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Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial (PEVAR)

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEVAR (ProGlide closure)
SEVAR (IntuiTrak)
PEVAR (Prostar XL closure)
Sponsored by
Endologix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Percutaneous, Preclose, Endologix, Abbott Vascular, Endovascular, PEVAR, Stent graft, Suture mediated closure devices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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;
  • 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

Sites / Locations

  • Loma Linda VA Medical Center
  • VA San Diego
  • Holy Cross Medical Center
  • VA Gainesville
  • VA Miami
  • Baptist Cardiac and Vascular Institute
  • Northwestern University
  • Mercy Hospital
  • Forrest General Hospital
  • Dartmouth-Hitchcock Medical Center
  • Mission Hospital
  • Cleveland Clinic
  • Lake Health
  • Oklahoma Heart Hospital
  • North Central Heart Hospital
  • Dallas VA Medical Center
  • St. Luke's Hospital at Texas Heart Institute
  • University of Virginia
  • Inova Fairfax
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard EVAR (IntuiTrak)

PEVAR (ProGlide closure)

PEVAR (ProstarXL closure)

Arm Description

EVAR using standard vascular exposure for access

Percutaneous EVAR facilitated by the ProGlide closure device

Percutaneous EVAR facilitated by the Prostar XL closure device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.
Clinical Utility Measures
In-hospital evaluations: Time in ICU; Time to ambulation; Time to normal diet; Times to possible and actual hospital discharge.
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.
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.
Clinical Utility Measure
In-hospital evaluations: Contrast media volume used
Clinical Utility Measures
In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis.
Clinical Utility Measures
In-hospital evaluations: Times to possible and actual hospital discharge.

Full Information

First Posted
February 16, 2010
Last Updated
June 6, 2022
Sponsor
Endologix
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01070069
Brief Title
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
Acronym
PEVAR
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2010 (Actual)
Primary Completion Date
March 9, 2012 (Actual)
Study Completion Date
September 5, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endologix
Collaborators
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
Percutaneous, Preclose, Endologix, Abbott Vascular, Endovascular, PEVAR, Stent graft, Suture mediated closure devices

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard EVAR (IntuiTrak)
Arm Type
Active Comparator
Arm Description
EVAR using standard vascular exposure for access
Arm Title
PEVAR (ProGlide closure)
Arm Type
Experimental
Arm Description
Percutaneous EVAR facilitated by the ProGlide closure device
Arm Title
PEVAR (ProstarXL closure)
Arm Type
Experimental
Arm Description
Percutaneous EVAR facilitated by the Prostar XL closure device
Intervention Type
Device
Intervention Name(s)
PEVAR (ProGlide closure)
Other Intervention Name(s)
IntuiTrak, ProGlide
Intervention Description
Percutaneous EVAR facilitated by the ProGlide closure device
Intervention Type
Device
Intervention Name(s)
SEVAR (IntuiTrak)
Other Intervention Name(s)
IntuiTrak
Intervention Description
Standard vascular exposure for access prior to EVAR
Intervention Type
Device
Intervention Name(s)
PEVAR (Prostar XL closure)
Other Intervention Name(s)
IntuiTrak, Prostar XL
Intervention Description
Percutaneous EVAR facilitated by the Prostar XL closure device
Primary Outcome Measure Information:
Title
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).
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events
Description
SAEs for Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).
Time Frame
30 days
Title
SF-36 (Health-related Quality of Life Survey)
Description
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.
Time Frame
30 days
Title
Clinical Utility Measures
Description
In-hospital evaluations: Time in ICU; Time to ambulation; Time to normal diet; Times to possible and actual hospital discharge.
Time Frame
From Procedure to Discharge Visit
Title
Clinical Utility Measures
Description
% 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.
Time Frame
From Procedure to Discharge Visit
Title
Number of Participants With All Non-serious Adverse Events
Description
Adverse Events: Number of Participants with All non-serious adverse events in the three arms listed below.
Time Frame
30 Days
Title
Clinical Utility Measure
Description
In-hospital evaluations: Contrast media volume used
Time Frame
Through Pre-Discharge Visit
Title
Clinical Utility Measures
Description
In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis.
Time Frame
During Procedure
Title
Clinical Utility Measures
Description
In-hospital evaluations: Times to possible and actual hospital discharge.
Time Frame
Through Pre-Discharge Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward B Diethrich, MD
Organizational Affiliation
Endologix
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda VA Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
VA San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Holy Cross Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
VA Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
VA Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Baptist Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Mercy Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Forrest General Hospital
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Lake Health
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
93120
Country
United States
Facility Name
North Central Heart Hospital
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
St. Luke's Hospital at Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Inova Fairfax
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24440678
Citation
Nelson 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.
Results Reference
derived
PubMed Identifier
21796092
Citation
Krajcer 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.
Results Reference
derived

Learn more about this trial

Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial

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