Patient-Specific Simulation Used for EVAR Procedure Rehearsal - Evaluation of Clinical Performance With and Without Prior Rehearsal (PRS)

June 16, 2015 updated by: Simbionix US Corporation

Patient-Specific Simulation Used for Case Rehearsal Prior to EVAR Procedure - Evaluation of Clinical Performance With and Without Prior Rehearsal Using the Procedure Rehearsal Studio. Multi-center Randomized Study

The purpose of this study is to evaluate the procedural and clinical benefits of patient specific pre-procedure rehearsal for operators with various experience levels as a tool for optimizing Endovascular Aneurysm Repair (EVAR) procedures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nancy, France
        • Recruiting
        • C.H.U De Nancy
        • Contact:
          • Nicla Settembre, Md
        • Principal Investigator:
          • Nicla Settembre, MD
  • Italy
      • Bologna, Italy
        • Recruiting
        • Policlinico S. Orsola-Malpighi
        • Contact:
          • Mauro Gargiulo, MD
        • Principal Investigator:
          • Mauro Gargiulo, MD
  • United States
    • Florida
      • Miami, Florida, United States
        • Recruiting
        • Baptist Cardiac and Vascular Institute
        • Contact:
          • Barry T Katzen, MD
        • Contact:
          • Constantino Pena, MD
        • Principal Investigator:
          • Barry T Katzen, MD
      • Tampa, Florida, United States
        • Recruiting
        • University of South Florida, Tampa General Hospital
        • Contact:
          • Murray L Shames, MD
        • Principal Investigator:
          • Murray L Shames, MD
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Holy Name Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • John H. Rundback, MD
    • Ohio
      • Cleveland, Ohio, United States
        • Recruiting
        • University Hospital Case Medical Center
        • Contact:
          • Henry R Baele, MD
        • Principal Investigator:
          • Henry R Baele, MD
      • Columbus, Ohio, United States
        • Recruiting
        • Riverside Methodist Hospital
        • Contact:
          • Gary M Ansel, MD
        • Principal Investigator:
          • Gary M Ansel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects admitted for elective endovascular AAA repair will be randomized

Description

Inclusion Criteria:

  1. At least 18 years old
  2. Elective patients planned to undergo EVAR procedures with an endograft compatible with the Simbionix PRS.
  3. Computed Tomography Angiography (CTA) scan of the abdominal aorta performed as standard of care. Sufficient quality/defined protocol.

Exclusion Criteria:

  1. Subject is below 18 years old
  2. Operator cannot complete the indicated rehearsal and practice.
  3. Patients requiring emergent aneurysm treatment, e.g. trauma or rupture.
  4. Arterial dissection.
  5. Patients with Stage 4 of chronic kidney disease (GFR<30 ml/min/m2).
  6. Patient is indicated for use of snorkels, chimneys, fenestrated or branched graft devices
  7. Pregnant or lactating women.
  8. Off label stent graft use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Control group
Procedure/Surgery : Endovascular Aneurysm Repair with no prior procedure rehearsal
Rehearsal group
Procedure/Surgery : Endovascular Aneurysm Repair with prior procedure rehearsal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Fluoro time
Time Frame: Within 4 hr. after EVAR procedure starts
Within 4 hr. after EVAR procedure starts
Subjective operator perceived effectiveness of prior procedure rehearsal
Time Frame: Within 4 hr. after EVAR procedure starts
Within 4 hr. after EVAR procedure starts

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraprocedural safety measurements
Time Frame: Within 4 hr. after EVAR procedure starts
  1. Overall contrast use (volume)
  2. Skin entry radiation dose
  3. Overall procedure time (from gaining bilateral access until the satisfactory completion of endograft deployment, excluding all adjunctive procedures such as hypogastric embolization, Iliac Percutaneous Transluminal Angioplasty (PTA)/Stenting, sheath removal and hemostasis time)
  4. Procedural blood loss - number of transfused units
  5. Arterial injury (dissection, perforation, rupture, surgical conversion, embolization, none)
Within 4 hr. after EVAR procedure starts
Change in procedure plan
Time Frame: Within 4 hr. after EVAR procedure rehearsal starts
Comparison of treatment plans based on Customary (normal institutional) technique, following 3D reconstruction, and after simulation procedures.
Within 4 hr. after EVAR procedure rehearsal starts
Adjunctive device utilization
Time Frame: Within 4 hr. after EVAR procedure ends
Number and type of used wires, catheters, stent grafts, additional stent graft components and balloons
Within 4 hr. after EVAR procedure ends
Gate cannulation time
Time Frame: Within 3 hr. after EVAR procedure starts
Time to cannulate the contralateral gate with a wire.
Within 3 hr. after EVAR procedure starts
Similarity of simulation to actual case
Time Frame: Within 3 hr. after EVAR procedure ends
  1. Anatomy
  2. Anticipated devices (sizing, tools)
  3. Fluoroscopic Angulations
  4. Case complexity
Within 3 hr. after EVAR procedure ends
General satisfaction- Subjective experience of simulation experience
Time Frame: Within 4 hr. after EVAR procedure ends
  1. Overall ease of use
  2. Controls
  3. Imaging
  4. Device exchanges
  5. Device performance
Within 4 hr. after EVAR procedure ends
Cost analysis
Time Frame: Within the first 30 days after the EVAR procedure
Within the first 30 days after the EVAR procedure
Technical/Clinical success rate
Time Frame: Within the first 30 days after the EVAR procedure
Successful endograft deployment and absence of type 1 or 3 endoleak
Within the first 30 days after the EVAR procedure
Time of simulator rehearsal
Time Frame: Within 3 hr. after EVAR procedure rehearsal ends
Within 3 hr. after EVAR procedure rehearsal ends
Time in ICU
Time Frame: within 30 days after the EVAR procedure
within 30 days after the EVAR procedure
Overall Length of Stay
Time Frame: Within 30 days after the EVAR procedure
Within 30 days after the EVAR procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Simbionix US Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John H. Rundback, MD, Holy Name Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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