Trial Outcomes & Findings for Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial (NCT NCT01070069)

Last Updated: 2022-06-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

192 participants

Primary outcome timeframe

30 days

Results posted on

2022-06-07

Participant Flow

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.

151 Randomized patients and 41 Roll-in patients were enrolled in the study.

Participant milestones

Participant milestones
Measure	Standard EVAR (IntuiTrak) EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (Prostar XL Roll-In Phase) Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-In Phase) Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
Overall Study STARTED	50	50	51	19	22
Overall Study COMPLETED	44	48	45	19	18
Overall Study NOT COMPLETED	6	2	6	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard EVAR (IntuiTrak) EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-In Phase) Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
Overall Study Death	1	0	2	1
Overall Study Withdrawal by Subject	1	1	4	0
Overall Study Lost to Follow-up	4	1	0	3

Baseline Characteristics

Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SEVAR n=50 Participants Standard vascular exposure cutdown approach (SEVAR=Control).	PEVAR Perclose ProGlide n=50 Participants PEVAR performed with the Perclose ProGlide suture mediated closure system.	PEVAR Prostar XL n=51 Participants PEVAR performed with the Prostar XL suture mediated closure system.	PEVAR (Prostar XL Roll -In) n=19 Participants PEVAR performed with the Prostar XL suture mediated closure system.	PEVAR (ProGlide Roll -In) n=22 Participants PEVAR performed with the Prostar XL suture mediated closure system.	Total n=192 Participants Total of all reporting groups
Age, Continuous	73 years STANDARD_DEVIATION 8.8 • n=5 Participants	70 years STANDARD_DEVIATION 6.6 • n=7 Participants	74 years STANDARD_DEVIATION 10.6 • n=5 Participants	73 years STANDARD_DEVIATION 7.0 • n=4 Participants	71 years STANDARD_DEVIATION 6.9 • n=21 Participants	72.2 years STANDARD_DEVIATION 7.98 • n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	17 Participants n=8 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	47 Participants n=7 Participants	44 Participants n=5 Participants	18 Participants n=4 Participants	21 Participants n=21 Participants	175 Participants n=8 Participants
Race/Ethnicity, Customized White	47 participants n=5 Participants	46 participants n=7 Participants	44 participants n=5 Participants	15 participants n=4 Participants	20 participants n=21 Participants	172 participants n=8 Participants
Race/Ethnicity, Customized Non-white	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants	4 participants n=4 Participants	2 participants n=21 Participants	20 participants n=8 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	51 participants n=5 Participants	19 participants n=4 Participants	22 participants n=21 Participants	151 participants n=8 Participants
BMI	28 Kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants	29 Kg/m^2 STANDARD_DEVIATION 3.9 • n=7 Participants	28 Kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants	27 Kg/m^2 STANDARD_DEVIATION 4.4 • n=4 Participants	29 Kg/m^2 STANDARD_DEVIATION 5.8 • n=21 Participants	28.2 Kg/m^2 STANDARD_DEVIATION 4.7 • n=8 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard EVAR (IntuiTrak) n=50 Participants EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 Participants Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 Participants Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-in) PEVAR performed with the ProGlide suture mediated closure system.	PEVAR (ProStar XL Roll-in) PEVAR performed with the ProStar XL suture mediated closure system.
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	44 Participants	40 Participants	—	—
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	6 Participants	11 Participants	—	—

SECONDARY outcome

Timeframe: 30 days

Population: SAEs Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).

SAEs for Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).

