Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial

Study Overview
=================
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.

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

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: PEVAR (ProGlide closure)
* Device: SEVAR (IntuiTrak)
* Device: PEVAR (Prostar XL closure)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard EVAR (IntuiTrak)<br>EVAR using standard vascular exposure for access | Device: SEVAR (IntuiTrak)<br>* Standard vascular exposure for access prior to EVAR<br>* Other names: IntuiTrak;|
| Experimental: PEVAR (ProGlide closure)<br>Percutaneous EVAR facilitated by the ProGlide closure device | Device: PEVAR (ProGlide closure)<br>* Percutaneous EVAR facilitated by the ProGlide closure device<br>* Other names: ProGlide;|
| Experimental: PEVAR (ProstarXL closure)<br>Percutaneous EVAR facilitated by the Prostar XL closure device | Device: PEVAR (Prostar XL closure)<br>* Percutaneous EVAR facilitated by the Prostar XL closure device<br>* Other names: Prostar XL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Clinical Utility Measure | In-hospital evaluations: Contrast media volume used | Through Pre-Discharge Visit | 
| Clinical Utility Measures | In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis. | During Procedure | 
| Clinical Utility Measures | In-hospital evaluations: Times to possible and actual hospital discharge. | Through Pre-Discharge Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous, Preclose, Endologix, Abbott Vascular, Endovascular, PEVAR, Stent graft, Suture mediated closure devices