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Promus Element, Promus · 1 trial · 1 indication
The proportion of stent struts uncovered by endothelial tissue will be determined by measuring the number of exposed struts, defined as a measured neointimal hyperplasia (NIH) thickness less than 10 μm, at 0.5 mm cross section analysis, divided by the total number of stent struts. This analysis shall be performed using a dedicated software, as assessed by OCT core lab at 6 month follow up.
| Arm | Type | Description |
|---|---|---|
| Promus Element | EXPERIMENTAL | 21 consecutive patients with Promus Element implanted to treat coronary artery lesion |
| Promus | ACTIVE_COMPARATOR | 21 consecutive patients with Promus stent implanted to treat coronary artery lesions |
| Name | Type | Description |
|---|---|---|
| Promus Element | DEVICE | Promus Element implanted to treat coronary artery lesions. |
| Promus | DEVICE | Promus stent implanted to treat coronary artery lesions |
Inclusion Criteria: * Patient is ≥ 18 years of age * Patient is eligible for percutaneous coronary intervention (PCI) * Patient has documented stable angina pectoris (Canadian Cardiovascular Society \[CCS\] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Br...
Top 11 of 22 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Inclisiran, YMI024 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 4 | PHASE3 | Ziltivekimab |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE3 | Zilebesiran |
| Viatris, Inc. | VTRS | 1 | PHASE3 | Selatogrel |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE3 | obicetrapib+ ezetimibe daily |
| GE Healthcare Technologies Inc. | GEHC | 3 | PHASE1 | Regadenoson |
| Humacyte, Inc. | HUMA | 1 | PHASE2 | CTEV |
| AstraZeneca PLC | AZN | 1 | - | Tezepelumab |
| Sanofi SA Sponsored ADR | SNY | 2 | - | alirocumab |
| Bayer | BAYRY | 1 | PHASE1 | Nurandociguat |
| Hoffmann-La Roche | RHHBY | 1 | PHASE1 | RO7763505 |
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.