Outcome measures

Outcome measures
Measure	Standard EVAR (IntuiTrak) n=50 Participants EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 Participants Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 Participants Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-in) n=22 Participants PEVAR performed with the ProGlide suture mediated closure system.	PEVAR (ProStar XL Roll-in) n=19 Participants PEVAR performed with the ProStar XL suture mediated closure system.
Number of Participants With Serious Adverse Events Patients with at least 1 SAE	13 participants	5 participants	16 participants	6 participants	9 participants
Number of Participants With Serious Adverse Events Blood and lymphatic system disorders	3 participants	1 participants	1 participants	1 participants	2 participants
Number of Participants With Serious Adverse Events Gastrointestinal disorders	1 participants	0 participants	1 participants	1 participants	0 participants
Number of Participants With Serious Adverse Events General disorders and administration site conditions	1 participants	1 participants	3 participants	2 participants	2 participants
Number of Participants With Serious Adverse Events Investigations	4 participants	3 participants	2 participants	0 participants	0 participants
Number of Participants With Serious Adverse Events Nervous system disorders	3 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With Serious Adverse Events Renal and urinary disorders	2 participants	2 participants	4 participants	0 participants	0 participants
Number of Participants With Serious Adverse Events Respiratory, thoracic and mediastinal disorders	2 participants	0 participants	2 participants	1 participants	1 participants
Number of Participants With Serious Adverse Events Vascular disorders	4 participants	0 participants	4 participants	2 participants	4 participants
Number of Participants With Serious Adverse Events Infections and infestations	0 participants	1 participants	3 participants	0 participants	0 participants
Number of Participants With Serious Adverse Events Metabolism and nutrition disorders	0 participants	1 participants	1 participants	1 participants	1 participants
Number of Participants With Serious Adverse Events Cardiac disorders	0 participants	0 participants	2 participants	1 participants	0 participants
Number of Participants With Serious Adverse Events Injury, poisoning and procedural complications	0 participants	0 participants	1 participants	0 participants	3 participants
Number of Participants With Serious Adverse Events Surgical and medical procedures	0 participants	0 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 30 days

Population: All available data has been reported.

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.

Outcome measures

Outcome measures
Measure	Standard EVAR (IntuiTrak) n=50 Participants EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 Participants Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 Participants Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-in) n=22 Participants PEVAR performed with the ProGlide suture mediated closure system.	PEVAR (ProStar XL Roll-in) n=19 Participants PEVAR performed with the ProStar XL suture mediated closure system.
SF-36 (Health-related Quality of Life Survey) Physical Function at 1 Month	64 Scores on a Scale Standard Deviation 27	71 Scores on a Scale Standard Deviation 27	60 Scores on a Scale Standard Deviation 26	58 Scores on a Scale Standard Deviation 26	70 Scores on a Scale Standard Deviation 21
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	59 Scores on a Scale Standard Deviation 40	51 Scores on a Scale Standard Deviation 45	51 Scores on a Scale Standard Deviation 44	43 Scores on a Scale Standard Deviation 41
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	68 Scores on a Scale Standard Deviation 40	78 Scores on a Scale Standard Deviation 38	67 Scores on a Scale Standard Deviation 44	79 Scores on a Scale Standard Deviation 34
SF-36 (Health-related Quality of Life Survey) Energy/Fatigue at 1 Month	54 Scores on a Scale Standard Deviation 24	55 Scores on a Scale Standard Deviation 25	51 Scores on a Scale Standard Deviation 21	52 Scores on a Scale Standard Deviation 25	63 Scores on a Scale Standard Deviation 20
SF-36 (Health-related Quality of Life Survey) Mental Health at 1 Month	79 Scores on a Scale Standard Deviation 19	73 Scores on a Scale Standard Deviation 20	82 Scores on a Scale Standard Deviation 15	82 Scores on a Scale Standard Deviation 17	87 Scores on a Scale Standard Deviation 19
SF-36 (Health-related Quality of Life Survey) Social Functioning at 1 Month	52 Scores on a Scale Standard Deviation 16	55 Scores on a Scale Standard Deviation 17	53 Scores on a Scale Standard Deviation 20	78 Scores on a Scale Standard Deviation 26	84 Scores on a Scale Standard Deviation 25
SF-36 (Health-related Quality of Life Survey) Pain at 1 Month	74 Scores on a Scale Standard Deviation 23	69 Scores on a Scale Standard Deviation 27	78 Scores on a Scale Standard Deviation 26	73 Scores on a Scale Standard Deviation 26	80 Scores on a Scale Standard Deviation 29
SF-36 (Health-related Quality of Life Survey) General Health at 1 Month	46 Scores on a Scale Standard Deviation 16	48 Scores on a Scale Standard Deviation 14	48 Scores on a Scale Standard Deviation 18	65 Scores on a Scale Standard Deviation 24	77 Scores on a Scale Standard Deviation 15

SECONDARY outcome

Timeframe: From Procedure to Discharge Visit

Population: All available data has been reported.

In-hospital evaluations: Time in ICU; Time to ambulation; Time to normal diet; Times to possible and actual hospital discharge.

Outcome measures

Outcome measures
Measure	Standard EVAR (IntuiTrak) n=50 Participants EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 Participants Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 Participants Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-in) n=22 Participants PEVAR performed with the ProGlide suture mediated closure system.	PEVAR (ProStar XL Roll-in) n=19 Participants PEVAR performed with the ProStar XL suture mediated closure system.
Clinical Utility Measures ICU Length of Stay, hours	35 Hours Standard Deviation 38	26 Hours Standard Deviation 9.0	31 Hours Standard Deviation 15	33 Hours Standard Deviation 11	12 Hours Standard Deviation 25
Clinical Utility Measures Time to Ambulation, hours	19 Hours Standard Deviation 16	17 Hours Standard Deviation 7.2	16 Hours Standard Deviation 9.1	22 Hours Standard Deviation 13	19 Hours Standard Deviation 14
Clinical Utility Measures Time to Normal Diet, hours	15 Hours Standard Deviation 22	14 Hours Standard Deviation 9.4	10 Hours Standard Deviation 8.4	17 Hours Standard Deviation 7.4	18 Hours Standard Deviation 11

SECONDARY outcome

Timeframe: From Procedure to Discharge Visit

Population: All available data has been reported.

% 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.

Outcome measures

Outcome measures
Measure	Standard EVAR (IntuiTrak) n=50 Participants EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 Participants Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 Participants Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-in) n=22 Participants PEVAR performed with the ProGlide suture mediated closure system.	PEVAR (ProStar XL Roll-in) n=19 Participants PEVAR performed with the ProStar XL suture mediated closure system.
Clinical Utility Measures Foley Catheter	82 percentage of participants	80 percentage of participants	80 percentage of participants	96 percentage of participants	89 percentage of participants
Clinical Utility Measures Central Venous Catheter	20 percentage of participants	38 percentage of participants	38 percentage of participants	18 percentage of participants	11 percentage of participants
Clinical Utility Measures Nasogastric Tube	6.0 percentage of participants	14 percentage of participants	2.0 percentage of participants	14 percentage of participants	0 percentage of participants
Clinical Utility Measures Discharged to SNF/ALF	2.0 percentage of participants	0 percentage of participants	0 percentage of participants	4.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 30 Days

Adverse Events: Number of Participants with All non-serious adverse events in the three arms listed below.

