General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06001918

Background Information

This is a prospective, randomized, controlled, multi-center, clinical trial to demonstrate efficacy of the Nectero EAST System for stabilization of abdominal aortic aneurysms with a maximum diameter of 3.5-5.0 cm.
The trial will enroll and randomize at least 400 subjects, randomized 1:1; to the Treatment arm or Control arm. All subjects will be followed at designated intervals at 30/60days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years. The purpose of this trial is to demonstrate the efficacy of the Nectero EAST System by reducing AAA clinical events of small to mid-sized aneurysms compared to current standard of care (surveillance). In addition, the study will evaluate:

  • treatment-related adverse events up to 30-days and 
  • the aneurysmal growth rate over time as compared to the untreated Control arm. 

For additional information, please visit: https://clinicaltrials.gov/study/NCT06001918

Offered At

 Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042

8100 Innovation Park Drive 
Fairfax, VA 22031

 
Principal Investigator

Kendal Endicott, MD

Eligibility Information

  • Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
  • Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
  • Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
  • Subject has > three-year life expectancy.
  • Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 30/60 day, 6, 12, 18, 24 months and annually up to 5 years).

Ineligibility Information

  • Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
  • Subject's aneurysm is thoracic, suprarenal or juxtarenal.
  • Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
  • Subject has undergone other major surgery within the 30 days prior to enrollment.
  • Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
  • Subjects with saccular AAA.
  • Subjects with rapidly expanding AAA (previous diameter increases of ≥ 0.5 cm in 6 months or ≥ 1 cm in 1 year) as these should be evaluated for immediate repair.