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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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Objectives:
Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM
Study period
Primary endpoint
: Target Lesion Failure (TLF) rate at 12 months
Secondary endpoint:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XIENCE PRIMETM everolimus-eluting coronary stent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XIENCE PRIMETM everolimus-eluting coronary stent | Device | Active prospective registration of patients receiving the following stent : XIENCE PRIMETM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) rate at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent & In-segment Late Loss at 9 months | 9 months | |
| Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late) | 24 hours, 30 days, up to 3 years |
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Inclusion Criteria
Angiographic Inclusion Criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung-Woo Park, MD, PhD | Contact | 82-2-2072-0244 | kwparkmd@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hyo-Soo Kim, MD, PhD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31642213 | Derived | Kang J, Han JK, Kang DY, Zheng C, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era. Korean Circ J. 2020 Jan;50(1):22-34. doi: 10.4070/kcj.2019.0097. Epub 2019 Sep 30. |
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| Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years | 30 days, 9 months, 1 year, up to 3 years |
| Composite rate of cardiac death and any MI up to 3 years | up to 3 years |
| Composite rate of all death and any MI up to 3 years | up to 3 years |
| Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years | up to 3 years |
| Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years | up to 3 years |
| procedural success up to 1 day | failure : CK-MB of >3 times the upper limit of normal | 1 day |
| angiographic success up to 1 day | success : a minimum stenosis diameter reduction to <20% in the presence of grade 3 TIMI flow (assessed by angiography) | 1 day |
| 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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