Abdominal Aortic Aneurysm
Conditions
Keywords
Percutaneous, Preclose, Endologix, Abbott Vascular, Endovascular, PEVAR, Stent graft, Suture mediated closure devices
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.
Interventions
DEVICEPEVAR (ProGlide closure)
Percutaneous EVAR facilitated by the ProGlide closure device
DEVICESEVAR (IntuiTrak)
Standard vascular exposure for access prior to EVAR
DEVICEPEVAR (Prostar XL closure)
Percutaneous EVAR facilitated by the Prostar XL closure device
Sponsors
Abbott Medical Devices
Endologix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events | 30 days | 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) | 30 days | 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: 1. Physical Function (Range 0 to 100) 2. Social Functioning (Range 0 to 100) 3. Role Limitations due to physical Health (Range o to 100) 4. Pain (Range 0 to 100) 5. Mental Health (Range 0 to 100) 6. Role limitations due to emotional health (Range 0 to 100) 7. Energy and fatigue (Range 0 to 100) 8. 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 | From Procedure to Discharge Visit | In-hospital evaluations: Time in ICU; Time to ambulation; Time to normal diet; Times to possible and actual hospital discharge. |
| Number of Participants With All Non-serious Adverse Events | 30 Days | Adverse Events: Number of Participants with All non-serious adverse events in the three arms listed below. |
| Clinical Utility Measure | Through Pre-Discharge Visit | In-hospital evaluations: Contrast media volume used |
Countries
United States
Participant flow
Recruitment details
41 Roll-in patients were entered in the study. 151 patients were randomized to either PEVAR ProGlide, PEVAR Prostar XL or SEVAR treatment for AAA repair. The enrollment period was from July 15, 2010 to February 9, 2012. The final patient completed the study in September 2012.
Pre-assignment details
151 Randomized patients and 41 Roll-in patients were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| SEVAR Standard vascular exposure cutdown approach (SEVAR=Control). | 50 |
| PEVAR Perclose ProGlide PEVAR performed with the Perclose ProGlide suture mediated closure system. | 50 |
| PEVAR Prostar XL PEVAR performed with the Prostar XL suture mediated closure system. | 51 |
| PEVAR (Prostar XL Roll -In) PEVAR performed with the Prostar XL suture mediated closure system. | 19 |
| PEVAR (ProGlide Roll -In) PEVAR performed with the Prostar XL suture mediated closure system. | 22 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 1 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | SEVAR | PEVAR Perclose ProGlide | PEVAR Prostar XL | PEVAR (Prostar XL Roll -In) | PEVAR (ProGlide Roll -In) |
|---|---|---|---|---|---|---|
| Age, Continuous | 72.2 years STANDARD_DEVIATION 7.98 | 73 years STANDARD_DEVIATION 8.8 | 70 years STANDARD_DEVIATION 6.6 | 74 years STANDARD_DEVIATION 10.6 | 73 years STANDARD_DEVIATION 7 | 71 years STANDARD_DEVIATION 6.9 |
| BMI | 28.2 Kg/m^2 STANDARD_DEVIATION 4.7 | 28 Kg/m^2 STANDARD_DEVIATION 4.7 | 29 Kg/m^2 STANDARD_DEVIATION 3.9 | 28 Kg/m^2 STANDARD_DEVIATION 4.7 | 27 Kg/m^2 STANDARD_DEVIATION 4.4 | 29 Kg/m^2 STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized Non-white | 20 participants | 3 participants | 4 participants | 7 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized White | 172 participants | 47 participants | 46 participants | 44 participants | 15 participants | 20 participants |
| Region of Enrollment United States | 151 participants | 50 participants | 50 participants | 51 participants | 19 participants | 22 participants |
| Sex: Female, Male Female | 17 Participants | 5 Participants | 3 Participants | 7 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 175 Participants | 45 Participants | 47 Participants | 44 Participants | 18 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 42 / 50 | 44 / 50 | 39 / 51 | 14 / 19 | 20 / 22 |
| serious Total, serious adverse events | 20 / 50 | 13 / 50 | 19 / 51 | 9 / 19 | 6 / 22 |
Outcome results
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
Time frame: 30 days
Population: PEVAR (Prostar XL Roll-in) and PEVAR (ProGlide Roll-in) were not part of the primary endpoint analysis cohort and hence not included in this section.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard EVAR (IntuiTrak) | 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). | Subjects with Treatment Success | 39 Participants |
| Standard EVAR (IntuiTrak) | 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). | Subjects with unsuccessful Treatment | 11 Participants |
| PEVAR (ProGlide Closure) | 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). | Subjects with Treatment Success | 44 Participants |
| PEVAR (ProGlide Closure) | 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). | Subjects with unsuccessful Treatment | 6 Participants |
| PEVAR (ProstarXL Closure) | 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). | Subjects with Treatment Success | 40 Participants |
| PEVAR (ProstarXL Closure) | 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). | Subjects with unsuccessful Treatment | 11 Participants |
Secondary
Clinical Utility Measure
In-hospital evaluations: Contrast media volume used
Time frame: Through Pre-Discharge Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard EVAR (IntuiTrak) | Clinical Utility Measure | 144 mL | Standard Deviation 90 |
| PEVAR (ProGlide Closure) | Clinical Utility Measure | 120 mL | Standard Deviation 78 |
| PEVAR (ProstarXL Closure) | Clinical Utility Measure | 123 mL | Standard Deviation 56 |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measure | 157 mL | Standard Deviation 94 |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measure | 118 mL | Standard Deviation 54 |