Outcome measures

Outcome measures
Measure	Standard EVAR (IntuiTrak) n=50 Participants EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 Participants Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 Participants Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-in) n=22 Participants PEVAR performed with the ProGlide suture mediated closure system.	PEVAR (ProStar XL Roll-in) n=19 Participants PEVAR performed with the ProStar XL suture mediated closure system.
Number of Participants With All Non-serious Adverse Events Investigations	16 Number of participants	23 Number of participants	19 Number of participants	11 Number of participants	5 Number of participants
Number of Participants With All Non-serious Adverse Events Blood and lymphatic system disorders	3 Number of participants	1 Number of participants	3 Number of participants	4 Number of participants	2 Number of participants
Number of Participants With All Non-serious Adverse Events Gastrointestinal disorders	6 Number of participants	9 Number of participants	4 Number of participants	2 Number of participants	5 Number of participants
Number of Participants With All Non-serious Adverse Events General disorders and administration site conditions	19 Number of participants	12 Number of participants	10 Number of participants	13 Number of participants	9 Number of participants
Number of Participants With All Non-serious Adverse Events Infections and infestations	4 Number of participants	4 Number of participants	2 Number of participants	1 Number of participants	0 Number of participants
Number of Participants With All Non-serious Adverse Events Injury, poisoning and procedural complications	10 Number of participants	13 Number of participants	10 Number of participants	4 Number of participants	5 Number of participants
Number of Participants With All Non-serious Adverse Events Metabolism and nutrition disorders	3 Number of participants	14 Number of participants	2 Number of participants	3 Number of participants	2 Number of participants
Number of Participants With All Non-serious Adverse Events Musculoskeletal and connective tissue disorders	2 Number of participants	0 Number of participants	3 Number of participants	1 Number of participants	2 Number of participants
Number of Participants With All Non-serious Adverse Events Nervous system disorders	2 Number of participants	4 Number of participants	2 Number of participants	1 Number of participants	1 Number of participants
Number of Participants With All Non-serious Adverse Events Psychiatric disorders	2 Number of participants	1 Number of participants	0 Number of participants	1 Number of participants	0 Number of participants
Number of Participants With All Non-serious Adverse Events Renal and urinary disorders	3 Number of participants	3 Number of participants	0 Number of participants	0 Number of participants	4 Number of participants
Number of Participants With All Non-serious Adverse Events Respiratory, thoracic and mediastinal disorders	2 Number of participants	3 Number of participants	2 Number of participants	0 Number of participants	1 Number of participants
Number of Participants With All Non-serious Adverse Events Skin and subcutaneous tissue disorders	2 Number of participants	2 Number of participants	0 Number of participants	1 Number of participants	0 Number of participants
Number of Participants With All Non-serious Adverse Events Surgical and medical procedures	2 Number of participants	2 Number of participants	3 Number of participants	0 Number of participants	0 Number of participants
Number of Participants With All Non-serious Adverse Events Vascular disorders	7 Number of participants	4 Number of participants	1 Number of participants	1 Number of participants	1 Number of participants
Number of Participants With All Non-serious Adverse Events Cardiac disorders	0 Number of participants	1 Number of participants	2 Number of participants	1 Number of participants	0 Number of participants
Number of Participants With All Non-serious Adverse Events Congenital, familial and genetic disorders	0 Number of participants	0 Number of participants	1 Number of participants	0 Number of participants	0 Number of participants
Number of Participants With All Non-serious Adverse Events Reproductive system and breast disorders	0 Number of participants	0 Number of participants	1 Number of participants	0 Number of participants	1 Number of participants

SECONDARY outcome

Timeframe: Through Pre-Discharge Visit

In-hospital evaluations: Contrast media volume used

Outcome measures

Outcome measures
Measure	Standard EVAR (IntuiTrak) n=50 Participants EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 Participants Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 Participants Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-in) n=22 Participants PEVAR performed with the ProGlide suture mediated closure system.	PEVAR (ProStar XL Roll-in) n=19 Participants PEVAR performed with the ProStar XL suture mediated closure system.
Clinical Utility Measure	144 mL Standard Deviation 90	120 mL Standard Deviation 78	123 mL Standard Deviation 56	157 mL Standard Deviation 94	118 mL Standard Deviation 54

SECONDARY outcome

Timeframe: During Procedure

Population: All available data has been reported.

In-hospital evaluations: Anesthesia time; Fluoroscopy time; Time to hemostasis.

Outcome measures

Outcome measures
Measure	Standard EVAR (IntuiTrak) n=50 Participants EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 Participants Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 Participants Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-in) n=22 Participants PEVAR performed with the ProGlide suture mediated closure system.	PEVAR (ProStar XL Roll-in) n=19 Participants PEVAR performed with the ProStar XL suture mediated closure system.
Clinical Utility Measures Anesthesia Time, min	203 Min Standard Deviation 93	181 Min Standard Deviation 65	152 Min Standard Deviation 56	201 Min Standard Deviation 75	2.9 Min Standard Deviation 1.28
Clinical Utility Measures Fluoroscopy Time, min	24 Min Standard Deviation 14	26 Min Standard Deviation 16	22 Min Standard Deviation 8.5	30 Min Standard Deviation 16	25 Min Standard Deviation 13
Clinical Utility Measures Ipsilateral Time to Hemostasis, min	23 Min Standard Deviation 23	9.8 Min Standard Deviation 17	13 Min Standard Deviation 19	7.7 Min Standard Deviation 6.8	5.6 Min Standard Deviation 6.1

SECONDARY outcome

Timeframe: Through Pre-Discharge Visit

Population: All available data has been reported.

