Status:
TERMINATED
Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Louis A. Weiss Memorial Hospital
Conditions:
Lower Extremity Occlusive Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Sur...
Eligibility Criteria
Inclusion
- Patients with significant femoropopliteal or tibial occlusive disease not amenable to catheter directed therapy (ie angioplasty/stenting). Symptoms include lifestyle-limiting claudication, rest pain and/or tissue loss.
- Patients with an ABI between 0.2 and 0.8.
- Femoropopliteal disease visible on color duplex ultrasound (DUS)
- Patent and minimally diseased common femoral and proximal superficial artery
- Patients with American Society of Anesthesiology (ASA) I, II or III classification
- PT/PTT, EKG, HbA1c, liver function, within normal ranges within 30 days prior to procedure or stable over the last 6 months.
- Current University of Chicago Medical Center Lab standards will be used. Pulmonary function will be assessed as needed by preoperative anesthesia evaluation. (Generally for infrainguinal procedures, pulmonary function is not assessed)
- Body Mass Index (BMI) \<40
Exclusion
- Previous surgery in the inguinal region (ie: prior femoral artery dissection)
- Myocardial infarction (MI) within the last 6 months
- Laboratory evidence of hypercoagulable state and/or connective tissue disease
- Pregnant women
- History of non-compliance with medical care
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01136811
Start Date
June 1 2009
End Date
March 1 2011
Last Update
February 26 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Chicago
Chicago, Illinois, United States, 60637
2
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640