Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial

Abdominal Aortic Aneurysm Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070069
• Other study ID #: CP-0001
• Status: Completed
• Phase: N/A
• Start date: April 13, 2010
• Est. completion date: September 5, 2012

Study information

• Verified date: March 2022
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the safety and effectiveness of PEVAR.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 5, 2012
• Est. primary completion date: March 9, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• PEVAR (ProGlide closure)
Percutaneous EVAR facilitated by the ProGlide closure device
• SEVAR (IntuiTrak)
Standard vascular exposure for access prior to EVAR
• PEVAR (Prostar XL closure)
Percutaneous EVAR facilitated by the Prostar XL closure device

Locations

Country	Name	City	State
United States	Mission Hospital	Asheville	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Mercy Hospital	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Dallas VA Medical Center	Dallas	Texas
United States	Inova Fairfax	Falls Church	Virginia
United States	Holy Cross Medical Center	Fort Lauderdale	Florida
United States	VA Gainesville	Gainesville	Florida
United States	Forrest General Hospital	Hattiesburg	Mississippi
United States	St. Luke's Hospital at Texas Heart Institute	Houston	Texas
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Loma Linda VA Medical Center	Loma Linda	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	VA Miami	Miami	Florida
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	VA San Diego	San Diego	California
United States	North Central Heart Hospital	Sioux Falls	South Dakota
United States	Lake Health	Willoughby	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Endologix	Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	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).	30 days
Secondary	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.	30 days
Secondary	Clinical Utility Measures	In-hospital evaluations: Time in ICU; Time to ambulation; Time to normal diet; Times to possible and actual hospital discharge.	From Procedure to Discharge Visit
Secondary	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.	From Procedure to Discharge Visit
Secondary	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.	30 Days
Secondary	Clinical Utility Measure	In-hospital evaluations: Contrast media volume used	Through Pre-Discharge Visit
Secondary	Clinical Utility Measures	In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis.	During Procedure
Secondary	Clinical Utility Measures	In-hospital evaluations: Times to possible and actual hospital discharge.	Through Pre-Discharge Visit