Coronary ArteriosclerosisNCT00968019
Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent
An observational study of Coronary Arteriosclerosis, run by Johnson and Johnson, S.A. at 13 sites in 2 countries.
Trial summary
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- Presillion stent
- Type of treatment
- Medical device
- How many people
- 318 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2009to May 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 sujects treated with Presillion stent up to two de novo coronary artery lesions
Who may be able to join
- All subjects treated with Presillion stent up to two de novo coronary artery lesions
Who cannot join
- No specified
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Spain9 sites
Complejo Hospitalario Universitario de Albacete
Albacete, Albacete, 02006
Hospital Germans Trias I Pujol
Badalona, Barcelona, 08916
Centro Medico Teknon
Barcelona, Barcelona, 08022
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, 08025
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Arnau de Vilanova
Lleida, Lerida, 25198
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
Capio Hospital General de Cataluña
Sant Cugat del Vallès, Barcelona, 08195
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Portugal4 sites
Hospital Garcia Da Orta
Almada, 2805-951
Hospital de Santa Cruz
Lisbon, 2799-523
Hospital Sao Joao
Porto, 4200-319
Centro Hospitalar Vila Real
Vila Real, 5000 - 508
About this study
Official title: A Multicenter Postmarket Surveillance Registry Evaluating the Performance and Long Term Safety of the Presillion Stent in de Novo Native Coronary Artery Lesions. Iberian Registry
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
Read the detailed description
Primary endpoint: Composite of Major Adverse Cardiac Events (MACE), which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR) at 12 months follow-up.
Data will be collected on 400 patients (from 14 hospitals in Spain and Portugal) treated with the Presillion stent in up to 2 de novo native coronary artery lesions
Study design: multicenter, prospective, observational
- Conditions
- Coronary Arteriosclerosis
- Being tested
- Presillion stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presillion stentDevice
Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).
| Study group | Role | What they receive |
|---|---|---|
| Presillion stent | Patients treated with the Presillion stent in up to two de novo coronary artery lesions Receives: Device: Presillion stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))
Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR).
The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%).
Measured: at 12 months follow-up
Secondary outcomes (17)
Device Success
Device success defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only
Measured: Peri-procedure up to discharge
Lesion Success
Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.
Measured: Peri-procedure up to discharge
Procedural Success
Procedural success defined as achievement of a final diameter stenosis of <50% (by visual estimate) using any percutaneous method, without the occurrence of death, MI (Myocardial Infarction), or repeat revascularization of the target lesion during the hospital stay
Measured: Peri-procedure up to discharge
Clinically Driven TLR
Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel
Measured: Up to 30 days
Clinically Driven TVR
Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Measured: Up to 30 days
Target Vessel Failure
Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.
Target vessel failure will be reported when:
- MI occurs in territory not clearly attributed to a vessel other than the target vessel.
- Cardiac death not clearly due to a non-target vessel endpoint.
- Target vessel revascularization is performed.
Measured: Up to 30 days
Myocardial Infarction
A positive diagnosis of myocardial infarction is made when one of the following criteria is met:
- Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:
- ischemic symptoms
- ECG changes indicative of ischemia (ST segment elevation or depression)
- Development of pathological Q waves in the ECG
- Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality
- Pathological findings of an acute myocardial infarction
Measured: Up to 30 days
Major Bleeding
Measured: Up to 30 days
Stroke
Measured: Up to 30 days
Stent Thrombosis
Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.
Measured: Up to 30 days
Clinically Driven TLR
Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel
Measured: up to 12 months
Clinically Driven TVR
Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Measured: Up to 12 months
Target Vessel Failure
Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.
Target vessel failure will be reported when:
- MI occurs in territory not clearly attributed to a vessel other than the target vessel.
- Cardiac death not clearly due to a non-target vessel endpoint.
- Target vessel revascularization is performed.
Measured: Up to 12 months
Myocardial Infarction
A positive diagnosis of myocardial infarction is made when one of the following criteria is met:
- Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:
- ischemic symptoms
- ECG changes indicative of ischemia (ST segment elevation or depression)
- Development of pathological Q waves in the ECG
- Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality
- Pathological findings of an acute myocardial infarction
Measured: Up to 12 months
Major Bleeding
Measured: Up to 12 months
Stent Thrombosis
Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.
Measured: Up to 12 months
Stroke
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary ArteriosclerosisStudies 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
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson and Johnson, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angel Cequier, MD, PhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968019
- Sponsor's protocol ID
- 08-CR-001
- Status last verified
- Mar 2013
- First submitted
- 27 Aug 2009
- Last updated
- 13 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Postmarket Surveillance Registry Evaluating the Performance and Long Term Safety of the Presillion Stent in de Novo Native Coronary Artery Lesions. Iberian Registry
- ClinicalTrials.gov ID
- NCT00968019
- Acronym / sponsor ID
- 08-CR-001
- Conditions
- Coronary Arteriosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Johnson and Johnson, S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Posted 6 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
Detailed description
Primary endpoint: Composite of Major Adverse Cardiac Events (MACE), which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR) at 12 months follow-up.
Data will be collected on 400 patients (from 14 hospitals in Spain and Portugal) treated with the Presillion stent in up to 2 de novo native coronary artery lesions
Study design: multicenter, prospective, observational
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Presillion stent | – | Device: Presillion stentPatients treated with the Presillion stent in up to two de novo coronary artery lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All sujects treated with Presillion stent up to two de novo coronary artery lesions
Key inclusion criteria (1 listed)
- All subjects treated with Presillion stent up to two de novo coronary artery lesions
Key exclusion criteria (1 listed)
- No specified
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 |
|---|---|---|
| Presillion stentCenters will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU). | Device | Presillion stent |
Primary outcome
Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))
Time frame: at 12 months follow-up
Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR). The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%).
17 secondary outcomes
Device Success
Time frame: Peri-procedure up to discharge
Lesion Success
Time frame: Peri-procedure up to discharge
Procedural Success
Time frame: Peri-procedure up to discharge
Clinically Driven TLR
Time frame: Up to 30 days
Clinically Driven TVR
Time frame: Up to 30 days
Target Vessel Failure
Time frame: Up to 30 days
Myocardial Infarction
Time frame: Up to 30 days
Major Bleeding
Time frame: Up to 30 days
Stroke
Time frame: Up to 30 days
Stent Thrombosis
Time frame: Up to 30 days
Clinically Driven TLR
Time frame: up to 12 months
Clinically Driven TVR
Time frame: Up to 12 months
Target Vessel Failure
Time frame: Up to 12 months
Myocardial Infarction
Time frame: Up to 12 months
Major Bleeding
Time frame: Up to 12 months
Stent Thrombosis
Time frame: Up to 12 months
Stroke
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Angel Cequier, MD, PhD principal investigator
Hospital Universitari de Bellvitge
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arteriosclerosis, run by Johnson and Johnson, S.A. at 13 sites in 2 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 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, Portugal. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization)) (time frame: at 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2013.