Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures

Conditions
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Lower Extremity Occlusive Disease

Intervention / Treatment
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* Device: Computer assisted surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer assisted surgery<br> | Device: Computer assisted surgery<br>* use of computer assisted surgical device in vascular surgery completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure<br>* Other names: DaVinci Surgical System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of Graft Anastomosis |  | 30 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for Femoral Artery Dissection and Anastomosis |  | 1 day | 
| Improvement in ABI Measurement of 0.15 or Better |  | 3 month, 6 month, 1 year | 
| Death | death | 30day, 1 year |