Research Study for Adults with Peripheral Artery Disease That Caused Critical Limb Ischemia

IRB/UVA Tracking #
17685
Principal Investigator
Tracci Margaret, C
Official Trial Title
BEST-CLI Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia
Study Description

Critical Limb Ischemia (CLI) is a condition where blood flow to the legs and feet is blocked. When blood flow is blocked to an arm or leg, that limb is in danger of not surviving. . Patients with CLI have limited blood flow to the leg and foot because their PAD has blocked a blood vessel. Surgeons can fix this condition two ways. One way is open surgery to create a new path for blood to reach the foot and leg. The other way is to do “endovascular surgery”. During endovascular surgery, the surgeon goes into a large blood vessel and uses a small hollow tube to insert a balloon into the blocked blood vessel. The balloon is inflated, stretching the narrowed blood vessels open to create more space for the blood to flow. After the balloon is removed, the surgeon may place a metal cage called a stent in to keep the blood vessel open.

UVa Health System is recruiting adults with Peripheral Artery Disease that caused Critical Limb Ischemia for a research study. The purpose of this research study is to learn about which treatment is best for those with CRI. The stents used in this study are approved for use by the FDA, but may not be approved specifically for this treatment. Patients who participate in this study will randomly be assigned one of these two treatments. The researchers will use information from this study to determine which procedure is more suitable and cost effective for future patients.

* You or your insurance company must pay for the costs associated with surgery and hospitalization expenses because these are standard of care and you would have one of these procedures even if you were not in this study.
* There is no charge to you or your insurance company for the procedures and tests which are being done only for research, such as the questionnaires, the pain scale, and the follow up phone calls.
* Patients participating in this study will be compensated up to $400 dollars for participation in this study. Patients will receive $50 after each of the 8 follow up visits.

Contact Information:
For more information please contact the Surgical Therapeutic Advancement Center at:
• Phone 434.243.0315
• Email: uvastac@virginia.edu
• IRB-HSR # 17685

Principal Investigator: Megan Tracci, MD
Department of Surgery Division of Vascular and Endovascular Surgery

Compensation

Up to $400 dollars for participation in this study. Patients will receive $50 after each of the 8 follow up visits.