Infra Renal Aortic AneurysmPRSNCT02151942
Patient-Specific Simulation Used for EVAR Procedure Rehearsal - Evaluation of Clinical Performance With and Without Prior Rehearsal
An observational study of Infra Renal Aortic Aneurysm, run by Simbionix US Corporation at 7 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infra Renal Aortic Aneurysm
- How many people
- 150 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jun 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects admitted for elective endovascular AAA repair will be randomized
Who may be able to join
- At least 18 years old
- Elective patients planned to undergo EVAR procedures with an endograft compatible with the Simbionix PRS.
- Computed Tomography Angiography (CTA) scan of the abdominal aorta performed as standard of care. Sufficient quality/defined protocol.
Who cannot join
- Subject is below 18 years old
- Operator cannot complete the indicated rehearsal and practice.
- Patients requiring emergent aneurysm treatment, e.g. trauma or rupture.
- Arterial dissection.
- Patients with Stage 4 of chronic kidney disease (GFR<30 ml/min/m2).
- Patient is indicated for use of snorkels, chimneys, fenestrated or branched graft devices
- Pregnant or lactating women.
- Off label stent graft use
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States5 sites, 5 recruiting
- Recruiting
University Hospital Case Medical Center
Cleveland, Ohio
Henry R Baele, MD
Henry R Baele, MD
- Recruiting
Riverside Methodist Hospital
Columbus, Ohio
Gary M Ansel, MD
Gary M Ansel, MD
- Recruiting
Baptist Cardiac and Vascular Institute
Miami, Florida
Barry T Katzen, MD
Constantino Pena, MD
- Recruiting
University of South Florida, Tampa General Hospital
Tampa, Florida
Murray L Shames, MD
Murray L Shames, MD
- Recruiting
Holy Name Medical Center
Teaneck, New Jersey, 07666
John H. Rundback, MD, 201-833-7268, jrundback@airsllp.com
Ravit Barkama, MD, 201-541-6312, barkama@mail.holyname.org
France1 site, 1 recruiting
- Recruiting
C.H.U De Nancy
Nancy
Nicla Settembre, Md
Nicla Settembre, MD
Italy1 site, 1 recruiting
- Recruiting
Policlinico S. Orsola-Malpighi
Bologna
Mauro Gargiulo, MD
Mauro Gargiulo, MD
About this study
Official title: 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.
- Conditions
- Infra Renal Aortic Aneurysm
- Keywords
- elective endovascular AAA repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall Fluoro time
Measured: Within 4 hr. after EVAR procedure starts
Subjective operator perceived effectiveness of prior procedure rehearsal
Measured: Within 4 hr. after EVAR procedure starts
Secondary outcomes (11)
Intraprocedural safety measurements
- Overall contrast use (volume)
- Skin entry radiation dose
- 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)
- Procedural blood loss - number of transfused units
- Arterial injury (dissection, perforation, rupture, surgical conversion, embolization, none)
Measured: Within 4 hr. after EVAR procedure starts
Change in procedure plan
Comparison of treatment plans based on Customary (normal institutional) technique, following 3D reconstruction, and after simulation procedures.
Measured: Within 4 hr. after EVAR procedure rehearsal starts
Adjunctive device utilization
Number and type of used wires, catheters, stent grafts, additional stent graft components and balloons
Measured: Within 4 hr. after EVAR procedure ends
Gate cannulation time
Time to cannulate the contralateral gate with a wire.
Measured: Within 3 hr. after EVAR procedure starts
Similarity of simulation to actual case
- Anatomy
- Anticipated devices (sizing, tools)
- Fluoroscopic Angulations
- Case complexity
Measured: Within 3 hr. after EVAR procedure ends
General satisfaction- Subjective experience of simulation experience
- Overall ease of use
- Controls
- Imaging
- Device exchanges
- Device performance
Measured: Within 4 hr. after EVAR procedure ends
Cost analysis
Measured: Within the first 30 days after the EVAR procedure
Technical/Clinical success rate
Successful endograft deployment and absence of type 1 or 3 endoleak
Measured: Within the first 30 days after the EVAR procedure
Time of simulator rehearsal
Measured: Within 3 hr. after EVAR procedure rehearsal ends
Time in ICU
Measured: within 30 days after the EVAR procedure
Overall Length of Stay
Measured: Within 30 days after the EVAR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infra Renal Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simbionix US Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John H. Rundback, MD, Principal investigator, Holy Name Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151942
- Sponsor's protocol ID
- PRS-001
- Acronym
- PRS
- Status last verified
- Jun 2015
- First submitted
- 21 May 2014
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02151942
- Acronym / sponsor ID
- PRS / PRS-001
- Conditions
- Infra Renal Aortic Aneurysm
- Keywords
- elective endovascular AAA repair
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Simbionix US CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Procedure/Surgery : Endovascular Aneurysm Repair with no prior procedure rehearsal |
| Rehearsal group | – | –Procedure/Surgery : Endovascular Aneurysm Repair with prior procedure rehearsal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects admitted for elective endovascular AAA repair will be randomized
Key inclusion criteria (3 listed)
- At least 18 years old
- Elective patients planned to undergo EVAR procedures with an endograft compatible with the Simbionix PRS.
- Computed Tomography Angiography (CTA) scan of the abdominal aorta performed as standard of care. Sufficient quality/defined protocol.
Key exclusion criteria (8 listed)
- Subject is below 18 years old
- Operator cannot complete the indicated rehearsal and practice.
- Patients requiring emergent aneurysm treatment, e.g. trauma or rupture.
- Arterial dissection.
- Patients with Stage 4 of chronic kidney disease (GFR<30 ml/min/m2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Fluoro time
Time frame: Within 4 hr. after EVAR procedure starts
Subjective operator perceived effectiveness of prior procedure rehearsal
Time frame: Within 4 hr. after EVAR procedure starts
11 secondary outcomes
Intraprocedural safety measurements
Time frame: Within 4 hr. after EVAR procedure starts
Change in procedure plan
Time frame: Within 4 hr. after EVAR procedure rehearsal starts
Adjunctive device utilization
Time frame: Within 4 hr. after EVAR procedure ends
Gate cannulation time
Time frame: Within 3 hr. after EVAR procedure starts
Similarity of simulation to actual case
Time frame: Within 3 hr. after EVAR procedure ends
General satisfaction- Subjective experience of simulation experience
Time frame: Within 4 hr. after EVAR procedure ends
Cost analysis
Time frame: Within the first 30 days after the EVAR procedure
Technical/Clinical success rate
Time frame: Within the first 30 days after the EVAR procedure
Time of simulator rehearsal
Time frame: Within 3 hr. after EVAR procedure rehearsal ends
Time in ICU
Time frame: within 30 days after the EVAR procedure
Overall Length of Stay
Time frame: Within 30 days after the EVAR procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
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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.
John H. Rundback, MD principal investigator
Holy Name Medical Center
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infra Renal Aortic Aneurysm, run by Simbionix US Corporation at 7 sites in 3 countries.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, France, Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erez Ben Zvi (+972 54 669 0924, erez.benzvi@3Dsystems.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Fluoro time (time frame: Within 4 hr. after EVAR procedure starts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2015.