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GAMMA-Iridium-192 catheter · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| GAMMA-Iridium-192 catheter | DEVICE | - |
Inclusion Criteria: 1. The patient has a restenosis of \>60% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement. 2. The patient has a history, signs of, o...
GAMMA-Iridium-192 catheter is an investigational device being studied for use in coronary artery disease. It delivers localized radiation therapy to inhibit restenosis, which is the re-narrowing of arteries after treatment. The device is in Phase 1 clinical development and is not yet approved by regulatory authorities.
GAMMA-Iridium-192 catheter is being developed by Cardinal Health, Inc., a company traded on the New York Stock Exchange under the ticker symbol CAH. The company is conducting clinical research to evaluate the safety and effectiveness of this investigational device for coronary artery disease.
GAMMA-Iridium-192 catheter is in Phase 1 clinical development. It is an investigational device and has not been approved by the FDA or other regulatory agencies. One clinical trial has been completed, and the device remains under study for the treatment of coronary artery disease.
GAMMA-Iridium-192 catheter has one completed clinical trial registered under NCT00232778, titled "A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)." This Phase 1 trial enrolled 579 participants with coronary artery disease and was not randomized or double-blinded.
GAMMA-Iridium-192 catheter is associated with the GAMMA V clinical trial, which is the study name for the trial NCT00232778. The trial evaluates the device for localized radiation therapy to inhibit restenosis in patients with coronary artery disease. The device itself is the investigational treatment being tested.