Abdominal Aortic Aneurysm (AAA)EVARNCT02934087
Endovascular Aneurysm Repair (EVAR) Gate Study
A study testing Endovascular Aneurysm Repair in people with Abdominal Aortic Aneurysm (AAA), run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
This study will evaluate a randomized comparison of direct versus snare techniques for cannulation of contralateral gate during an endovascular aneurysm repair (EVAR) procedure. This information will be used to determine if primary snaring is superior to retrograde cannulation in decreasing procedural time and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm (AAA)
- What is being tested?
- Endovascular Aneurysm Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Mar 2014
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18
- Patient is undergoing EVAR repair with a commercially available endograft
- Willing to give consent
- Procedure is Elective
Who cannot join
- Declines to participate
- Unable to provide consent
- Urgent AAA repair
- Participating in another study
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
About this study
Official title: Evaluation of a Randomized Comparison of Direct Versus Snare Techniques for Cannulation of Contralateral Gate During an Endovascular Aneurysm Repair (EVAR) Procedure
This study will evaluate a randomized comparison of direct versus snare techniques for cannulation of contralateral gate during an endovascular aneurysm repair (EVAR) procedure.
This information will be used to determine if primary snaring is superior to retrograde cannulation in decreasing procedural time and radiation exposure.
Read the detailed description
Endografts currently FDA-approved for abdominal aortic aneurysm (AAA) repair are modular systems,comprised of a main body (Aortic Trunk) and two legs (Ipsilateral Leg Endoprosthesis and a contralateral leg endoprosthesis). In placement of the endograft the main body and ipsilateral limb are deployed from a retrograde common femoral artery approach. From the contralateral femoral artery, cannulation of the contralateral gate is required to deploy the contralateral iliac limb.Cannulation of the contralateral limb gate is the portion of the operation that requires the most "wire skills." Depending on the patients' body type, angulations of the aorta and the size and volume of the AAA, this portion of the procedure can be technically difficult. This portion may become lengthy and discouraging if the surgeon fails to cannulate the gate using a particular approach. Cannulation of the contralateral limb gate from a retrograde femoral artery approach is commonly achieved by first using a maneuverable guidewire and steerable catheter. Antegrade or crossover cannulation involves passing a guidewire from the ipsilateral limb to the contralateral limb gate of the endograft, which can be accomplished with a curved catheter. The wire may be retrieved on the contralateral limb using a snare device. The problem and why it is important -- difficulty in accessing the contralateral gate leads to increase procedural time and excess exposure to radiation. The standard of care is retrograde cannulation with the use of crossover snare techniques as a secondary adjunct if retrograde cannulation fails. In this study we will compare retrograde cannulation to primary snaring.
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Being tested
- Endovascular Aneurysm Repair
- Keywords
- snare technique, cannulation of contralateral gate, endovascular, aneurysm, AAA, Abdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aneurysm RepairProcedure or surgery
Also called EVAR
Endovascular aneurysm repair (or endovascular aortic repair) (EVAR) is a type of endovascular surgery used to treat pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA)
| Study group | Role | What they receive |
|---|---|---|
| Retrograde Gate Cannulation | Active comparator | All patients undergoing elective EVAR with a standard commercially available stent graft will be randomized after informed consent obtained; gate cannulation method will be attempted for a period of 15 minutes. If unsuccessful during this time a crossover to the alternative method (snare) will be attempted. The study will be terminated at 15 minutes in the crossover arm if still unsuccessful. Receives: Procedure: Endovascular Aneurysm Repair |
| Snare Technique | Active comparator | All patients undergoing elective EVAR with a standard commercially available stent graft were randomized after informed consent obtained; gate cannulation method was attempted for a period of 15 minutes. If unsuccessful during this time a crossover to the alternative method (retrograde gate cannulation) was attempted. The study will be terminated at 15 minutes in the crossover arm if still unsuccessful.
Antegrade or crossover cannulation involves passing a guidewire from the ipsilateral limb to the contralateral limb gate of the endograft, which can be accomplished with a curved catheter. The wire may be retrieved on the contralateral limb using a snare device. Receives: Procedure: Endovascular Aneurysm Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: Time to contralateral gate cannulation
The patient will be randomized to either a snare or retrograde technique in a 1:1 ratio intraoperatively at the time of deployment of the main body of the graft. The timer will be started at 0 when positioning catheter is withdrawn from para-renal position into sac. The timer will be stopped after successful gate cannulation or after 30 minutes of fluoroscopy time.