In-hospital evaluations: Times to possible and actual hospital discharge.

Outcome measures

Outcome measures
Measure	Standard EVAR (IntuiTrak) n=50 Participants EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 Participants Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 Participants Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (ProGlide Roll-in) n=22 Participants PEVAR performed with the ProGlide suture mediated closure system.	PEVAR (ProStar XL Roll-in) n=19 Participants PEVAR performed with the ProStar XL suture mediated closure system.
Clinical Utility Measures Actual Time to Hospital Discharge, days	1.8 Days Standard Deviation 2.4	1.3 Days Standard Deviation 0.7	1.4 Days Standard Deviation 0.9	1.4 Days Standard Deviation 0.5	2.1 Days Standard Deviation 0.0
Clinical Utility Measures EligibleTime to Hospital Discharge, days	1.76 Days Standard Deviation 2.47	1.2 Days Standard Deviation 0.7	1.29 Days Standard Deviation 0.83	1.3 Days Standard Deviation 0.5	1.4 Days Standard Deviation 1.0

Adverse Events

Standard EVAR (IntuiTrak)

Serious events: 20 serious events

Other events: 42 other events

Deaths: 0 deaths

PEVAR (ProGlide Closure)

Serious events: 13 serious events

Other events: 44 other events

Deaths: 0 deaths

PEVAR (ProstarXL Closure)

Serious events: 19 serious events

Other events: 39 other events

Deaths: 0 deaths

PEVAR (Prostar XL Roll -In)

Serious events: 9 serious events

Other events: 14 other events

Deaths: 0 deaths

PEVAR (ProGlide Roll -In)

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard EVAR (IntuiTrak) n=50 participants at risk EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 participants at risk Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 participants at risk Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (Prostar XL Roll -In) n=19 participants at risk PEVAR performed with the Prostar XL suture mediated closure system.	PEVAR (ProGlide Roll -In) n=22 participants at risk PEVAR performed with the ProGlide suture mediated closure system.
Blood and lymphatic system disorders Blood and Lymph Disorder	6.0% 3/50 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/50 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	3.9% 2/51 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	10.5% 2/19 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Cardiac disorders Cardiac Disorder	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	6.0% 3/50 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	3.9% 2/51 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Gastrointestinal disorders GI Disorder	8.0% 4/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	3.9% 2/51 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
General disorders General Disorder	2.0% 1/50 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/50 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	7.8% 4/51 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.3% 1/19 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	9.1% 2/22 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Infections and infestations Infections and Infestations	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	6.0% 3/50 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.9% 3/51 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Injury, poisoning and procedural complications Injury and Procedural Complications	6.0% 3/50 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	11.8% 6/51 • Number of events 6 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	15.8% 3/19 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Investigations Investigations	8.0% 4/50 • Number of events 6 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	6.0% 3/50 • Number of events 5 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	3.9% 2/51 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Metabolism and nutrition disorders Metabolism/Nutrition Disorders	2.0% 1/50 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/50 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	3.9% 2/51 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.3% 1/19 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/51 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Nervous system disorders Nervous System Disorders	8.0% 4/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/51 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Renal and urinary disorders Renal and Urinary Disorders	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.0% 2/50 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	11.8% 6/51 • Number of events 6 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Respiratory, thoracic and mediastinal disorders Respiratory/Thoracic Disorders	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	3.9% 2/51 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.3% 1/19 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Vascular disorders Vascular Disorders	12.0% 6/50 • Number of events 7 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	11.8% 6/51 • Number of events 7 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	21.1% 4/19 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	9.1% 2/22 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Surgical and medical procedures Surgical/Medical procedure	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	3.9% 2/51 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.

