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...
Top 2 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | REGN7508, REGN9933 |
| Eli Lilly and Company | LLY | 1 | PHASE3 | Orforglipron |
The drug-eluting stent is used to treat coronary artery disease and peripheral artery disease. It is a stent designed to release medication to help keep arteries open. Clinical studies have evaluated it in patients with conditions such as coronary artery disease and peripheral artery disease, including those with de novo artery lesions and bifurcation lesions.
Cardinal Health, Inc. (NYSE: CAH) is the developer of the drug-eluting stent. The company has sponsored clinical trials of the stent for treating coronary artery disease and peripheral artery disease. These trials have been conducted in multiple countries, including France, Germany, and Italy.
The drug-eluting stent is in Phase 3 clinical development for coronary artery disease and peripheral artery disease. It has completed four clinical trials, including Phase 3 studies. The stent is investigational and not yet approved for commercial use based on the available clinical trial data.
The drug-eluting stent has completed four clinical trials. NCT00232830 is a Phase 3 study in coronary artery disease with 715 participants. NCT00232869 is a Phase 2 study in peripheral artery disease with 93 participants. NCT00234455 is a Phase 2 study in coronary artery disease with 86 participants. NCT00381420 is a Phase 3 study in coronary artery disease with 100 participants.
The drug-eluting stent is evaluated in clinical trials under different names, including the Cypher sirolimus-eluting stent and the BX Velocity stent. One completed study, NCT00234455, specifically investigated the Cypher sirolimus-eluting stent for treating bifurcation lesions in coronary artery disease. Another study, NCT00381420, examined the BX Velocity stent for de novo artery lesions.
The drug-eluting stent treats coronary artery disease and peripheral artery disease. Clinical trials have enrolled patients with these conditions, including those with acute myocardial infarction, superficial femoral artery disease, bifurcation lesions, and de novo artery lesions. The studies were randomized, double-blind, and controlled, with a total enrollment of 1,508 participants across all trials.