Ischemic Heart DiseaseSORT OUT IVNCT00552877
The SOURT OUT IV TRIAL
A study testing Percutaneous coronary intervention (Xience V stent) in people with Ischemic Heart Disease and Coronary Atherosclerosis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher Select+ coronary stents in the treatment of unselected patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Coronary Atherosclerosis, Percutaneous Coronary Intervention
- What is being tested?
- Percutaneous coronary intervention (Xience V stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,678 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Aug 2009
- Phase
- Interventional
- 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
Who may be able to join
- All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.
Who cannot join
- The patient will not participate
- The patient participates in other randomised stent studies
- Expected survival < 1 year
- Allergy to Aspirin, Clopidogrel or Ticlopidine
- Allergy to Sirolimus or ABT-578
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease
In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher Select+ coronary stents in the treatment of unselected patients with coronary artery disease.
Read the detailed description
2 Purpose In a randomized study to compare the Cypher Select+ and the Xience V coronary stents in the treatment of unselected patients with coronary artery disease.
2.1 Primary objective In a randomized study to compare the Xience V and the Cypher Select+ coronary stents by assessing SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) and EFFICACY (target vessel revascularization) after 9 months.
2.2 Secondary objective To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months and the incidence of late stent thrombosis after 12, 24 and 36 months.
- Being tested
- Percutaneous coronary intervention (Xience V stent)
- Keywords
- PCI, Drug-eluting stent
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (Xience V stent)Device
Also called Cypher Select plus coronary stent, Xience V coronary stent
Cypher Select plus coronary stent Xience V coronary stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cypher Select plus stent Receives: Device: Percutaneous coronary intervention (Xience V stent) |
| 2 | Active comparator | Xience V stent Receives: Device: Percutaneous coronary intervention (Xience V stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization)
Measured: 9 months, 1 year, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,678 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Per Thayssen, MD DMSci, Principal investigator, Odense University Hospital, Dept. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552877
- Sponsor's protocol ID
- SOIV-20070043
- Acronym
- SORT OUT IV
- Status last verified
- Aug 2009
- First submitted
- 31 Oct 2007
- Last updated
- 13 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen LO, Thayssen P, Christiansen EH, Maeng M, Ravkilde J, Hansen KN, Hansen HS, Krusell L, Kaltoft A, Tilsted HH, Berencsi K, Junker A, Lassen JF; SORT OUT IV Investigators. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV. J Am Coll Cardiol. 2016 Feb 23;67(7):751-62. doi: 10.1016/j.jacc.2015.11.051.
PubMed 26892409Jensen LO, Thayssen P, Maeng M, Christiansen EH, Ravkilde J, Hansen KN, Kaltoft A, Tilsted HH, Madsen M, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome SORT OUT IV Investigators. Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial. JACC Cardiovasc Interv. 2014 Aug;7(8):840-8. doi: 10.1016/j.jcin.2014.02.014. Epub 2014 Jul 30.
PubMed 25086842Antonsen L, Thayssen P, Hansen HS, Maeng M, Tilsted HH, Botker HE, Ravkilde J, Madsen M, Sorensen HT, Thuesen L, Lassen JF, Jensen LO. Outcomes after revascularisation with everolimus- and sirolimus-eluting stents in patients with acute coronary syndromes and stable angina pectoris: a substudy of the SORT OUT IV trial. EuroIntervention. 2014 Jun;10(2):212-23. doi: 10.4244/EIJV10I2A35.
PubMed 23838425Jensen LO, Thayssen P, Christiansen EH, Tilsted HH, Maeng M, Hansen KN, Kaltoft A, Hansen HS, Botker HE, Krusell LR, Ravkilde J, Madsen M, Thuesen L, Lassen JF; SORT OUT IV Investigators. 2-year patient-related versus stent-related outcomes: the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial. J Am Coll Cardiol. 2012 Sep 25;60(13):1140-7. doi: 10.1016/j.jacc.2012.07.004. Epub 2012 Sep 5.
PubMed 22958957Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Hansen KN, Kaltoft A, Maeng M, Pedersen KE, Kristensen SD, Botker HE, Ravkilde J, Sanchez R, Aaroe J, Madsen M, Sorensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV) Investigators. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012 Mar 13;125(10):1246-55. doi: 10.1161/CIRCULATIONAHA.111.063644. Epub 2012 Feb 3.
PubMed 22308301Jensen LO, Thayssen P, Tilsted HH, Ravkilde J, Junker A, Hansen HS, Hansen KN, Pedersen KE, Sorensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome SORT OUT IV investigators. Rationale and design of a randomized clinical comparison of everolimus-eluting (Xience v/Promus) and sirolimus-eluting (cypher select+) coronary stents in unselected patients with coronary heart disease. Cardiology. 2010;116(2):73-8. doi: 10.1159/000315136. Epub 2010 Jun 3.