Measured: Intra-operatively comparing the time to contralateral gate cannulation (snare or retrograde techniques) .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysm (AAA)Studies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Titus, MD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934087
- Sponsor's protocol ID
- EV001
- Acronym
- EVAR
- Status last verified
- Oct 2016
- First submitted
- 5 Aug 2011
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Randomized Comparison of Direct Versus Snare Techniques for Cannulation of Contralateral Gate During an Endovascular Aneurysm Repair (EVAR) Procedure
- ClinicalTrials.gov ID
- NCT02934087
- Acronym / sponsor ID
- EVAR / EV001
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Keywords
- snare technique, cannulation of contralateral gate, endovascular, aneurysm, AAA, Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Oct 2016 (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.
This study will evaluate a randomized comparison of direct versus snare techniques for cannulation of contralateral gate during an endovascular aneurysm repair (EVAR) procedure.
This information will be used to determine if primary snaring is superior to retrograde cannulation in decreasing procedural time and radiation exposure.
Detailed description
Endografts currently FDA-approved for abdominal aortic aneurysm (AAA) repair are modular systems,comprised of a main body (Aortic Trunk) and two legs (Ipsilateral Leg Endoprosthesis and a contralateral leg endoprosthesis). In placement of the endograft the main body and ipsilateral limb are deployed from a retrograde common femoral artery approach. From the contralateral femoral artery, cannulation of the contralateral gate is required to deploy the contralateral iliac limb.Cannulation of the contralateral limb gate is the portion of the operation that requires the most "wire skills." Depending on the patients' body type, angulations of the aorta and the size and volume of the AAA, this portion of the procedure can be technically difficult. This portion may become lengthy and discouraging if the surgeon fails to cannulate the gate using a particular approach. Cannulation of the contralateral limb gate from a retrograde femoral artery approach is commonly achieved by first using a maneuverable guidewire and steerable catheter. Antegrade or crossover cannulation involves passing a guidewire from the ipsilateral limb to the contralateral limb gate of the endograft, which can be accomplished with a curved catheter. The wire may be retrieved on the contralateral limb using a snare device. The problem and why it is important -- difficulty in accessing the contralateral gate leads to increase procedural time and excess exposure to radiation. The standard of care is retrograde cannulation with the use of crossover snare techniques as a secondary adjunct if retrograde cannulation fails. In this study we will compare retrograde cannulation to primary snaring.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrograde Gate Cannulation | Active comparator | Procedure: Endovascular Aneurysm RepairAll patients undergoing elective EVAR with a standard commercially available stent graft will be randomized after informed consent obtained; gate cannulation method will be attempted for a period of 15 minutes. If unsuccessful during this time a crossover to the alternative method (snare) will be attempted. The study will be terminated at 15 minutes in the crossover arm if still unsuccessful. |
| Snare Technique | Active comparator | Procedure: Endovascular Aneurysm RepairAll patients undergoing elective EVAR with a standard commercially available stent graft were randomized after informed consent obtained; gate cannulation method was attempted for a period of 15 minutes. If unsuccessful during this time a crossover to the alternative method (retrograde gate cannulation) was attempted. The study will be terminated at 15 minutes in the crossover arm if still unsuccessful. Antegrade or crossover cannulation involves passing a guidewire from the ipsilateral limb to the contralateral limb gate of the endograft, which can be accomplished with a curved catheter. The wire may be retrieved on the contralateral limb using a snare device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Patient is undergoing EVAR repair with a commercially available endograft
- Willing to give consent
- Procedure is Elective
Key exclusion criteria (4 listed)
- Declines to participate
- Unable to provide consent
- Urgent AAA repair
- Participating in another study
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 |
|---|---|---|
| Endovascular Aneurysm RepairAlso: EVAREndovascular aneurysm repair (or endovascular aortic repair) (EVAR) is a type of endovascular surgery used to treat pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA) | Procedure or surgery | Retrograde Gate Cannulation, Snare Technique |
Primary outcome
Primary Endpoint: Time to contralateral gate cannulation
Time frame: Intra-operatively comparing the time to contralateral gate cannulation (snare or retrograde techniques) .
The patient will be randomized to either a snare or retrograde technique in a 1:1 ratio intraoperatively at the time of deployment of the main body of the graft. The timer will be started at 0 when positioning catheter is withdrawn from para-renal position into sac. The timer will be stopped after successful gate cannulation or after 30 minutes of fluoroscopy time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Abdominal Aortic Aneurysm (AAA)
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
Jessica Titus, MD principal investigator
Minneapolis Heart Institute Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Aneurysm Repair in people with Abdominal Aortic Aneurysm (AAA), run by Minneapolis Heart Institute Foundation at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Endpoint: Time to contralateral gate cannulation (time frame: Intra-operatively comparing the time to contralateral gate cannulation (snare or retrograde techniques) .). 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 14 Oct 2016.