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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Primeâ„¢, with the Platinum Chromium platform everolimus-eluting stent, Promus Elementâ„¢, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography.
Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cobalt Chromium Everolimus-eluting stent (Xience Prime) | Active Comparator | Cobalt Chromium Everolimus-eluting stent (Xience Prime) |
|
| Platinum Chromium Everolimus-eluting stent (Promus Element) | Active Comparator | Platinum Chromium Everolimus-eluting stent (Promus Element) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus eluting stents | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation | Immediately following stent deployment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of uncovered stent struts | 6 mths post initial PCI procedure | |
| Mean neointimal tissue thickness (microns) | 6 months post initial PCI Procedure | |
| Stent length (mm) measured using OCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Barlis, MBBS MPH PHD FESC FRACP | Contact | +61 3 8405 8554 | pbarlis@unimelb.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Peter Barlis | Northern Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concord Repatriation Hospital | Not yet recruiting | Concord | New South Wales | Australia |
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| 6 months post initial PCI procedure |
| The Prince Charles Hospital | Not yet recruiting | Brisbane | Queensland | Australia |
|
| Northern Hospital | Recruiting | Epping | Victoria | 3076 | Australia |
|
| St Vincent's Hospital | Not yet recruiting | Melbourne | Victoria | 3065 | Australia |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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