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PROMUS Element · 2 trials · 2 indications
A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.
Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium \[ARC\] definitions); see below for definitions of individual components.
| Arm | Type | Description |
|---|---|---|
| PROMUS Element | EXPERIMENTAL | everolimus-eluting coronary stent |
| Experimental Stent | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PROMUS Element | DEVICE | PROMUS Element Everolimus-Eluting Coronary Stent System |
| PROMUS Element™ | DEVICE | Drug eluting coronary stent system |
Inclusion Criteria: * Patient must be at least 20 years of age * Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed * Patient is eligible for percutaneous coronary intervention (PC...
PROMUS Element is an everolimus-eluting coronary stent system used to treat atherosclerosis and coronary artery disease. It is an investigational device being developed by Boston Scientific Corporation. The stent is designed to be implanted in patients with these cardiovascular conditions, and it is currently in Phase 3 clinical development.
PROMUS Element is developed by Boston Scientific Corporation, a company traded on the New York Stock Exchange under the ticker BSX. The company is conducting clinical trials to evaluate the safety and effectiveness of this everolimus-eluting coronary stent system for the treatment of atherosclerosis and coronary artery disease.
PROMUS Element is in Phase 3 clinical development. It is an investigational device, meaning it has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total of 160 patients enrolled across studies conducted in Australia, Malaysia, New Zealand, Singapore, and Japan.
PROMUS Element has been studied in two completed Phase 3 trials. The first, NCT00824434, enrolled 100 patients with atherosclerosis and coronary artery disease in Australia, Malaysia, New Zealand, and Singapore. The second, NCT01080261, enrolled 60 patients in Japan. Both trials were uncontrolled and non-randomized.
PROMUS Element is an everolimus-eluting coronary stent system. It works by delivering everolimus, a drug that helps prevent restenosis, from the stent into the coronary artery wall. The stent provides mechanical support to keep the artery open while the drug inhibits cell proliferation that can cause the artery to narrow again.