Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial | NCT01070069

Status Module

Name	Class
Abbott Medical Devices	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard EVAR (IntuiTrak)	Active Comparator	EVAR using standard vascular exposure for access	Device: SEVAR (IntuiTrak)
PEVAR (ProGlide closure)	Experimental	Percutaneous EVAR facilitated by the ProGlide closure device	Device: PEVAR (ProGlide closure)
PEVAR (ProstarXL closure)	Experimental	Percutaneous EVAR facilitated by the Prostar XL closure device	Device: PEVAR (Prostar XL closure)

Name	Type	Description	Arm Group Labels	Other Names
PEVAR (ProGlide closure)	Device	Percutaneous EVAR facilitated by the ProGlide closure device	PEVAR (ProGlide closure)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC).	The primary endpoint for the trial is 30-day Treatment Success, defined as the composite of the following as determined by the independent physician adjudicator: Procedural technical success Absence of vascular complication Absence of major adverse event	30 days

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Serious Adverse Events	SAEs for Standard EVAR, PEVAR (ProGlide closure), PEVAR (ProstarXL closure), PEVAR (ProGlide Roll-in) ,PEVAR (ProstarXL Roll-in).	30 days
SF-36 (Health-related Quality of Life Survey)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female at least 18 years old
Informed consent form understood and signed and patient agrees to all follow-up visits
Abdominal aortic aneurysm (AAA) with maximum diameter ≥5cm, or in the range of 4 to 5cm which has increased by 0.5cm or more in the past six months
Have a suitable ipsilateral common femoral artery for percutaneous access using a 'Pre-close' technique as detailed in the protocol
Anatomically eligible for the IntuiTrak System per the FDA-approved indications for use (IFU)

Exclusion Criteria:

Life expectancy <1 year as judged by the investigator;
Psychiatric or other condition that may interfere with the study;
Participating in the enrollment or 30-day follow-up phase of another clinical study;
Known allergy to any device component;
Coagulopathy or uncontrolled bleeding disorder;
Ruptured, leaking, or mycotic aneurysm;
Serum creatinine (S-Cr) level >1.7 mg/dL;
Traumatic vascular injury;
Active systemic or localized groin infection;
Connective tissue disease (e.g., Marfan's Syndrome);
Renal transplant patient;
Recent (within prior three months) cerebrovascular accident or myocardial infarction;
Planned major intervention or surgery within 30 days following the EVAR procedure;
Requirement for an arterial conduit at the access site;
Morbidly obese (BMI≥40);
Calcification throughout the common femoral artery (CFA) target area anterior wall or circumferentially or over >50% of the posterior wall;
Femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm;
Evidence of prior common femoral artery surgery (e.g., groin incision);
Prior clip-based vascular closure device placement in either arterial access site;
Collagen-based vascular closure device placement in either arterial access site within the prior 90 days;
Femoral artery needle puncture in either arterial access site within the prior 30 days;
Hematoma at the ipsilateral arterial access site
Significant scarring at the ipsilateral arterial access site

Name	Affiliation	Role
Edward B Diethrich, MD	Endologix	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda VA Medical Center		Loma Linda	California	92357	United States
VA San Diego

PubMed Identifier	Type	Citation	Retractions
36629152	Derived	Wang Q, Wu J, Ma Y, Zhu Y, Song X, Xie S, Liang F, Gimzewska M, Li M, Yao L. Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair. Cochrane Database Syst Rev. 2023 Jan 11;1(1):CD010185. doi: 10.1002/14651858.CD010185.pub4.
24440678	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
FG001	PEVAR (ProGlide Closure)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Health-related Quality of Life per the standardized short form 36-item survey [SF-36]); self-reported groin pain per a Pain Scale.

It comprises 36 questions which cover eight domains of health:

Physical Function (Range 0 to 100)
Social Functioning (Range 0 to 100)
Role Limitations due to physical Health (Range o to 100)
Pain (Range 0 to 100)
Mental Health (Range 0 to 100)
Role limitations due to emotional health (Range 0 to 100)
Energy and fatigue (Range 0 to 100)
General health (Range 0 to 100)

Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Arm/Group Information

ID	Title	Description
BG000	SEVAR	Standard vascular exposure cutdown approach (SEVAR=Control).
BG001	PEVAR Perclose ProGlide	PEVAR performed with the Perclose ProGlide suture mediated closure system.
BG002	PEVAR Prostar XL	PEVAR performed with the Prostar XL suture mediated closure system.
BG003	PEVAR (Prostar XL Roll -In)	PEVAR performed with the Prostar XL suture mediated closure system.
BG004	PEVAR (ProGlide Roll -In)	PEVAR performed with the Prostar XL suture mediated closure system.
BG005	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
OG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
OG002	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

Units	Counts
Participants	OG00050 OG00150 OG00251

Title

Denominators

Categories

Title	Measurements
Subjects with Treatment Success	OG00039 OG00144 OG00240
Subjects with unsuccessful Treatment

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).

