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CYPHER Sirolimus-Eluting Coronary Stent · 2 trials · 1 indication
In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CYPHER Sirolimus-eluting Coronary Stent | DEVICE | 2.25 Cypher Sirolimus-eluting Coronary Stent |
Inclusion Criteria: 1. Male or non-pregnant female patients minimum 18 years of age 2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ...
CYPHER Sirolimus-Eluting Coronary Stent is used for the treatment of coronary artery disease. It is a drug-eluting stent designed to be implanted in coronary arteries to help keep them open. The device is currently in Phase 3 clinical development and is being developed by Cardinal Health, Inc.
CYPHER Sirolimus-Eluting Coronary Stent elutes sirolimus, an immunosuppressive agent that inhibits cellular proliferation. By releasing sirolimus locally in the coronary artery, the stent aims to reduce restenosis, or re-narrowing of the artery, after implantation. This mechanism is intended to improve long-term patency of the treated vessel.
CYPHER Sirolimus-Eluting Coronary Stent is developed by Cardinal Health, Inc., a company traded on the New York Stock Exchange under the ticker CAH. The company is responsible for the clinical development and commercialization of this coronary stent device for the treatment of coronary artery disease.
CYPHER Sirolimus-Eluting Coronary Stent is in Phase 3 clinical development. It is an investigational device and has not been approved by regulatory authorities. The Phase 3 trials have been completed, and the device is being evaluated for the treatment of coronary artery disease.
CYPHER Sirolimus-Eluting Coronary Stent has been studied in two completed Phase 3 clinical trials. NCT00231244, the SECURE study, enrolled 252 patients with coronary artery disease in the United States. NCT00232739 enrolled 100 patients with coronary artery lesions. Both trials were uncontrolled and have been completed.
CYPHER Sirolimus-Eluting Coronary Stent is a drug-eluting stent, not a bare-metal stent. It is coated with sirolimus, which is released over time to help prevent restenosis. This distinguishes it from bare-metal stents, which do not have a drug coating.