Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT01070069
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01070069
Study Brief:
Protocol Section:
NCT01070069