Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01510327 | PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK) | PHASE3 | COMPLETED | 22 | — | — | Oct 1, 2009 | May 1, 2015 | Mar 26, 2019 | 5 | United States, Japan |
| NCT01500434 | The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL) | PHASE3 | COMPLETED | 102 | — | — | Feb 1, 2009 | May 1, 2015 | Mar 26, 2019 | 30 | United States, Australia +5 |
| NCT00823212 | The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions | PHASE3 | COMPLETED | 1,530 | — | — | Jan 1, 2009 | Dec 1, 2014 | Mar 27, 2019 | 133 | United States, Australia +15 |
Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent
Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
| Arm | Type | Description |
|---|---|---|
| PROMUS Element | EXPERIMENTAL | Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique. Total loaded dose of everolimus per stent is dependent on stent size and in this study the administered dose ranged from 60.1 µg to 138.6 µg per stent. Note that the total dose of everolimus administered to a patient is based on the number of stents received and the size of the stent(s). The total dose received per patient ranged from 60.1 µg to 197.8 µg. |
| PROMUS | ACTIVE_COMPARATOR | Patients who received the PROMUS (XIENCE V) Everolimus-Eluting Coronary Stent |
| Name | Type | Description |
|---|---|---|
| PROMUS Element Everolimus-Eluting Coronary Stent System | DEVICE | PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). |
| Aspirin | DRUG | Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter. |
| Thienopyridine | DRUG | Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant. |
| PROMUS Element Coronary Stent System | DEVICE | PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). |
| PROMUS Coronary Stent System | DEVICE | PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). |
Inclusion Criteria: * Patient must be at least 18 years of age * Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed * For patients less than 20 years of age enrolled at...