 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5211 RW
Albert Schweitzer Ziekenhuis
Dordrecht, 3300 AK
Canisius Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ
Belgium2 sites
Virga Jesse Ziekenhuis
Hasselt, 3500
Centre Hôpital Universitaire Sart Tilman
Liège, B4000
Denmark2 sites
Odense University Hospital
Odense, 5000
Roskilde Sygehus
Roskilde, 4000
Spain2 sites
Hospital Universitari Germans Trias i Pujol
Barcelona, 8916
Hospital Universitario La Paz
Madrid, 28046
Hungary1 site
Dept. of Internal Medicine and Cardiological Center
Szeged, 6720
About this study
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
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
- Being tested
- Coronary stenting
- Keywords
- Coronary stenting, Drug-eluting stent, Post-market surveillance study, Promus Element stent
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary stentingDevice
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 | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Coronary stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (8)
Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR)
Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR).
Measured: 30 days, 6 months, 12 months and then annually through 5 years
Death or MI rates
Overall and PROMUS™ Element™ stent-related cardiac death or MI rates
Measured: 30 days, 6 months, 12 months and then annually through 5 years
TVR rates
Overall and PROMUS™ Element™ stent-related TVR rates.
Measured: 30 days, 6 months, 12 months and then annually through 5 years
Cardiac death rates
Overall and PROMUS™ Element™ stent-related cardiac death rates.
Measured: 30 days, 6 months, 12 months and then annually through 5 years
MI Rates
Overall and PROMUS™ Element™ stent-related MI rates.
Measured: 30 days, 6 months, 12 months and then annually through 5 years
All death rates
All death rates
Measured: 30 days, 6 months, 12 months and then annually through 5 years
Non-cardiac death rates
Non-cardiac death rates
Measured: 30 days, 6 months, 12 months and then annually through 5 years
All death or MI rates
All death and MI rates
Measured: 30 days, 6 months, 12 months and then annually through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates, Medidata Solutions
- Responsible party
- Sponsor
- Investigators
- Raul Moreno, MD PhD, Principal investigator, Hospital La Paz, SpainPeter Maurer, PhD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148329
- Sponsor's protocol ID
- S2057
- Acronym
- PE-Prove
- Status last verified
- Feb 2017
- First submitted
- 21 Jun 2010
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data are presented at the 2013 EuroPCR congress.
Publications
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.
PubMed 25631367
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01148329
- Acronym / sponsor ID
- PE-Prove / S2057
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary stenting, Drug-eluting stent, Post-market surveillance study, Promus Element stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates, Medidata Solutions
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm observational study | – | Device: Coronary stentingTo evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- According to Instructions For Use
Key exclusion criteria (1 listed)
- Contraindications according to Instructions for Use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary stentingThe 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. | Device | Single arm observational study |
Primary outcome
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.
8 secondary outcomes
Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR)
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
Death or MI rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
TVR rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
Cardiac death rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
MI Rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
All death rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
Non-cardiac death rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
All death or MI rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Results publication: PubMed 25631367Thomas 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.
- Individual participant dataSharing planned: No. Data are presented at the 2013 EuroPCR congress.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul Moreno, MD PhD principal investigator
Hospital La Paz, Spain
Peter Maurer, PhD study director
Boston Scientific Corporation
40 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Boston Scientific Corporation at 40 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Germany, France, United Kingdom, Ireland, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure (TVF) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01148329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.