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.
Time frame: From Procedure to Discharge Visit
Population: All available data has been reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Foley Catheter | 82 percentage of participants |
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Central Venous Catheter | 20 percentage of participants |
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Nasogastric Tube | 6.0 percentage of participants |
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Discharged to SNF/ALF | 2.0 percentage of participants |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Foley Catheter | 80 percentage of participants |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Discharged to SNF/ALF | 0 percentage of participants |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Central Venous Catheter | 38 percentage of participants |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Nasogastric Tube | 14 percentage of participants |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Discharged to SNF/ALF | 0 percentage of participants |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Central Venous Catheter | 38 percentage of participants |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Nasogastric Tube | 2.0 percentage of participants |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Foley Catheter | 80 percentage of participants |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Foley Catheter | 96 percentage of participants |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Central Venous Catheter | 18 percentage of participants |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Discharged to SNF/ALF | 4.5 percentage of participants |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Nasogastric Tube | 14 percentage of participants |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Discharged to SNF/ALF | 0 percentage of participants |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Nasogastric Tube | 0 percentage of participants |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Central Venous Catheter | 11 percentage of participants |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Foley Catheter | 89 percentage of participants |
Secondary
Clinical Utility Measures
In-hospital evaluations: Times to possible and actual hospital discharge.
Time frame: Through Pre-Discharge Visit
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | EligibleTime to Hospital Discharge, days | 1.76 Days | Standard Deviation 2.47 |
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Actual Time to Hospital Discharge, days | 1.8 Days | Standard Deviation 2.4 |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | EligibleTime to Hospital Discharge, days | 1.2 Days | Standard Deviation 0.7 |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Actual Time to Hospital Discharge, days | 1.3 Days | Standard Deviation 0.7 |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | EligibleTime to Hospital Discharge, days | 1.29 Days | Standard Deviation 0.83 |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Actual Time to Hospital Discharge, days | 1.4 Days | Standard Deviation 0.9 |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Actual Time to Hospital Discharge, days | 1.4 Days | Standard Deviation 0.5 |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | EligibleTime to Hospital Discharge, days | 1.3 Days | Standard Deviation 0.5 |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | EligibleTime to Hospital Discharge, days | 1.4 Days | Standard Deviation 1 |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Actual Time to Hospital Discharge, days | 2.1 Days | Standard Deviation 0 |
Secondary
Clinical Utility Measures
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
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | ICU Length of Stay, hours | 35 Hours | Standard Deviation 38 |
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Time to Normal Diet, hours | 15 Hours | Standard Deviation 22 |
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Time to Ambulation, hours | 19 Hours | Standard Deviation 16 |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Time to Ambulation, hours | 17 Hours | Standard Deviation 7.2 |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | ICU Length of Stay, hours | 26 Hours | Standard Deviation 9 |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Time to Normal Diet, hours | 14 Hours | Standard Deviation 9.4 |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Time to Ambulation, hours | 16 Hours | Standard Deviation 9.1 |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | ICU Length of Stay, hours | 31 Hours | Standard Deviation 15 |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Time to Normal Diet, hours | 10 Hours | Standard Deviation 8.4 |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | ICU Length of Stay, hours | 33 Hours | Standard Deviation 11 |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Time to Normal Diet, hours | 17 Hours | Standard Deviation 7.4 |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Time to Ambulation, hours | 22 Hours | Standard Deviation 13 |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Time to Ambulation, hours | 19 Hours | Standard Deviation 14 |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | ICU Length of Stay, hours | 12 Hours | Standard Deviation 25 |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Time to Normal Diet, hours | 18 Hours | Standard Deviation 11 |
Secondary
Clinical Utility Measures
In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis.
