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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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Drug eluting stents (DES) are widely used for treatment of coronary artery lesions. The Xience Sierra stent has a refined design of the metal stent backbone and is used in patients with various clinical syndromes and in different lesions. Clinical outcome of patients with previously unknown (silent) diabetes and prediabetes is of increasing interest since the latter group has recently shown to be associated with a significant risk of adverse cardiovascular events after treatment with contemporary DES. Outcome data in a population of high-risk all-comer patients, including many patients with diabetes mellitus and prediabetes, would be of great interest, but such data are not available yet. In addition, there is a lack of data in a general all-comer population. Therefore, the COASTLINE study will primarily assess the safety and efficacy of the Xience Sierra stent in a general all-comer population as well as a high-risk all-comer population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All-comer patients requiring PCI | All-comer patients requiring percutaneous coronary intervention (PCI) for the treatment of significant coronary artery of bypass graft lesions that are suitable for treatment with Xience Sierra DES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Device | PCI for treatment of coronary or bypass graft lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure (TVF) at 1-year follow up in complex all-comers | TVF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization. | 1 year |
| Target lesion failure (TLF) at 2-year follow up in all-comers | TLF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target lesion revascularization. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| TVF at 2 year follow up | 2 year | |
| Death | any/cardiac/non-cardiac | up to 3 year |
| Myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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All-comers. Patients for elective PCI or acute PCI
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxcentrum Twente | Enschede | Netherlands | ||||
| Haga Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41230396 | Derived | van Vliet D, Ploumen EH, Pinxterhuis TH, Buiten RA, Aminian A, Schotborgh CE, Anthonio RL, Zocca P, Hartmann M, Stoel MG, de Man FHAF, Linssen GCM, Doggen CJM, van der Heijden LC, Kok MM, von Birgelen C. Complex all-comers and patients with diabetes and prediabetes treated with Xience Sierra everolimus-eluting stents: COASTLINE high-risk. Eur Heart J Open. 2025 Oct 21;5(6):oeaf140. doi: 10.1093/ehjopen/oeaf140. eCollection 2025 Nov. |
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target vessel related/any/periprocedural |
| up to 3 year |
| Clinically indicated target vessel revascularization | up to 3 year |
| Clinically indicated target lesion revascularization | up to 3 year |
| The Hague |
| Netherlands |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000787 | Angina Pectoris |
| D000789 | Angina, Unstable |
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| D023903 | Coronary Restenosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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