Other adverse events

Other adverse events
Measure	Standard EVAR (IntuiTrak) n=50 participants at risk EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	PEVAR (ProGlide Closure) n=50 participants at risk Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProstarXL Closure) n=51 participants at risk Percutaneous EVAR facilitated by the Prostar XL closure device PEVAR (Prostar XL closure): Percutaneous EVAR facilitated by the Prostar XL closure device	PEVAR (Prostar XL Roll -In) n=19 participants at risk PEVAR performed with the Prostar XL suture mediated closure system.	PEVAR (ProGlide Roll -In) n=22 participants at risk PEVAR performed with the ProGlide suture mediated closure system.
Blood and lymphatic system disorders Blood and Lymph Disorders	8.0% 4/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	7.8% 4/51 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	10.5% 2/19 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	18.2% 4/22 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Cardiac disorders Cardiac Disorders	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.0% 2/50 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	3.9% 2/51 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Eye disorders Eye Disorders	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/50 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/51 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Gastrointestinal disorders GI Disorders	14.0% 7/50 • Number of events 10 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	20.0% 10/50 • Number of events 12 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	7.8% 4/51 • Number of events 5 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	26.3% 5/19 • Number of events 7 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	9.1% 2/22 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
General disorders General Disorders	40.0% 20/50 • Number of events 27 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	24.0% 12/50 • Number of events 15 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	23.5% 12/51 • Number of events 19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	47.4% 9/19 • Number of events 15 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	59.1% 13/22 • Number of events 16 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Infections and infestations Infections and Infestations	8.0% 4/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	12.0% 6/50 • Number of events 8 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.9% 3/51 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Injury, poisoning and procedural complications injury and Procedural Complications	34.0% 17/50 • Number of events 17 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	38.0% 19/50 • Number of events 21 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	35.3% 18/51 • Number of events 21 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	26.3% 5/19 • Number of events 6 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	18.2% 4/22 • Number of events 5 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Investigations Investigations	46.0% 23/50 • Number of events 36 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	62.0% 31/50 • Number of events 54 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	47.1% 24/51 • Number of events 43 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	26.3% 5/19 • Number of events 10 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	50.0% 11/22 • Number of events 23 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Metabolism and nutrition disorders Metabolism/Nutritional Disorders	8.0% 4/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	28.0% 14/50 • Number of events 16 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.9% 3/51 • Number of events 5 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	10.5% 2/19 • Number of events 5 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	13.6% 3/22 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/51 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Nervous system disorders Nervous System Disorders	6.0% 3/50 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	10.0% 5/50 • Number of events 5 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.9% 3/51 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.3% 1/19 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Psychiatric disorders Psychiatric Disorders	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.0% 2/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/51 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Renal and urinary disorders Renal and Urinary Disorders	8.0% 4/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	8.0% 4/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/51 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	21.1% 4/19 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Reproductive system and breast disorders Reproductive Disorders	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/50 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/51 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.3% 1/19 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Respiratory, thoracic and mediastinal disorders Respiratory/Thoracic Disorders	6.0% 3/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	10.0% 5/50 • Number of events 8 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	3.9% 2/51 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.3% 1/19 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Skin and subcutaneous tissue disorders Skin Disorders	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	6.0% 3/50 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/51 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Surgical and medical procedures Surgical/Medical Procedures	6.0% 3/50 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.0% 2/50 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.9% 3/51 • Number of events 3 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Vascular disorders Vascular Disorders	16.0% 8/50 • Number of events 8 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	10.0% 5/50 • Number of events 6 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	15.7% 8/51 • Number of events 9 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	5.3% 1/19 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Musculoskeletal and connective tissue disorders Musculoskeletal	8.0% 4/50 • Number of events 4 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/50 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	7.8% 4/51 • Number of events 7 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	10.5% 2/19 • Number of events 2 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	4.5% 1/22 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.
Congenital, familial and genetic disorders Congenital	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/50 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	2.0% 1/51 • Number of events 1 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/19 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.	0.00% 0/22 • 1 Year All Adverse Events were monitored/assessed without regard to the specific adverse event term.

Additional Information

Elisa Hebb

Endologix

Phone: 949-598-4628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER