Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Orsiro™ or Orsiro_Mission™ stents have the biodegradable polymer and the thinnest stent strut (60㎛) in commercially available stents, which could minimize chronic inflammation and incomplete endothelialization. In several prior studies, ultrathin strut sirolimus-eluting stent (Orsiro®) showed better outcomes in terms of target lesion failure or target lesion revascularization compared to other contemporary stents. Chronic kidney disease (CKD) is known to be associated with adverse cardiovascular outcome including restenosis or stent thrombosis following percutaneous coronary interventin (PCI), because the patients with CKD have more complex coronary lesion characteristics, severe calcification, and diffuse plaque of the coronary artery. However, there is a paucity of data regarding clinical efficacy of Orsiro® in CKD population. Therefore, this study aims to investigate the differences in clinical outcomes according to renal function in patients undergoing PCI with Orsiro™ or Orsiro_Mission™ stents. After patients will be divided into three groups according to the renal function; normal or mild renal dysfunction (eGFR ≥ 60 ml·min - 1·1.73㎡), moderate renal dysfunction ( 30≤ eGFR< 60 ml·min - 1·1.73㎡), and severe renal dysfunction (eGFR < 30 ml·min -1·1.73㎡), the clinical outcome will be investigated among groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal or mild renal dysfunction | Experimental | eGFR ≥ 60 ml·min - 1·1.73㎡ |
|
| Moderate renal dysfunction | Experimental | 30≤ eGFR< 60 ml·min - 1·1.73㎡ |
|
| Severe renal dysfunction | Experimental | eGFR < 30 ml·min -1·1.73㎡ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Procedure | Percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target-lesion failure (TLF) | Number of participants with Target-lesion failure (TLF), defined as composite of cardiac death, target vessel-related myocardial infarction (TVMI) and ischemia-driven target-lesion revascularization (TLR) at 1 year | Within one year after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with all cause death | Within three years after the intervention | |
| Number of participants with cardiac death | Within three years after the intervention | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mahn-Won Park | Daejeon St. Mary's Hospital , The Catholic University of Korea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejeon St. Mary's Hospital , The Catholic University of Korea | Daejeon | South Korea |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Orsiro™ or Orsiro_Mission™ stent | Device | Percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents |
|
| Number of participants with myocardial infarction |
periprocedural or spontaneous |
| Within three years after the intervention |
| Number of participants with composite of death or myocardial infarction | Within three years after the intervention |
| Number of participants with composite of cardiac death or myocardial infarction | Within three years after the intervention |
| Number of participants with target-vessel revascularization | Within three years after the intervention |
| Number of participants with target-lesion revascularization | Within three years after the intervention |
| Number of participants with stent thrombosis | Stent thrombosis appropriate for Academic Research Consortium criteria | Within three years after the intervention |
| Number of participants with target-vessel failure | composite of composite of death, nonfatal myocardial infarction and ischemia-drive target-vessel revascularization (TVR) | Within three years after the intervention |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |