Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
drug-eluting stent, bare-metal stent · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent |
| 2 | ACTIVE_COMPARATOR | SMART™ bare-metal stent |
| Name | Type | Description |
|---|---|---|
| drug-eluting stent | DEVICE | Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent |
| bare-metal stent | DEVICE | SMART™ bare-metal stent |
Inclusion Criteria: 1. One superficial femoral artery presenting \> 70% stenosis(es) or total occlusion 2. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4) Exclusion Criteria: 1. Tissue loss due to ischemic disease (Rutherford category 5 or 6). 2. Tandem lesion requir...
A drug-eluting stent is a medical device used to treat coronary artery disease by propping open narrowed or blocked arteries and releasing medication to help prevent the artery from re-narrowing. It is also used in peripheral artery disease. The stent is implanted during a procedure to restore blood flow.
The drug-eluting stent is developed by Cardinal Health, Inc., a company traded on the New York Stock Exchange under the ticker symbol CAH. Cardinal Health is the developer of this investigational device, which is being studied for use in cardiovascular conditions.
The drug-eluting stent is in Phase 3 clinical development. It is an investigational device, meaning it has not yet been approved by regulatory authorities. It is being studied in clinical trials for the treatment of coronary artery disease and peripheral artery disease.
The drug-eluting stent has been studied in four completed clinical trials, including NCT00232830, NCT00234455, NCT00235170, and NCT00381420. These trials enrolled a total of 1,508 participants and focused on coronary artery disease, with some trials conducted in France, Germany, Italy, and the Netherlands.
The drug-eluting stent is a general category of stent, and one of its clinical trials specifically studied the Cypher sirolimus-eluting stent. The Cypher stent is a type of drug-eluting stent that releases sirolimus to prevent artery re-narrowing. The developer of the drug-eluting stent is Cardinal Health.
The drug-eluting stent is not FDA approved. It is an investigational device currently in Phase 3 clinical development. It has completed four clinical trials, but approval status has not been established. The device is being studied for coronary artery disease and peripheral artery disease.