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The superiority of a percutaneous coronary intervention (PCI) by one stent over another in terms of clinical outcome is usually documented in large randomized controlled trials (RCT). Although generated from selected study populations these data form the basis for evidence based practice (EBP) in the entire population of patients considered for coronary intervention. An inherent limitation of this approach is that study populations differ significantly from all comers in terms of patient characteristics and prognosis undermining the foundation for extrapolation of trial results to all comers. Furthermore, other trials are based on a "one-fits-all" concept, while the benefits of an "individual-tailored" approach that might be superior, is not investigated.
The Purpose of the current study is to
The Method employed is
Outcome Measures
Primary endpoints:
Secondary outcome measures include each of the above, target lesion revascularisation and total death analyzed in a hierarchical fashion at 2, 3, 4 and 5 years.
Tertiary outcome measure is self reported quality of life based on health questionnaires on general health and cardiac symptoms.
Power Calculations An event rate of 20% within 5 years, a relative difference of 25% (an absolute difference of 5%), P< 5%, Power > 80% => 900 patients in each of two treatment arms.
Prespecified Analysis include
All MACE and stent thromboses are adjudicated by an independent end point and safety committee chaired by Jørgen Jeppesen known from the very same task he executed in the SORT OUT II.
Further question may be answered by the four key investigators:
Steen Carstensen, Anders Galløe, Ole Havndrup, Lars Kjøller-Hansen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group two | Active Comparator | Endeavor resolute drug eluting stent |
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| Study group three | Active Comparator | The precise selection of brand name depends on negotiations with suppliers and may change during the study period |
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| Study group four | Active Comparator | The precise selection of brand name depends on negotiations with suppliers and may change during the study period |
|
| Study group five | Active Comparator | The precise selection of brand name depends on negotiations with suppliers and may change during the study period |
|
| Study group one | Active Comparator | The precise selection of brand name depends on negotiations with suppliers and may change during the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomatrix drug eluting stent | Device | Biomatrix drug eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation | Five year |
| Stent thromboses | Definite, propable and possible | Five year |
| Treatment failure | A specifically developed Treatment Failure Classification | Five Years |
| Measure | Description | Time Frame |
|---|---|---|
| Death of any cause | Ongoing quality assurance | One and five years |
| Self reported health questionnaires on general health and cardiac specific symptoms. | One and five years |
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Inclusion Criteria:
Exclusion Criteria to randomization:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anders M Galløe, MD.Ph.D. | Contact | +45 47 32 60 22 | anders@galloe.dk | |
| Steen Carstensen, MD.Ph.D. | Contact | +45 47 32 60 11 | sct@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Anders M Galløe, Md.Ph.D. | Zealand University Hospital | Principal Investigator |
| Steen Carstensen, MD | Zealand University Hospital | Study Chair |
| Ole Havndrup, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roskilde County Hospital | Roskilde | 4000 | Denmark |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Cardiac death | One and five years |
| Myocardial infarction | One and five years |
| Target lesion revascularisation | One and five years |
| Target vessel revascularisation | One and five years |
| Stent thrombosis | One and five years |
| Treatment Failure | One and five years |
| Zealand University Hospital |
| Study Chair |
| Lars Kjøller-Hansen, MD | Zealand University Hospital | Study Chair |
| Gunnar VH Jensen, MD | Zealand University Hospital | Study Director |
| Jørgen Jeppesen, MD | Glostrup University Hospital, Copenhagen | Study Director |