Lower Extremity Occlusive DiseaseNCT01136811

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

A study testing Computer assisted surgery in people with Lower Extremity Occlusive Disease, run by University of Chicago at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lower Extremity Occlusive Disease
What is being tested?: Computer assisted surgery
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 2 sitesUnited States
Study dates: Jun 2009to Mar 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

The University of Chicago
Chicago, Illinois, 60637
Weiss Memorial Hospital
Chicago, Illinois, 60640

Other trials in United States

About this study

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.

Conditions: Lower Extremity Occlusive Disease
Being tested: Computer assisted surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computer assisted surgeryDevice
Also called DaVinci Surgical System
use of computer assisted surgical device in vascular surgery
completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure

Study groups in NCT01136811
Study group	Role	What they receive
Computer assisted surgery	Experimental	Not described Receives: Device: Computer assisted surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Patency of Graft Anastomosis
Measured: 30 Day

Secondary outcomes (3)

Time for Femoral Artery Dissection and Anastomosis
Measured: 1 day
Improvement in ABI Measurement of 0.15 or Better
Measured: 3 month, 6 month, 1 year
Death
death
Measured: 30day, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Mar 2011

First posted3 Jun 2010 (estimated)
Study startJun 2009
Primary completionMar 2011
Study completionMar 2011

Why it stopped: Study was terminated. P.I. left the institution before completing study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lower Extremity Occlusive DiseaseStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01136811
Sponsor's protocol ID: 17002A
Status last verified: Feb 2021
First submitted: 28 May 2010
Last updated: 26 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Recruiting
Construction and Empirical Research of a Risk Prediction Model for Preventing Lower Extremity Arteriosclerosis Obliterans in Diabetic Patients Based on the HAPA Model
Diabetes Mellitus, Peripheral Arterial Disease

All Lower Extremity Occlusive Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures
ClinicalTrials.gov ID: NCT01136811
Acronym / sponsor ID: 17002A
Conditions: Lower Extremity Occlusive Disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated. P.I. left the institution before completing study
Enrolment: 11 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Collaborators: Louis A. Weiss Memorial Hospital
Study start: Jun 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 3 Jun 2010 (estimated)
Results: Posted 26 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Computer assisted surgery	Experimental	Device: Computer assisted surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Computer assisted surgeryAlso: DaVinci Surgical Systemuse of computer assisted surgical device in vascular surgery completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure	Device	Computer assisted surgery

Primary outcome

Patency of Graft Anastomosis
Time frame: 30 Day

3 secondary outcomes

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
Time frame: 30day, 1 year

Results and safety

Results posted to the registry on 26 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Computer Assisted Surgery	11	0

Primary outcome: Patency of Graft Anastomosis

Time frame: 30 Day

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Computer Assisted Surgery	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lower Extremity Occlusive Disease

RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Recruiting
Construction and Empirical Research of a Risk Prediction Model for Preventing Lower Extremity Arteriosclerosis Obliterans in Diabetic Patients Based on the HAPA Model
Diabetes Mellitus, Peripheral Arterial Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Computer assisted surgery in people with Lower Extremity Occlusive Disease, run by University of Chicago at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patency of Graft Anastomosis (time frame: 30 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01136811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.