| Clinical Trials | |
| Title: | FREEDOM Trial |
| Purpose: | The purpose of this study is to compare two different methods of treatment for patients with diabetes mellitus and coronary artery disease in more than one heart vessel. The study seeks to evaluate whether drug-eluding stenting is more or less effective than coronary artery bypass surgery (CABG). |
| Study Number: | 108974 |
| Number of Patients: | 20 |
| Elgibility: | Eligible patients with be diabetic (type 1 or 2) with multivessel heart disease that requires medical intervention. Patients must meet medical criteria for both the stenting and bypass procedures prior to enrollment, because it is unknown which treatment will be administered prior to enrollment. |
| Treatment: | Patients assigned to coronary artery bypass surgery (CABG) will receive general anesthesia and will have a breathing tube placed in the throat for the surgical procedure. This procedure begins with an incision through the chest bone and muscle. The surgeon will use one or more healthy vessels and will bypass the diseased vessel with these healthy vessel(s). This bypass will provide needed blood supply to the heart. Additional tests will be performed following the surgery. Patients also will receive various medications to prevent blood clotting. This recommended treatment is not FDA-approved for bypass surgery patients. The hospital stay routinely lasts between two and seven days. Patients assigned to the drug-eluding stenting procedure will have two or more drug-eluding stents permanently implanted in the clogged arteries. The medication that coats the stent prevents reclogging of the arteries. Patients will receive a local anesthetic at the top of the leg (groin area) or in the forearm, and they will be awake for the procedure. A small puncture/incision will be made at this site, and a small, flexible, balloon-tipped catheter (a hollow tube) is introduced. The balloon catheter will be positioned using X-ray and contrast dye (a clear liquid that is injected into the blood vessel). After enlarging the vessel, the drug-eluding stent will be placed in the narrowed part of the coronary artery. Additional balloon inflations may be necessary in order to fully expand the stent. Once the stent is fully expanded, the balloon is deflated and removed, leaving the stent in place in the artery. Additional tests will be performed following the surgery. Patients will receive various medications to prevent blood clotting. The hospital stay may be one to two days. |
| Principal Investigator: | Fred Leya, M.D. |
| Enrollment Phone: | (708) 327-2761 |