Time frame: During Procedure
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Anesthesia Time, min | 203 Min | Standard Deviation 93 |
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Ipsilateral Time to Hemostasis, min | 23 Min | Standard Deviation 23 |
| Standard EVAR (IntuiTrak) | Clinical Utility Measures | Fluoroscopy Time, min | 24 Min | Standard Deviation 14 |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Fluoroscopy Time, min | 26 Min | Standard Deviation 16 |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Anesthesia Time, min | 181 Min | Standard Deviation 65 |
| PEVAR (ProGlide Closure) | Clinical Utility Measures | Ipsilateral Time to Hemostasis, min | 9.8 Min | Standard Deviation 17 |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Fluoroscopy Time, min | 22 Min | Standard Deviation 8.5 |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Anesthesia Time, min | 152 Min | Standard Deviation 56 |
| PEVAR (ProstarXL Closure) | Clinical Utility Measures | Ipsilateral Time to Hemostasis, min | 13 Min | Standard Deviation 19 |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Anesthesia Time, min | 201 Min | Standard Deviation 75 |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Ipsilateral Time to Hemostasis, min | 7.7 Min | Standard Deviation 6.8 |
| PEVAR (ProGlide Roll-in) | Clinical Utility Measures | Fluoroscopy Time, min | 30 Min | Standard Deviation 16 |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Fluoroscopy Time, min | 25 Min | Standard Deviation 13 |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Anesthesia Time, min | 2.9 Min | Standard Deviation 1.28 |
| PEVAR (ProStar XL Roll-in) | Clinical Utility Measures | Ipsilateral Time to Hemostasis, min | 5.6 Min | Standard Deviation 6.1 |
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.
Time frame: 30 Days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Musculoskeletal and connective tissue disorders | 2 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Metabolism and nutrition disorders | 3 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Injury, poisoning and procedural complications | 10 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Cardiac disorders | 0 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Investigations | 16 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Gastrointestinal disorders | 6 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Reproductive system and breast disorders | 0 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Vascular disorders | 7 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Surgical and medical procedures | 2 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Skin and subcutaneous tissue disorders | 2 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | General disorders and administration site conditions | 19 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Blood and lymphatic system disorders | 3 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 2 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Renal and urinary disorders | 3 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Psychiatric disorders | 2 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Infections and infestations | 4 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Congenital, familial and genetic disorders | 0 Number of participants |
| Standard EVAR (IntuiTrak) | Number of Participants With All Non-serious Adverse Events | Nervous system disorders | 2 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | General disorders and administration site conditions | 12 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Blood and lymphatic system disorders | 1 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Gastrointestinal disorders | 9 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Infections and infestations | 4 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Injury, poisoning and procedural complications | 13 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Investigations | 23 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Metabolism and nutrition disorders | 14 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Musculoskeletal and connective tissue disorders | 0 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Nervous system disorders | 4 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Psychiatric disorders | 1 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Renal and urinary disorders | 3 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 3 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Skin and subcutaneous tissue disorders | 2 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Surgical and medical procedures | 2 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Vascular disorders | 4 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Cardiac disorders | 1 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Congenital, familial and genetic disorders | 0 Number of participants |