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

Posted

Number

participants

30 days

ID	Title	Description
OG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
OG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
OG002	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
OG003	PEVAR (ProGlide Roll-in)	PEVAR performed with the ProGlide suture mediated closure system.

Secondary

SF-36 (Health-related Quality of Life Survey)

Health-related Quality of Life per the standardized short form 36-item survey [SF-36]); self-reported groin pain per a Pain Scale.

It comprises 36 questions which cover eight domains of health:

Physical Function (Range 0 to 100)
Social Functioning (Range 0 to 100)
Role Limitations due to physical Health (Range o to 100)
Pain (Range 0 to 100)
Mental Health (Range 0 to 100)
Role limitations due to emotional health (Range 0 to 100)
Energy and fatigue (Range 0 to 100)
General health (Range 0 to 100)

All available data has been reported.

Posted

Mean

Standard Deviation

Scores on a Scale

30 days

ID	Title	Description
OG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
OG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
OG002

Secondary

Clinical Utility Measures

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

All available data has been reported.

Posted

Mean

Standard Deviation

Hours

From Procedure to Discharge Visit

ID	Title	Description
OG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
OG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
OG002	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
OG003	PEVAR (ProGlide Roll-in)	PEVAR performed with the ProGlide suture mediated closure system.

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.

All available data has been reported.

Posted

Number

percentage of participants

From Procedure to Discharge Visit

ID	Title	Description
OG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
OG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
OG002	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
OG003	PEVAR (ProGlide Roll-in)	PEVAR performed with the ProGlide suture mediated closure system.

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.

Posted

Number

Number of participants

30 Days

ID	Title	Description
OG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
OG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
OG002	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
OG003	PEVAR (ProGlide Roll-in)	PEVAR performed with the ProGlide suture mediated closure system.
OG004

Secondary

Clinical Utility Measure

In-hospital evaluations: Contrast media volume used

Posted

Mean

Standard Deviation

Through Pre-Discharge Visit

ID	Title	Description
OG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
OG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
OG002	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
OG003	PEVAR (ProGlide Roll -In)	PEVAR performed with the ProGlide suture mediated closure system.
OG004	PEVAR (Prostar XL Roll -In)

Secondary

Clinical Utility Measures

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

All available data has been reported.

Posted

Mean

Standard Deviation

Min

During Procedure

ID	Title	Description
OG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
OG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
OG002	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
OG003	PEVAR (ProGlide Roll -In)	PEVAR performed with the ProGlide suture mediated closure system.

Secondary

Clinical Utility Measures

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

All available data has been reported.

Posted

Mean

Standard Deviation

Days

Through Pre-Discharge Visit

ID	Title	Description
OG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR
OG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device
OG002	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
OG003	PEVAR (ProGlide Roll-in)	PEVAR performed with the ProGlide suture mediated closure system.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard EVAR (IntuiTrak)	EVAR using standard vascular exposure for access SEVAR (IntuiTrak): Standard vascular exposure for access prior to EVAR	20	50	42	50
EG001	PEVAR (ProGlide Closure)	Percutaneous EVAR facilitated by the ProGlide closure device PEVAR (ProGlide closure): Percutaneous EVAR facilitated by the ProGlide closure device	13	50	44	50
EG002	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	19	51	39	51
EG003	PEVAR (Prostar XL Roll -In)	PEVAR performed with the Prostar XL suture mediated closure system.	9	19	14	19
EG004	PEVAR (ProGlide Roll -In)	PEVAR performed with the ProGlide suture mediated closure system.	6	22	20	22

