N/A
N=192
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
Abdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT01070069 ↗Enrolled (actual)
192
Serious AEs
34.9%
Results posted
Jun 2022
Primary outcome: 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). — 39; 44; 40; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PEVAR (ProGlide closure) (Device); SEVAR (IntuiTrak) (Device); PEVAR (Prostar XL closure) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endologix
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
39; 44; 40; 11; 6; 11 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
13; 5; 16; 6; 9; 3 | — |
| SECONDARY SF-36 (Health-related Quality of Life Survey) |
64; 71; 60; 58; 70; 47 | — |
| SECONDARY Clinical Utility Measures |
1.76; 1.2; 1.29; 1.3; 1.4; 1.8 | — |
| SECONDARY Clinical Utility Measures |
1.76; 1.2; 1.29; 1.3; 1.4; 1.8 | — |
| SECONDARY Number of Participants With All Non-serious Adverse Events |
3; 1; 3; 4; 2; 6 | — |
| SECONDARY Clinical Utility Measure |
144; 120; 123; 157; 118 | — |
| SECONDARY Clinical Utility Measures |
1.76; 1.2; 1.29; 1.3; 1.4; 1.8 | — |
| SECONDARY Clinical Utility Measures |
1.76; 1.2; 1.29; 1.3; 1.4; 1.8 | — |
Summary
To determine the safety and effectiveness of PEVAR.
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 1.7 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
Data sourced from ClinicalTrials.gov (NCT01070069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.