| PEVAR (ProGlide Closure) | Number of Participants With All Non-serious Adverse Events | Reproductive system and breast disorders | 0 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Reproductive system and breast disorders | 1 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | General disorders and administration site conditions | 10 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Investigations | 19 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 2 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Cardiac disorders | 2 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Vascular disorders | 1 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Gastrointestinal disorders | 4 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Surgical and medical procedures | 3 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Skin and subcutaneous tissue disorders | 0 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Infections and infestations | 2 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Blood and lymphatic system disorders | 3 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Psychiatric disorders | 0 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Musculoskeletal and connective tissue disorders | 3 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Injury, poisoning and procedural complications | 10 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Nervous system disorders | 2 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Congenital, familial and genetic disorders | 1 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Renal and urinary disorders | 0 Number of participants |
| PEVAR (ProstarXL Closure) | Number of Participants With All Non-serious Adverse Events | Metabolism and nutrition disorders | 2 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Injury, poisoning and procedural complications | 4 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Musculoskeletal and connective tissue disorders | 1 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Blood and lymphatic system disorders | 4 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Nervous system disorders | 1 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Reproductive system and breast disorders | 0 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Psychiatric disorders | 1 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | General disorders and administration site conditions | 13 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Renal and urinary disorders | 0 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Congenital, familial and genetic disorders | 0 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 0 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Skin and subcutaneous tissue disorders | 1 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Gastrointestinal disorders | 2 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Surgical and medical procedures | 0 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Vascular disorders | 1 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Investigations | 11 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Cardiac disorders | 1 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Metabolism and nutrition disorders | 3 Number of participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With All Non-serious Adverse Events | Infections and infestations | 1 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 1 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Metabolism and nutrition disorders | 2 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Vascular disorders | 1 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Blood and lymphatic system disorders | 2 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Renal and urinary disorders | 4 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Cardiac disorders | 0 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Injury, poisoning and procedural complications | 5 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Psychiatric disorders | 0 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | General disorders and administration site conditions | 9 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Nervous system disorders | 1 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Musculoskeletal and connective tissue disorders | 2 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Investigations | 5 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Skin and subcutaneous tissue disorders | 0 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Congenital, familial and genetic disorders | 0 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Infections and infestations | 0 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Surgical and medical procedures | 0 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Gastrointestinal disorders | 5 Number of participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With All Non-serious Adverse Events | Reproductive system and breast disorders | 1 Number of participants |
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).
Time frame: 30 days
Population: SAEs Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 2 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Patients with at least 1 SAE | 13 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Cardiac disorders | 0 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Vascular disorders | 4 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | General disorders and administration site conditions | 1 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Blood and lymphatic system disorders | 3 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Surgical and medical procedures | 0 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Metabolism and nutrition disorders | 0 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Investigations | 4 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Injury, poisoning and procedural complications | 0 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Infections and infestations | 0 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Nervous system disorders | 3 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Renal and urinary disorders | 2 participants |