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood and Lymph Disorder	Blood and lymphatic system disorders	Custom Coding	Systematic Assessment	EG0003 events3 affected50 at risk EG0011 events1 affected50 at risk EG0022 events2 affected51 at risk EG0032 events2 affected19 at risk EG004
Cardiac Disorder	Cardiac disorders	Custom Coding	Systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected50 at risk EG0022 events2 affected51 at risk EG003
GI Disorder	Gastrointestinal disorders	Custom Coding	Systematic Assessment	EG0004 events4 affected50 at risk EG0012 events2 affected50 at risk EG0024 events2 affected51 at risk EG003
General Disorder	General disorders	Custom Coding	Systematic Assessment	EG0001 events1 affected50 at risk EG0011 events1 affected50 at risk EG0024 events4 affected51 at risk EG003
Infections and Infestations	Infections and infestations	Custom Coding	Systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected50 at risk EG0023 events3 affected51 at risk EG003
Injury and Procedural Complications	Injury, poisoning and procedural complications	Custom Coding	Systematic Assessment	EG0003 events3 affected50 at risk EG0012 events1 affected50 at risk EG0026 events6 affected51 at risk EG003
Investigations	Investigations	Custom Coding	Systematic Assessment	EG0006 events4 affected50 at risk EG0015 events3 affected50 at risk EG0023 events2 affected51 at risk EG003
Metabolism/Nutrition Disorders	Metabolism and nutrition disorders	Custom Coding	Systematic Assessment	EG0001 events1 affected50 at risk EG0011 events1 affected50 at risk EG0022 events2 affected51 at risk EG003
Neoplasms	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Custom Coding	Systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected50 at risk EG0021 events1 affected51 at risk EG003
Nervous System Disorders	Nervous system disorders	Custom Coding	Systematic Assessment	EG0004 events4 affected50 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk EG003
Renal and Urinary Disorders	Renal and urinary disorders	Custom Coding	Systematic Assessment	EG0002 events2 affected50 at risk EG0013 events2 affected50 at risk EG0026 events6 affected51 at risk EG003
Respiratory/Thoracic Disorders	Respiratory, thoracic and mediastinal disorders	Custom Coding	Systematic Assessment	EG0002 events2 affected50 at risk EG0010 events0 affected50 at risk EG0022 events2 affected51 at risk EG003
Vascular Disorders	Vascular disorders	Custom Coding	Systematic Assessment	EG0007 events6 affected50 at risk EG0012 events1 affected50 at risk EG0027 events6 affected51 at risk EG003
Surgical/Medical procedure	Surgical and medical procedures	Custom Coding	Systematic Assessment	EG0002 events2 affected50 at risk EG0010 events0 affected50 at risk EG0022 events2 affected51 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood and Lymph Disorders	Blood and lymphatic system disorders	Custom Coding	Systematic Assessment	EG0004 events4 affected50 at risk EG0012 events2 affected50 at risk EG0024 events4 affected51 at risk EG0033 events2 affected19 at risk EG004
Cardiac Disorders	Cardiac disorders	Custom Coding	Systematic Assessment	EG0002 events2 affected50 at risk EG0013 events2 affected50 at risk EG0022 events2 affected51 at risk EG003
Eye Disorders	Eye disorders	Custom Coding	Systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk EG003
GI Disorders	Gastrointestinal disorders	Custom Coding	Systematic Assessment	EG00010 events7 affected50 at risk EG00112 events10 affected50 at risk EG0025 events4 affected51 at risk EG003
General Disorders	General disorders	Custom Coding	Systematic Assessment	EG00027 events20 affected50 at risk EG00115 events12 affected50 at risk EG00219 events12 affected51 at risk EG003
Infections and Infestations	Infections and infestations	Custom Coding	Systematic Assessment	EG0004 events4 affected50 at risk EG0018 events6 affected50 at risk EG0024 events3 affected51 at risk EG003
injury and Procedural Complications	Injury, poisoning and procedural complications	Custom Coding	Systematic Assessment	EG00017 events17 affected50 at risk EG00121 events19 affected50 at risk EG00221 events18 affected51 at risk EG003
Investigations	Investigations	Custom Coding	Systematic Assessment	EG00036 events23 affected50 at risk EG00154 events31 affected50 at risk EG00243 events24 affected51 at risk EG003
Metabolism/Nutritional Disorders	Metabolism and nutrition disorders	Custom Coding	Systematic Assessment	EG0004 events4 affected50 at risk EG00116 events14 affected50 at risk EG0025 events3 affected51 at risk EG003
Neoplasms	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Custom Coding	Systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk EG003
Nervous System Disorders	Nervous system disorders	Custom Coding	Systematic Assessment	EG0003 events3 affected50 at risk EG0015 events5 affected50 at risk EG0023 events3 affected51 at risk EG003
Psychiatric Disorders	Psychiatric disorders	Custom Coding	Systematic Assessment	EG0002 events2 affected50 at risk EG0014 events2 affected50 at risk EG0020 events0 affected51 at risk EG003
Renal and Urinary Disorders	Renal and urinary disorders	Custom Coding	Systematic Assessment	EG0004 events4 affected50 at risk EG0014 events4 affected50 at risk EG0020 events0 affected51 at risk EG003
Reproductive Disorders	Reproductive system and breast disorders	Custom Coding	Systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected50 at risk EG0021 events1 affected51 at risk EG003
Respiratory/Thoracic Disorders	Respiratory, thoracic and mediastinal disorders	Custom Coding	Systematic Assessment	EG0004 events3 affected50 at risk EG0018 events5 affected50 at risk EG0022 events2 affected51 at risk EG003
Skin Disorders	Skin and subcutaneous tissue disorders	Custom Coding	Systematic Assessment	EG0002 events2 affected50 at risk EG0013 events3 affected50 at risk EG0020 events0 affected51 at risk EG003
Surgical/Medical Procedures	Surgical and medical procedures	Custom Coding	Systematic Assessment	EG0003 events3 affected50 at risk EG0012 events2 affected50 at risk EG0023 events3 affected51 at risk EG003
Vascular Disorders	Vascular disorders	Custom Coding	Systematic Assessment	EG0008 events8 affected50 at risk EG0016 events5 affected50 at risk EG0029 events8 affected51 at risk EG003
Musculoskeletal	Musculoskeletal and connective tissue disorders	Custom Coding	Systematic Assessment	EG0004 events4 affected50 at risk EG0011 events1 affected50 at risk EG0027 events4 affected51 at risk EG003
Congenital	Congenital, familial and genetic disorders	Custom Coding	Systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk EG003

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases