Abdominal Aortic AneurysmPEVARNCT01070069
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
A study testing PEVAR (ProGlide closure), SEVAR (IntuiTrak) and PEVAR (Prostar XL closure) in people with Abdominal Aortic Aneurysm, run by Endologix at 20 sites in United States.
Trial summary
To determine the safety and effectiveness of PEVAR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- PEVAR (ProGlide closure), SEVAR (IntuiTrak) and PEVAR (Prostar XL closure)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 20 sitesUnited States
- Study dates
- 13 Apr 2010to 5 Sep 2012
- 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
- Male or female at least 18 years old
- Informed consent form understood and signed and patient agrees to all follow-up visits
- Abdominal aortic aneurysm (AAA) with maximum diameter ≥5cm, or in the range of 4 to 5cm which has increased by 0.5cm or more in the past six months
- Have a suitable ipsilateral common femoral artery for percutaneous access using a 'Pre-close' technique as detailed in the protocol
- Anatomically eligible for the IntuiTrak System per the FDA-approved indications for use (IFU)
Who cannot join
- Life expectancy <1 year as judged by the investigator;
- Psychiatric or other condition that may interfere with the study;
- Participating in the enrollment or 30-day follow-up phase of another clinical study;
- Known allergy to any device component;
- Coagulopathy or uncontrolled bleeding disorder;
- Ruptured, leaking, or mycotic aneurysm;
Show all 23Show fewer
- Serum creatinine (S-Cr) level >1.7 mg/dL;
- Traumatic vascular injury;
- Active systemic or localized groin infection;
- Connective tissue disease (e.g., Marfan's Syndrome);
- Renal transplant patient;
- Recent (within prior three months) cerebrovascular accident or myocardial infarction;
- Planned major intervention or surgery within 30 days following the EVAR procedure;
- Requirement for an arterial conduit at the access site;
- Morbidly obese (BMI≥40);
- Calcification throughout the common femoral artery (CFA) target area anterior wall or circumferentially or over >50% of the posterior wall;
- Femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm;
- Evidence of prior common femoral artery surgery (e.g., groin incision);
- Prior clip-based vascular closure device placement in either arterial access site;
- Collagen-based vascular closure device placement in either arterial access site within the prior 90 days;
- Femoral artery needle puncture in either arterial access site within the prior 30 days;
- Hematoma at the ipsilateral arterial access site
- Significant scarring at the ipsilateral arterial access site
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Mission Hospital
Asheville, North Carolina, 28801
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
Mercy Hospital
Chicago, Illinois, 60616
Cleveland Clinic
Cleveland, Ohio, 44195
Dallas VA Medical Center
Dallas, Texas, 75216
Inova Fairfax
Falls Church, Virginia, 22042
Holy Cross Medical Center
Fort Lauderdale, Florida, 33308
VA Gainesville
Gainesville, Florida, 32608
Forrest General Hospital
Hattiesburg, Mississippi, 39401
St. Luke's Hospital at Texas Heart Institute
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Loma Linda VA Medical Center
Loma Linda, California, 92357
University of Wisconsin
Madison, Wisconsin, 53792
VA Miami
Miami, Florida, 33125
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 93120
VA San Diego
San Diego, California, 92161
North Central Heart Hospital
Sioux Falls, South Dakota, 57108
Lake Health
Willoughby, Ohio, 44094
About this study
Official title: Prospective, Multicenter, Randomized Controlled Trial of Endovascular Aneurysm Repair Using a Bilateral Percutaneous Approach (PEVAR) vs. Standard Approach (SEVAR) Using the IntuiTrak Endovascular AAA Delivery System and the Prostar XL or Perclose ProGlide Suture-Mediated Closure System
To determine the safety and effectiveness of PEVAR.
Read the detailed description
In >30 single center publications, percutaneous EVAR facilitated with the Prostar XL or ProGlide closure has been demonstrated to be feasible. To date, no multicenter, randomized controlled trials of the approach are available. Moreover, although the IntuiTrak System and the closure devices are commercially available in the US as FDA-approved devices, no EVAR device and no closure device is FDA approved for a totally percutaneous EVAR application.
The IntuiTrak System is indicated for the treatment of abdominal aortic aneurysms with aortic necks ranging in size from 18mm to 32mm. The System includes a 19Fr integrated introducer sheath, which is designed to reduce exchanges, and may be particularly important in a percutaneous approach. Moreover, the device is the only currently approved EVAR device with a contralateral percutaneous (9Fr) indication.
Patients with abdominal aortic aneurysm who are suitable candidates for endovascular repair using the IntuiTrak System and who meet the prospectively defined inclusion/exclusion criteria specific to the trial will be randomized to PEVAR or to standard EVAR using vascular exposure access in a ratio of 2:1. Physicians who are established experts in the field of percutaneous EVAR will participate in the trial.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- PEVAR (ProGlide closure), SEVAR (IntuiTrak), PEVAR (Prostar XL closure)
- Keywords
- Percutaneous, Preclose, Endologix, Abbott Vascular, Endovascular, PEVAR, Stent graft, Suture mediated closure devices
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEVAR (ProGlide closure)Device
Also called IntuiTrak, ProGlide
Percutaneous EVAR facilitated by the ProGlide closure device
SEVAR (IntuiTrak)Device
Also called IntuiTrak
Standard vascular exposure for access prior to EVAR
PEVAR (Prostar XL closure)Device
Also called IntuiTrak, Prostar XL
Percutaneous EVAR facilitated by the Prostar XL closure device
| Study group | Role | What they receive |
|---|---|---|
| Standard EVAR (IntuiTrak) | Active comparator | EVAR using standard vascular exposure for access Receives: Device: SEVAR (IntuiTrak) |
| PEVAR (ProGlide closure) | Experimental | Percutaneous EVAR facilitated by the ProGlide closure device Receives: Device: PEVAR (ProGlide closure) |
| PEVAR (ProstarXL closure) | Experimental | Percutaneous EVAR facilitated by the Prostar XL closure device Receives: Device: PEVAR (Prostar XL closure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC).
The primary endpoint for the trial is 30-day Treatment Success, defined as the composite of the following as determined by the independent physician adjudicator:
- Procedural technical success
- Absence of vascular complication
- Absence of major adverse event
Measured: 30 days
Secondary outcomes (8)
Number of Participants With Serious Adverse Events
SAEs for Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).
Measured: 30 days
SF-36 (Health-related Quality of Life Survey)
Health-related Quality of Life per the standardized short form 36-item survey [SF-36]); self-reported groin pain per a Pain Scale.
It comprises 36 questions which cover eight domains of health:
- Physical Function (Range 0 to 100)
- Social Functioning (Range 0 to 100)
- Role Limitations due to physical Health (Range o to 100)
- Pain (Range 0 to 100)
- Mental Health (Range 0 to 100)
- Role limitations due to emotional health (Range 0 to 100)
- Energy and fatigue (Range 0 to 100)
- General health (Range 0 to 100)
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 30 days
Clinical Utility Measures
In-hospital evaluations: Time in ICU; Time to ambulation; Time to normal diet; Times to possible and actual hospital discharge.
Measured: From Procedure to Discharge Visit
Clinical Utility Measures
% requiring Foley catheter, central venous catheter, or gastric tube; % discharged to skilled nursing facility (SNFs) or assistive living facility (ALFs); % requiring analgesic for groin pain.
Measured: From Procedure to Discharge Visit
Number of Participants With All Non-serious Adverse Events
Adverse Events: Number of Participants with All non-serious adverse events in the three arms listed below.
Measured: 30 Days
Clinical Utility Measure
In-hospital evaluations: Contrast media volume used
Measured: Through Pre-Discharge Visit
Clinical Utility Measures
In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis.
Measured: During Procedure
Clinical Utility Measures
In-hospital evaluations: Times to possible and actual hospital discharge.
Measured: Through Pre-Discharge Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study start13 Apr 2010
- Primary completion9 Mar 2012
- Study completion5 Sep 2012
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Edward B Diethrich, MD, Principal investigator, Endologix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070069
- Sponsor's protocol ID
- CP-0001
- Acronym
- PEVAR
- Status last verified
- Mar 2022
- First submitted
- 16 Feb 2010
- Last updated
- 7 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wang Q, Wu J, Ma Y, Zhu Y, Song X, Xie S, Liang F, Gimzewska M, Li M, Yao L. Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair. Cochrane Database Syst Rev. 2023 Jan 11;1(1):CD010185. doi: 10.1002/14651858.CD010185.pub4.
PubMed 36629152Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1181-93. doi: 10.1016/j.jvs.2013.10.101. Epub 2014 Jan 17.
PubMed 24440678Krajcer Z, Nelson P, Bianchi C, Rao V, Morasch M, Bacharach J. Percutaneous endovascular abdominal aortic aneurysm repair: methods and initial outcomes from the first prospective, multicenter trial. J Cardiovasc Surg (Torino). 2011 Oct;52(5):651-9. Epub 2011 Jul 28.
PubMed 21796092
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Trial of Endovascular Aneurysm Repair Using a Bilateral Percutaneous Approach (PEVAR) vs. Standard Approach (SEVAR) Using the IntuiTrak Endovascular AAA Delivery System and the Prostar XL or Perclose ProGlide Suture-Mediated Closure System
- ClinicalTrials.gov ID
- NCT01070069
- Acronym / sponsor ID
- PEVAR / CP-0001
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Percutaneous, Preclose, Endologix, Abbott Vascular, Endovascular, PEVAR, Stent graft, Suture mediated closure devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Study start
- 13 Apr 2010 (actual)
- Primary completion
- 9 Mar 2012 (actual)
- Study completion
- 5 Sep 2012 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 7 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and effectiveness of PEVAR.
Detailed description
In >30 single center publications, percutaneous EVAR facilitated with the Prostar XL or ProGlide closure has been demonstrated to be feasible. To date, no multicenter, randomized controlled trials of the approach are available. Moreover, although the IntuiTrak System and the closure devices are commercially available in the US as FDA-approved devices, no EVAR device and no closure device is FDA approved for a totally percutaneous EVAR application.
The IntuiTrak System is indicated for the treatment of abdominal aortic aneurysms with aortic necks ranging in size from 18mm to 32mm. The System includes a 19Fr integrated introducer sheath, which is designed to reduce exchanges, and may be particularly important in a percutaneous approach. Moreover, the device is the only currently approved EVAR device with a contralateral percutaneous (9Fr) indication.
Patients with abdominal aortic aneurysm who are suitable candidates for endovascular repair using the IntuiTrak System and who meet the prospectively defined inclusion/exclusion criteria specific to the trial will be randomized to PEVAR or to standard EVAR using vascular exposure access in a ratio of 2:1. Physicians who are established experts in the field of percutaneous EVAR will participate in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard EVAR (IntuiTrak) | Active comparator | Device: SEVAR (IntuiTrak)EVAR using standard vascular exposure for access |
| PEVAR (ProGlide closure) | Experimental | Device: PEVAR (ProGlide closure)Percutaneous EVAR facilitated by the ProGlide closure device |
| PEVAR (ProstarXL closure) | Experimental | Device: PEVAR (Prostar XL closure)Percutaneous EVAR facilitated by the Prostar XL closure device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 18 years old
- Informed consent form understood and signed and patient agrees to all follow-up visits
- Abdominal aortic aneurysm (AAA) with maximum diameter ≥5cm, or in the range of 4 to 5cm which has increased by 0.5cm or more in the past six months
- Have a suitable ipsilateral common femoral artery for percutaneous access using a 'Pre-close' technique as detailed in the protocol
- Anatomically eligible for the IntuiTrak System per the FDA-approved indications for use (IFU)
Key exclusion criteria (23 listed)
- Life expectancy <1 year as judged by the investigator;
- Psychiatric or other condition that may interfere with the study;
- Participating in the enrollment or 30-day follow-up phase of another clinical study;
- Known allergy to any device component;
- Coagulopathy or uncontrolled bleeding disorder;
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 |
|---|---|---|
| PEVAR (ProGlide closure)Also: IntuiTrak, ProGlidePercutaneous EVAR facilitated by the ProGlide closure device | Device | PEVAR (ProGlide closure) |
| SEVAR (IntuiTrak)Also: IntuiTrakStandard vascular exposure for access prior to EVAR | Device | Standard EVAR (IntuiTrak) |
| PEVAR (Prostar XL closure)Also: IntuiTrak, Prostar XLPercutaneous EVAR facilitated by the Prostar XL closure device | Device | PEVAR (ProstarXL closure) |
Primary outcome
Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC).
Time frame: 30 days
The primary endpoint for the trial is 30-day Treatment Success, defined as the composite of the following as determined by the independent physician adjudicator: * Procedural technical success * Absence of vascular complication * Absence of major adverse event
8 secondary outcomes
Number of Participants With Serious Adverse Events
Time frame: 30 days
SF-36 (Health-related Quality of Life Survey)
Time frame: 30 days
Clinical Utility Measures
Time frame: From Procedure to Discharge Visit
Clinical Utility Measures
Time frame: From Procedure to Discharge Visit
Number of Participants With All Non-serious Adverse Events
Time frame: 30 Days
Clinical Utility Measure
Time frame: Through Pre-Discharge Visit
Clinical Utility Measures
Time frame: During Procedure
Clinical Utility Measures
Time frame: Through Pre-Discharge Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36629152Wang Q, Wu J, Ma Y, Zhu Y, Song X, Xie S, Liang F, Gimzewska M, Li M, Yao L. Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair. Cochrane Database Syst Rev. 2023 Jan 11;1(1):CD010185. doi: 10.1002/14651858.CD010185.pub4.
- Derived from this study: PubMed 24440678Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1181-93. doi: 10.1016/j.jvs.2013.10.101. Epub 2014 Jan 17.
- Derived from this study: PubMed 21796092Krajcer Z, Nelson P, Bianchi C, Rao V, Morasch M, Bacharach J. Percutaneous endovascular abdominal aortic aneurysm repair: methods and initial outcomes from the first prospective, multicenter trial. J Cardiovasc Surg (Torino). 2011 Oct;52(5):651-9. Epub 2011 Jul 28.
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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.
Edward B Diethrich, MD principal investigator
Endologix
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEVAR (ProGlide closure), SEVAR (IntuiTrak) and PEVAR (Prostar XL closure) in people with Abdominal Aortic Aneurysm, run by Endologix at 20 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 5 inclusion and 23 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 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 7 Jun 2022). 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?
Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC). (time frame: 30 days). 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 NCT01070069, which also lists 3 linked publications.
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 7 Jun 2022.