Trial to Compare Best Endovascular versus Surgical Therapy in Patients with Critical Limb Ischemia (H-35338)

The purpose of this study is to learn about which therapy is more suitable for those patients with Critical Limb Ischemia (CLI). CLI is usually treated by operations or procedures that increase blood flow to the leg and foot, in order to relieve these symptoms, heal the ulcers, and preserve the limb. There are two different ways to increase the blood flow in CLI. One is with open surgery, which creates a bypass around the blockage. The other is with endovascular treatment (often called angioplasty), a minimally invasive procedure that opens the blocked arteries directly. Angioplasty is performed with balloons and other tools that clear plaque, and sometimes permanent implantation of small, mesh-like metal tubes called stents. Both types of treatment - open surgery and angioplasty - are considered reasonable and appropriate for patients with CLI. NCT: 02060630

Inclusion Criteria:
Age 18 years or older
Critical Limb Ischemia
Patients who are candidates for both open and endovascular surgery.

Exclusion Criteria:
Patients who are not candidates for both open and endovascular surgery.
Current patients on chemotherapy or radiation.
Pregnancy or lactation
Acute limb ischemia.