The purpose of this study is to evaluate the preliminary safety and efficacy of the daVinci surgical system (computer-assisted surgery) for use in vascular surgery procedures. Although the daVinci Surgical System is FDA approved and widely used for surgical procedures for urology, cardiac, general, and gynecologic procedures, it is not currently approved specifically for use in vascular surgery and the FDA has required the PI to conduct a small feasibility study under an IDE. The investigators are seeking approval by the FDA to utilize the daVinci Surgical System in vascular surgery and to conduct a future clinical trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
11
use of computer assisted surgical device in vascular surgery completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure
The University of Chicago
Chicago, Illinois, United States
Weiss Memorial Hospital
Chicago, Illinois, United States
Patency of Graft Anastomosis
Time frame: 30 Day
Time for Femoral Artery Dissection and Anastomosis
Time frame: 1 day
Improvement in ABI Measurement of 0.15 or Better
Time frame: 3 month, 6 month, 1 year
Death
death
Time frame: 30day, 1 year
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