Fracture of Stent of Coronary ArteryPROMETEUSNCT01759719
Novara Registry of Platinum-Chromium Platform Stents
An observational study of Fracture of Stent of Coronary Artery and External Causes of Morbidity and Mortality, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Fracture of Stent of Coronary Artery, External Causes of Morbidity and Mortality, Myocardial Infarction
- What is being tested?
- coronary angioplasty with PtCr stent implantation
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Dec 2015
- How long will I take part?
- 1 Year
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 253 consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 with PCI using a platinum-chromium platform based DES
Who may be able to join
- PCI with at least 1 platinum-chromium platform-based stent
- presence of at least 2 ortogonal angiographic projections of the deployed stent to allow proper quantitative coronary angiography
Who cannot join
- age <18 >90
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Maggiore della Carità
Novara, Piedmont, 28100
Alessandro Lupi, M.D., 0039 0321 3733236, lupialessandro1@tin.it
Alessandro Lupi, M.D.
About this study
Official title: Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry
Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms . This analysis aims to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population using quantitative angiographic analysis (QCA).
Read the detailed description
Aims: Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms .
The aim of this analysis is to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population .
Methods: Quantitative angiographic analysis (QCA) of PtCr stents deployed in consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 will be performed by an independent core laboratory. In particular QCA : nominal stent lenght ratio will be calculated for every PtCr stent.
Clinical follow up with data about overall and cardiac mortality, myocardial infarction and target vessel revascularization will also be performed.
- Conditions
- Fracture of Stent of Coronary Artery, External Causes of Morbidity and Mortality, Myocardial Infarction, Coronary Vessel Disorders
- Being tested
- coronary angioplasty with PtCr stent implantation
- Keywords
- platinum-chromium stents, concertina effect, stent deformation, everolimus eluting stents, stent lenght
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary angioplasty with PtCr stent implantationDevice
Also called Promus Elements platinum Chromium stent, Omega platinum Chromium stent
PCI with deployment of at least 1 PtCr stent
| Study group | Role | What they receive |
|---|---|---|
| PtCr stent PCI treated patients | patients treated with PCI in whichat least 1 PtCr stent was used Receives: Device: coronary angioplasty with PtCr stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
QCA : nominal stent lenght ratio
QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation
Measured: 1 day
Secondary outcomes (4)
cardiovascular mortality
death from cardiac or vascular causes
Measured: 1 year
myocardial infarction
recurring myocardial infarction (MI), according to the novel 3rd definition of MI
Measured: 1 year
target vessel failure
any clinically-driver revascularization of the treated coronary vessel
Measured: 1 year
Macroscopical stent deformation
severe stent deformation after deployment or other interventional manouvres (postdilation, IVUS, etc.)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
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 Fracture of Stent of Coronary ArteryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Alessandro Lupi, MD, Principal investigator, AO Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759719
- Sponsor's protocol ID
- 0000002
- Acronym
- PROMETEUS
- Status last verified
- Mar 2015
- First submitted
- 16 Dec 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lupi A, Porto I, Rognoni A, Lazzero M, Fattori R, Parisi R, De Maria GL, Bongo AS, Sheiban I, Bolognese L, Agostoni P, Secco GG; Novara-PROMETEUS (Platinum ChROMium Everolimus EluTing StEnt SpontaneoUs RegiStry) Investigators. Clinical and biomechanical behavior of a platinum-chromium stent platform in a large all-comer single-center population: insights from the Novara-PROMETEUS registry. J Invasive Cardiol. 2014 Jul;26(7):311-7.
PubMed 24993987
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry
- ClinicalTrials.gov ID
- NCT01759719
- Acronym / sponsor ID
- PROMETEUS / 0000002
- Conditions
- Fracture of Stent of Coronary Artery, External Causes of Morbidity and Mortality, Myocardial Infarction, Coronary Vessel Disorders
- Keywords
- platinum-chromium stents, concertina effect, stent deformation, everolimus eluting stents, stent lenght
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Jan 2013 (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.
Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms . This analysis aims to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population using quantitative angiographic analysis (QCA).
Detailed description
Aims: Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms .
The aim of this analysis is to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population .
Methods: Quantitative angiographic analysis (QCA) of PtCr stents deployed in consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 will be performed by an independent core laboratory. In particular QCA : nominal stent lenght ratio will be calculated for every PtCr stent.
Clinical follow up with data about overall and cardiac mortality, myocardial infarction and target vessel revascularization will also be performed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PtCr stent PCI treated patients | – | Device: coronary angioplasty with PtCr stent implantationpatients treated with PCI in whichat least 1 PtCr stent was used |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 253 consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 with PCI using a platinum-chromium platform based DES
Key inclusion criteria (2 listed)
- PCI with at least 1 platinum-chromium platform-based stent
- presence of at least 2 ortogonal angiographic projections of the deployed stent to allow proper quantitative coronary angiography
Key exclusion criteria (1 listed)
- age <18 >90
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 angioplasty with PtCr stent implantationAlso: Promus Elements platinum Chromium stent, Omega platinum Chromium stentPCI with deployment of at least 1 PtCr stent | Device | PtCr stent PCI treated patients |
Primary outcome
QCA : nominal stent lenght ratio
Time frame: 1 day
QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation
4 secondary outcomes
cardiovascular mortality
Time frame: 1 year
myocardial infarction
Time frame: 1 year
target vessel failure
Time frame: 1 year
Macroscopical stent deformation
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Derived from this study: PubMed 24993987Lupi A, Porto I, Rognoni A, Lazzero M, Fattori R, Parisi R, De Maria GL, Bongo AS, Sheiban I, Bolognese L, Agostoni P, Secco GG; Novara-PROMETEUS (Platinum ChROMium Everolimus EluTing StEnt SpontaneoUs RegiStry) Investigators. Clinical and biomechanical behavior of a platinum-chromium stent platform in a large all-comer single-center population: insights from the Novara-PROMETEUS registry. J Invasive Cardiol. 2014 Jul;26(7):311-7.
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.
Alessandro Lupi, MD principal investigator
AO Maggiore della Carita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of Stent of Coronary Artery and External Causes of Morbidity and Mortality, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Lupi, M.D. (0039 0321 3733236, lupialessandro1@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QCA : nominal stent lenght ratio (time frame: 1 day). 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 NCT01759719, 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 26 Mar 2015.