Lower Extremity Occlusive Disease
Conditions
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 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.
Interventions
DEVICEComputer assisted surgery
use of computer assisted surgical device in vascular surgery completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure
Sponsors
Louis A. Weiss Memorial Hospital
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency of Graft Anastomosis | 30 Day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30day, 1 year | death |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Computer Assisted Surgery Computer assisted surgery: use of computer assisted surgical device in vascular surgery
completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 11 |
Baseline characteristics
| Characteristic | Computer Assisted Surgery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 11 participants |
| Sex/Gender, Customized | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Patency of Graft Anastomosis
Time frame: 30 Day
Population: The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data.~Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute.~All efforts have been done to contact the PI and to gather data.
Secondary
Death
death
Time frame: 30day, 1 year
Population: The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data.~Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute.~All efforts have been done to contact the PI and to gather data.
Secondary
Improvement in ABI Measurement of 0.15 or Better
Time frame: 3 month, 6 month, 1 year
Population: The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data.~Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute.~All efforts have been done to contact the PI and to gather data.
Secondary
Time for Femoral Artery Dissection and Anastomosis
Time frame: 1 day
Population: The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data.~Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute.~All efforts have been done to contact the PI and to gather data.