| Standard EVAR (IntuiTrak) | Number of Participants With Serious Adverse Events | Gastrointestinal disorders | 1 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Investigations | 3 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Renal and urinary disorders | 2 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 0 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Injury, poisoning and procedural complications | 0 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Blood and lymphatic system disorders | 1 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Cardiac disorders | 0 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Gastrointestinal disorders | 0 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Metabolism and nutrition disorders | 1 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | General disorders and administration site conditions | 1 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Patients with at least 1 SAE | 5 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Surgical and medical procedures | 0 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Infections and infestations | 1 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Nervous system disorders | 0 participants |
| PEVAR (ProGlide Closure) | Number of Participants With Serious Adverse Events | Vascular disorders | 0 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Nervous system disorders | 1 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Patients with at least 1 SAE | 16 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Blood and lymphatic system disorders | 1 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Gastrointestinal disorders | 1 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | General disorders and administration site conditions | 3 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Investigations | 2 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Renal and urinary disorders | 4 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 2 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Vascular disorders | 4 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Infections and infestations | 3 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Metabolism and nutrition disorders | 1 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Cardiac disorders | 2 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Injury, poisoning and procedural complications | 1 participants |
| PEVAR (ProstarXL Closure) | Number of Participants With Serious Adverse Events | Surgical and medical procedures | 1 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Vascular disorders | 2 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | General disorders and administration site conditions | 2 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Cardiac disorders | 1 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Investigations | 0 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Blood and lymphatic system disorders | 1 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Patients with at least 1 SAE | 6 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Surgical and medical procedures | 0 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Metabolism and nutrition disorders | 1 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Renal and urinary disorders | 0 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Injury, poisoning and procedural complications | 0 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 1 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Infections and infestations | 0 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Gastrointestinal disorders | 1 participants |
| PEVAR (ProGlide Roll-in) | Number of Participants With Serious Adverse Events | Nervous system disorders | 0 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Blood and lymphatic system disorders | 2 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Vascular disorders | 4 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Investigations | 0 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Infections and infestations | 0 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Gastrointestinal disorders | 0 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | General disorders and administration site conditions | 2 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Metabolism and nutrition disorders | 1 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Injury, poisoning and procedural complications | 3 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Surgical and medical procedures | 0 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Cardiac disorders | 0 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Patients with at least 1 SAE | 9 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Renal and urinary disorders | 0 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Respiratory, thoracic and mediastinal disorders | 1 participants |
| PEVAR (ProStar XL Roll-in) | Number of Participants With Serious Adverse Events | Nervous system disorders | 0 participants |
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: 1. Physical Function (Range 0 to 100) 2. Social Functioning (Range 0 to 100) 3. Role Limitations due to physical Health (Range o to 100) 4. Pain (Range 0 to 100) 5. Mental Health (Range 0 to 100) 6. Role limitations due to emotional health (Range 0 to 100) 7. Energy and fatigue (Range 0 to 100) 8. 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
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard EVAR (IntuiTrak) | SF-36 (Health-related Quality of Life Survey) | Physical Function at 1 Month | 64 Scores on a Scale | Standard Deviation 27 |
| Standard EVAR (IntuiTrak) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Physical Health at 1 Month | 47 Scores on a Scale | Standard Deviation 46 |
| Standard EVAR (IntuiTrak) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Emotional Health at 1 Month | 72 Scores on a Scale | Standard Deviation 42 |
| Standard EVAR (IntuiTrak) | SF-36 (Health-related Quality of Life Survey) | Energy/Fatigue at 1 Month | 54 Scores on a Scale | Standard Deviation 24 |
| Standard EVAR (IntuiTrak) | SF-36 (Health-related Quality of Life Survey) | Mental Health at 1 Month | 79 Scores on a Scale | Standard Deviation 19 |
| Standard EVAR (IntuiTrak) | SF-36 (Health-related Quality of Life Survey) | Social Functioning at 1 Month | 52 Scores on a Scale | Standard Deviation 16 |
| Standard EVAR (IntuiTrak) | SF-36 (Health-related Quality of Life Survey) | Pain at 1 Month | 74 Scores on a Scale | Standard Deviation 23 |
| Standard EVAR (IntuiTrak) | SF-36 (Health-related Quality of Life Survey) | General Health at 1 Month | 46 Scores on a Scale | Standard Deviation 16 |
| PEVAR (ProGlide Closure) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Emotional Health at 1 Month | 68 Scores on a Scale | Standard Deviation 40 |
| PEVAR (ProGlide Closure) | SF-36 (Health-related Quality of Life Survey) | Social Functioning at 1 Month | 55 Scores on a Scale | Standard Deviation 17 |
| PEVAR (ProGlide Closure) | SF-36 (Health-related Quality of Life Survey) | Physical Function at 1 Month | 71 Scores on a Scale | Standard Deviation 27 |
| PEVAR (ProGlide Closure) | SF-36 (Health-related Quality of Life Survey) | Energy/Fatigue at 1 Month | 55 Scores on a Scale | Standard Deviation 25 |
| PEVAR (ProGlide Closure) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Physical Health at 1 Month | 59 Scores on a Scale | Standard Deviation 40 |
| PEVAR (ProGlide Closure) | SF-36 (Health-related Quality of Life Survey) | General Health at 1 Month | 48 Scores on a Scale | Standard Deviation 14 |
| PEVAR (ProGlide Closure) | SF-36 (Health-related Quality of Life Survey) | Mental Health at 1 Month | 73 Scores on a Scale | Standard Deviation 20 |
| PEVAR (ProGlide Closure) | SF-36 (Health-related Quality of Life Survey) | Pain at 1 Month | 69 Scores on a Scale | Standard Deviation 27 |
| PEVAR (ProstarXL Closure) | SF-36 (Health-related Quality of Life Survey) | Pain at 1 Month | 78 Scores on a Scale | Standard Deviation 26 |
| PEVAR (ProstarXL Closure) | SF-36 (Health-related Quality of Life Survey) | General Health at 1 Month | 48 Scores on a Scale | Standard Deviation 18 |
| PEVAR (ProstarXL Closure) | SF-36 (Health-related Quality of Life Survey) | Energy/Fatigue at 1 Month | 51 Scores on a Scale | Standard Deviation 21 |
| PEVAR (ProstarXL Closure) | SF-36 (Health-related Quality of Life Survey) | Social Functioning at 1 Month | 53 Scores on a Scale | Standard Deviation 20 |
| PEVAR (ProstarXL Closure) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Emotional Health at 1 Month | 78 Scores on a Scale | Standard Deviation 38 |
| PEVAR (ProstarXL Closure) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Physical Health at 1 Month | 51 Scores on a Scale | Standard Deviation 45 |
| PEVAR (ProstarXL Closure) | SF-36 (Health-related Quality of Life Survey) | Physical Function at 1 Month | 60 Scores on a Scale | Standard Deviation 26 |
| PEVAR (ProstarXL Closure) | SF-36 (Health-related Quality of Life Survey) | Mental Health at 1 Month | 82 Scores on a Scale | Standard Deviation 15 |
| PEVAR (ProGlide Roll-in) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Physical Health at 1 Month | 51 Scores on a Scale | Standard Deviation 44 |
| PEVAR (ProGlide Roll-in) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Emotional Health at 1 Month | 67 Scores on a Scale | Standard Deviation 44 |
| PEVAR (ProGlide Roll-in) | SF-36 (Health-related Quality of Life Survey) | Energy/Fatigue at 1 Month | 52 Scores on a Scale | Standard Deviation 25 |
| PEVAR (ProGlide Roll-in) | SF-36 (Health-related Quality of Life Survey) | Mental Health at 1 Month | 82 Scores on a Scale | Standard Deviation 17 |
| PEVAR (ProGlide Roll-in) | SF-36 (Health-related Quality of Life Survey) | Social Functioning at 1 Month | 78 Scores on a Scale | Standard Deviation 26 |
| PEVAR (ProGlide Roll-in) | SF-36 (Health-related Quality of Life Survey) | General Health at 1 Month | 65 Scores on a Scale | Standard Deviation 24 |
| PEVAR (ProGlide Roll-in) | SF-36 (Health-related Quality of Life Survey) | Physical Function at 1 Month | 58 Scores on a Scale | Standard Deviation 26 |
| PEVAR (ProGlide Roll-in) | SF-36 (Health-related Quality of Life Survey) | Pain at 1 Month | 73 Scores on a Scale | Standard Deviation 26 |
| PEVAR (ProStar XL Roll-in) | SF-36 (Health-related Quality of Life Survey) | Energy/Fatigue at 1 Month | 63 Scores on a Scale | Standard Deviation 20 |
| PEVAR (ProStar XL Roll-in) | SF-36 (Health-related Quality of Life Survey) | General Health at 1 Month | 77 Scores on a Scale | Standard Deviation 15 |
| PEVAR (ProStar XL Roll-in) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Emotional Health at 1 Month | 79 Scores on a Scale | Standard Deviation 34 |
| PEVAR (ProStar XL Roll-in) | SF-36 (Health-related Quality of Life Survey) | Pain at 1 Month | 80 Scores on a Scale | Standard Deviation 29 |
| PEVAR (ProStar XL Roll-in) | SF-36 (Health-related Quality of Life Survey) | Physical Function at 1 Month | 70 Scores on a Scale | Standard Deviation 21 |
| PEVAR (ProStar XL Roll-in) | SF-36 (Health-related Quality of Life Survey) | Social Functioning at 1 Month | 84 Scores on a Scale | Standard Deviation 25 |
| PEVAR (ProStar XL Roll-in) | SF-36 (Health-related Quality of Life Survey) | Role Limitations due to Physical Health at 1 Month | 43 Scores on a Scale | Standard Deviation 41 |
| PEVAR (ProStar XL Roll-in) | SF-36 (Health-related Quality of Life Survey) | Mental Health at 1 Month | 87 Scores on a Scale | Standard Deviation 19 |