De Novo and Re-stenosed Coronary Artery LesionsENERGYNCT01056120
Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
An observational study of De Novo and Re-stenosed Coronary Artery Lesions, run by Biotronik AG at 50 sites in 10 countries.
Trial summary
To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- De Novo and Re-stenosed Coronary Artery Lesions
- What is being tested?
- Pro Kinetic Energy bare metal stent
- Type of treatment
- Medical device
- How many people
- 1,026 participants
- Where
- 50 sitesin 10 countries
- Study dates
- Mar 2010to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Patient signed informed consent for data release
- Patient eligible for percutaneous coronary intervention (PCI)
- De novo and re-stenosed coronary artery lesions
- Patient is geographically stable and willing to participate at all follow up assessments
- Patient is > 18 years of age
Who cannot join
- Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel
- Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI
- Patient presents with ISR (in-stent restenosis)
Trial locations and contacts
50 sites in 10 countries.
50 sites in 10 countries
Germany17 sites
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen
Charité-Universitätsm. Berlin Campus Charité-Mitte
Berlin
Vivantes Humboldt Klinikum
Berlin
Universitätsklinikum Bonn
Bonn
Klinikum Dortmund GmbH
Dortmund
Städ. Klinikum Dresden- Friedrichstadt
Dresden
Westdeutsches Herzzentrum Essen
Essen, North Rhine-Westphalia, 45122
Alfried Krupp Klinikum Essen
Essen
Vinzenz Krankenhaus
Essen
Asklepios Klinikum St. Georg
Hamburg
St. Marien Hospital
Lünen
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück
Universitätsklinikum Regensburg
Regensburg
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer
Elbe Klinikum Stade GmbH
Stade
SRH Zentralklinikum Suhl
Suhl
Marien-Hospital Witten GmbH
Witten
France8 sites
Clinique Axium
Aix-en-Provence
Clinique Rhone Durance
Avignon
Clinique Convert
Bourg-en-Bresse
Centre Hospitalier de Chartres
Chartres
Clinique la Mutualiste
Grenoble
Clinique Générale de Marignane
Marignane
Centre Hospitalier de Pau
Pau
Clinique Saint Pierre
Perpignan
Spain7 sites
Hospital Torrecardenas
Almería
Hospital Clinic I Provinvial de Barcelona
Barcelona
Hospital de la Santa Creu i San Pau
Barcelona
Hospital San Pedro de Alcantara
Cáceres
Hospital de Puerta de Hierro
Madrid
Hospital Mexoeiro
Vigo
Hospital Galdakao
Vizcaya
Israel5 sites
Assaf Harofeh Medical Center
Beer Yakov
Carmel Medical Center
Haifa
Rambam Medical Center
Haifa
Kaplan Medical Center
Rehovot
Ziv Medical Center
Safed
Netherlands3 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam
VU Medisch Centrum
Amsterdam
Academisch Ziekenhuis Maastricht
Maastricht
Switzerland3 sites
Centre Hospitalier Universitaire Vaudois
Lausanne
Clinique Cecil
Lausanne
University Hospital Zürich
Zurich
Austria2 sites
Landeskrankenhaus Bruck an der Mur
Bruck an der Mur
Kardinal Schwarzenberg'sches Krankenhaus
Schwarzach Saint Veit
Belgium2 sites
Saint-Pierre University Hospital
Brussels
Cliniques Universitaires UCL de Mont-Godinne
Yvoir
Latvia2 sites
Pauls Stradins Clinical University Hospital
Riga
Riga East Clinical University Hospital
Riga
About this study
Official title: Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial
To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.
- Being tested
- Pro Kinetic Energy bare metal stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro Kinetic Energy bare metal stentDevice
PCI
| Study group | Role | What they receive |
|---|---|---|
| ENERGY-Population | Patient population in standard clinical care, according to the instructions for use and the inclusion / exclusion criteria. Registry patients should be enrolled consecutively to represent a typical set of patients at each site.
The registry will collect clinical data from patients that have given their prior written consent. All data will be anonymized prior to data entry. Receives: Device: Pro Kinetic Energy bare metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)
Measured: 6 months
Secondary outcomes (1)
• MACE after 12 and 24 months • TVR after 6, 12 and 24 months • Stent Thrombosis at 6, 12 and 24 months acc. to the academic research consortium -ARC (13)
Measured: 6,12, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for De Novo and Re-stenosed Coronary Artery LesionsStudies of the same condition, open and under way.
- 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
- 1,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raimund Erbel, MD, Principal investigator, Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056120
- Sponsor's protocol ID
- C0903
- Acronym
- ENERGY
- Status last verified
- Jan 2016
- First submitted
- 25 Jan 2010
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015 Feb;22(1):14-21. doi: 10.1177/1526602814564383.
PubMed 25775674Erbel R, Eggebrecht H, Roguin A, Schroeder E, Philipp S, Heitzer T, Schwacke H, Ayzenberg O, Serra A, Delarche N, Luchner A, Slagboom T; ENERGY Investigators. Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: two-year results of the ENERGY Registry. Cardiovasc Revasc Med. 2014 Nov-Dec;15(8):381-7. doi: 10.1016/j.carrev.2014.10.002. Epub 2014 Oct 15.
PubMed 25456414
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial
- ClinicalTrials.gov ID
- NCT01056120
- Acronym / sponsor ID
- ENERGY / C0903
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,026 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jan 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.
To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENERGY-Population | – | Device: Pro Kinetic Energy bare metal stentPatient population in standard clinical care, according to the instructions for use and the inclusion / exclusion criteria. Registry patients should be enrolled consecutively to represent a typical set of patients at each site. The registry will collect clinical data from patients that have given their prior written consent. All data will be anonymized prior to data entry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (5 listed)
- Patient signed informed consent for data release
- Patient eligible for percutaneous coronary intervention (PCI)
- De novo and re-stenosed coronary artery lesions
- Patient is geographically stable and willing to participate at all follow up assessments
- Patient is > 18 years of age
Key exclusion criteria (3 listed)
- Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel
- Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI
- Patient presents with ISR (in-stent restenosis)
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 |
|---|---|---|
| Pro Kinetic Energy bare metal stentPCI | Device | ENERGY-Population |
Primary outcome
MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)
Time frame: 6 months
1 secondary outcome
• MACE after 12 and 24 months • TVR after 6, 12 and 24 months • Stent Thrombosis at 6, 12 and 24 months acc. to the academic research consortium -ARC (13)
Time frame: 6,12, 24 Months
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 1 Feb 2016.
- Derived from this study: PubMed 25775674Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015 Feb;22(1):14-21. doi: 10.1177/1526602814564383.
- Derived from this study: PubMed 25456414Erbel R, Eggebrecht H, Roguin A, Schroeder E, Philipp S, Heitzer T, Schwacke H, Ayzenberg O, Serra A, Delarche N, Luchner A, Slagboom T; ENERGY Investigators. Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: two-year results of the ENERGY Registry. Cardiovasc Revasc Med. 2014 Nov-Dec;15(8):381-7. doi: 10.1016/j.carrev.2014.10.002. Epub 2014 Oct 15.
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.
Raimund Erbel, MD principal investigator
Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany
50 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of De Novo and Re-stenosed Coronary Artery Lesions, run by Biotronik AG at 50 sites in 10 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 5 inclusion and 3 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 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Germany, France, Spain, Israel, Netherlands and 5 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?
MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) (time frame: 6 months). 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 NCT01056120, which also lists 2 linked publications.
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 1 Feb 2016.