BEST-CLI Trial

Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI Trial)

Objective

This study is being conducted in partnership with the Midwest Cardiovascular Research Foundation.

The purpose of the study is to learn about which therapy is more suitable for those patients who are candidates for both open surgery and endovascular treatment, and to provide information regarding cost effectiveness of the two different types of treatment.

Participants are eligible for this study when they have been diagnosed with peripheral artery disease (PAD) that has caused critical limb ischemia (CLI). In CLI, arteries that deliver blood to the leg and foot are narrowed or blocked by plaque buildup (atherosclerosis). CLI can cause pain in the foot or leg even when sitting or lying at rest; it also can cause foot and leg ulcerations, and can sometimes lead to gangrene and loss of the leg.

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.

Principal Investigator(s)
Nicholas Shammas

Clinical Trial Categories

  • Cardiac Research
Sponsor(s)
National Heart Lung and Blood Institute (NHLBI)
Contact
Midwest Cardiovascular Research Foundation at 563-324-2828

Location

  • Medical Center, East Rusholme Street
    1227 East Rusholme Street
    Davenport, IA 52803
    Main: 563-421-1000

Contact Us

For more information about our research program and IRB, please contact:

Research Support Office
563-421-7955

Email