Coronary Artery StenosisPhase 4NCT01182428
XIENCE V: SPIRIT WOMEN Sub-study
A Phase 4 study testing XIENCE V®/ XIENCE PRIME™ and CYPHER SELECT in people with Coronary Artery Stenosis and Coronary Arteriosclerosis, run by Abbott Medical Devices at 25 sites in 15 countries.
Trial summary
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease
- What is being tested?
- XIENCE V®/ XIENCE PRIME™ and CYPHER SELECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 25 sitesin 15 countries
- Study dates
- Sep 2008to Jul 2011
- Phase
- Phase 4
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria:
- Patient must be female.
- Patient must be at least 18 years of age.
- Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
Angiographic Inclusion Criteria:
- Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study stents.
- Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy).
- Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
- Target lesion greater than or equal to 28 mm in length by visual estimate.
General Exclusion Criteria:
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
- Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)
Trial locations and contacts
25 sites in 15 countries.
25 sites in 15 countries
Italy5 sites
Centro Cardiologico Monzino
Milan, 20138
Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
Milan, 20149
Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
Modena, 41100
Ospedale Cisanello
Pisa, 56127
Istituto Clinico Humanitas
Rozzano, 20089
Germany3 sites
Kardiologische Klinik Herz- und Diabeteszentrum
Bad Oeynhausen, 32545
Segebergerkliniken
Bad Segeberg, 23795
Technische Universität Dresden, Medizinische Klinik II - Kardiologie
Dresden, 01307
Argentina2 sites
Hosital Italiano de Buenos Aires - Cardiologia
Buenos Aires, Buenos Aires, 1181
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, 1428
Netherlands2 sites
AMC
Amsterdam, 1105
St. Antonius Ziekenhuis
Nieuwegein, 3430
Spain2 sites
Hospital General de Alicante
Alicante, 3010
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
Switzerland2 sites
Inselspital Bern, Kardiologie
Bern, 3010
Cardiocentro Ticino
Lugano, 6900
Austria1 site
Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
Vienna, 1090
Brazil1 site
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
São Paulo, 04012-180
France1 site
Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
Massy, 91300
Hungary1 site
Semmelweis University, Department of Cardiovascular Surgery
Budapest
Latvia1 site
Latvian Center of Cardiology, P. Stradina University Hospital
Riga, 1002
About this study
Official title: A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.
Read the detailed description
SPIRIT Women Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT Women study after 2 years.
- Conditions
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis, Total Coronary Occlusion, Stent Thrombosis
- Being tested
- XIENCE V®/ XIENCE PRIME™, CYPHER SELECT
- Keywords
- Stents, Angioplasty, Total coronary occlusions, Coronary restenosis, Stent thrombosis, Everolimus
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE V®/ XIENCE PRIME™Device
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
CYPHER SELECTDevice
XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions
| Study group | Role | What they receive |
|---|---|---|
| XIENCE V® / XIENCE PRIME™ | Experimental | Not described Receives: Device: XIENCE V®/ XIENCE PRIME™ |
| CYPHER SELECT | Active comparator | Not described Receives: Device: CYPHER SELECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.
Measured: at 1 year
In-stent Late Loss (LL) (Main Secondary Endpoint)
In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.
Measured: at 270 days
Secondary outcomes (28)
Clinical Device Success
Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.
Measured: Intra-operative
Clinical Procedure Success
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.
Measured: Intra-operative
Adjudicated Stent Thrombosis (Definite, Probable)
Measured: < 1 day (Acute)
Adjudicated Stent Thrombosis (Definite, Probable)
Measured: 1 to 30 days (Sub-Acute)
Adjudicated Stent Thrombosis (Definite, Probable)
Measured: 30 days to 1 year (Late)
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Measured: 30 days to 1 year (Late)
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).
Measured: at 30 days
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Measured: at 240 days
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Measured: at 1 year
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Measured: at 30 days
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Measured: at 240 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Measured: at 30 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Measured: at 240 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Measured: at 1 year
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Measured: at 30 days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Measured: at 240 days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Measured: at 1 year
In-segment Late Loss (LL)
LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up
Measured: at 270 days
In-stent Angiographic Binary Restenosis Rates
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
Measured: at 270 days
In-segment Angiographic Binary Restenosis Rates
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
Measured: at 270 days
In-stent Percent Diameter Stenosis
Measured: at 270 days
In-segment Percent Diameter Stenosis
Measured: at 270 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Measured: at 30 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Measured: at 240 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Measured: at 1 year
Aneurysm
All subjects with aneurysm of the target lesion up to the 270 day follow-up visit
Measured: at 270 days
Thrombus
All subjects with thrombus of the target lesion up to the 270 day follow-up visit
Measured: at 270 days
Persisting Dissection
All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit
Measured: at 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startSep 2008
- Primary completionFeb 2011
- Study completionJul 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie-Claude Morice, Principal investigator, Institut Cardiovasculaire Paris Sud (ICPS), Paris, FranceStephan Windecker, Principal investigator, University Hospital Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182428
- Sponsor's protocol ID
- 07-377 sub-study
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2010
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.
PubMed 19072483Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferre JM, Strasser R, Grinfeld L, Heg D, Juni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.
PubMed 28796809
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT01182428
- Acronym / sponsor ID
- 07-377 sub-study
- Conditions
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis, Total Coronary Occlusion, Stent Thrombosis
- Keywords
- Stents, Angioplasty, Total coronary occlusions, Coronary restenosis, Stent thrombosis, Everolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Aug 2010 (estimated)
- Results
- Posted 13 Jul 2012
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 Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.
Detailed description
SPIRIT Women Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT Women study after 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XIENCE V® / XIENCE PRIME™ | Experimental | Device: XIENCE V®/ XIENCE PRIME™ |
| CYPHER SELECT | Active comparator | Device: CYPHER SELECT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| XIENCE V®/ XIENCE PRIME™Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System | Device | XIENCE V® / XIENCE PRIME™ |
| CYPHER SELECTXIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions | Device | CYPHER SELECT |
Primary outcome
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Time frame: at 1 year
This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.
In-stent Late Loss (LL) (Main Secondary Endpoint)
Time frame: at 270 days
In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.
28 secondary outcomes
Clinical Device Success
Time frame: Intra-operative
Clinical Procedure Success
Time frame: Intra-operative
Adjudicated Stent Thrombosis (Definite, Probable)
Time frame: < 1 day (Acute)
Adjudicated Stent Thrombosis (Definite, Probable)
Time frame: 1 to 30 days (Sub-Acute)
Adjudicated Stent Thrombosis (Definite, Probable)
Time frame: 30 days to 1 year (Late)
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time frame: 30 days to 1 year (Late)
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).
Time frame: at 30 days
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Time frame: at 240 days
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.
Time frame: at 1 year
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Time frame: at 30 days
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
Time frame: at 240 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Time frame: at 30 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Time frame: at 240 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).
Time frame: at 1 year
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 30 days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 240 days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 1 year
In-segment Late Loss (LL)
Time frame: at 270 days
In-stent Angiographic Binary Restenosis Rates
Time frame: at 270 days
In-segment Angiographic Binary Restenosis Rates
Time frame: at 270 days
In-stent Percent Diameter Stenosis
Time frame: at 270 days
In-segment Percent Diameter Stenosis
Time frame: at 270 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Time frame: at 30 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Time frame: at 240 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)
Time frame: at 1 year
Aneurysm
Time frame: at 270 days
Thrombus
Time frame: at 270 days
Persisting Dissection
Time frame: at 270 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19072483Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.
- Derived from this study: PubMed 28796809Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferre JM, Strasser R, Grinfeld L, Heg D, Juni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.
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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.
Marie-Claude Morice principal investigator
Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
Stephan Windecker principal investigator
University Hospital Bern, Bern, Switzerland
25 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XIENCE V®/ XIENCE PRIME™ and CYPHER SELECT in people with Coronary Artery Stenosis and Coronary Arteriosclerosis, run by Abbott Medical Devices at 25 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy, Germany, Argentina, Netherlands, Spain and 10 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2012). 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?
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). (time frame: at 1 year). The study lists 2 primary outcomes in all. 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 NCT01182428, 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 7 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.