PubMed 20523042
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00552877
- Acronym / sponsor ID
- SORT OUT IV / SOIV-20070043
- Keywords
- PCI, Drug-eluting stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,678 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Nov 2007 (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.
In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher Select+ coronary stents in the treatment of unselected patients with coronary artery disease.
Detailed description
2 Purpose In a randomized study to compare the Cypher Select+ and the Xience V coronary stents in the treatment of unselected patients with coronary artery disease.
2.1 Primary objective In a randomized study to compare the Xience V and the Cypher Select+ coronary stents by assessing SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) and EFFICACY (target vessel revascularization) after 9 months.
2.2 Secondary objective To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months and the incidence of late stent thrombosis after 12, 24 and 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Percutaneous coronary intervention (Xience V stent)Cypher Select plus stent |
| 2 | Active comparator | Device: Percutaneous coronary intervention (Xience V stent)Xience V stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.
Key exclusion criteria (5 listed)
- The patient will not participate
- The patient participates in other randomised stent studies
- Expected survival < 1 year
- Allergy to Aspirin, Clopidogrel or Ticlopidine
- Allergy to Sirolimus or ABT-578
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 |
|---|---|---|
| Percutaneous coronary intervention (Xience V stent)Also: Cypher Select plus coronary stent, Xience V coronary stentCypher Select plus coronary stent Xience V coronary stent | Device | 1, 2 |
Primary outcome
SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization)
Time frame: 9 months, 1 year, 2 years, 3 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 13 Aug 2009.
- Derived from this study: PubMed 26892409Jensen LO, Thayssen P, Christiansen EH, Maeng M, Ravkilde J, Hansen KN, Hansen HS, Krusell L, Kaltoft A, Tilsted HH, Berencsi K, Junker A, Lassen JF; SORT OUT IV Investigators. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV. J Am Coll Cardiol. 2016 Feb 23;67(7):751-62. doi: 10.1016/j.jacc.2015.11.051.
- Derived from this study: PubMed 25086842Jensen LO, Thayssen P, Maeng M, Christiansen EH, Ravkilde J, Hansen KN, Kaltoft A, Tilsted HH, Madsen M, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome SORT OUT IV Investigators. Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial. JACC Cardiovasc Interv. 2014 Aug;7(8):840-8. doi: 10.1016/j.jcin.2014.02.014. Epub 2014 Jul 30.
- Derived from this study: PubMed 23838425Antonsen L, Thayssen P, Hansen HS, Maeng M, Tilsted HH, Botker HE, Ravkilde J, Madsen M, Sorensen HT, Thuesen L, Lassen JF, Jensen LO. Outcomes after revascularisation with everolimus- and sirolimus-eluting stents in patients with acute coronary syndromes and stable angina pectoris: a substudy of the SORT OUT IV trial. EuroIntervention. 2014 Jun;10(2):212-23. doi: 10.4244/EIJV10I2A35.
- Derived from this study: PubMed 22958957Jensen LO, Thayssen P, Christiansen EH, Tilsted HH, Maeng M, Hansen KN, Kaltoft A, Hansen HS, Botker HE, Krusell LR, Ravkilde J, Madsen M, Thuesen L, Lassen JF; SORT OUT IV Investigators. 2-year patient-related versus stent-related outcomes: the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial. J Am Coll Cardiol. 2012 Sep 25;60(13):1140-7. doi: 10.1016/j.jacc.2012.07.004. Epub 2012 Sep 5.
- Derived from this study: PubMed 22308301Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Hansen KN, Kaltoft A, Maeng M, Pedersen KE, Kristensen SD, Botker HE, Ravkilde J, Sanchez R, Aaroe J, Madsen M, Sorensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV) Investigators. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012 Mar 13;125(10):1246-55. doi: 10.1161/CIRCULATIONAHA.111.063644. Epub 2012 Feb 3.
- Derived from this study: PubMed 20523042Jensen LO, Thayssen P, Tilsted HH, Ravkilde J, Junker A, Hansen HS, Hansen KN, Pedersen KE, Sorensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome SORT OUT IV investigators. Rationale and design of a randomized clinical comparison of everolimus-eluting (Xience v/Promus) and sirolimus-eluting (cypher select+) coronary stents in unselected patients with coronary heart disease. Cardiology. 2010;116(2):73-8. doi: 10.1159/000315136. Epub 2010 Jun 3.
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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.
Per Thayssen, MD DMSci principal investigator
Odense University Hospital, Dept. of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention (Xience V stent) in people with Ischemic Heart Disease and Coronary Atherosclerosis, run by Odense University Hospital at 1 site in Denmark.
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 5 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 Aug 2009. 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 Denmark. 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?
SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization) (time frame: 9 months, 1 year, 2 years, 3 years). 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 NCT00552877, which also lists 6 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 13 Aug 2009.