Active — Not RecruitingNot Applicable

EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

United States98 participantsStarted 2017-12-01

Plain-language summary

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female at least 18 years old;
✓. Informed consent form understood and signed
✓. Patient agrees to all follow-up visits;
✓. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA \<4 cm will be included.
✓. Anatomically eligible for the Nellix System (per Instructions For Use):
✓. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
✓. Aneurysm blood lumen diameter ≤60mm;
✓. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;

Exclusion criteria

✕. Life expectancy \<2 years as judged by the Investigator;
✕. Psychiatric or other condition that may interfere with the study;
✕. Participating in another clinical study;
✕. Known allergy or contraindication to any device material;
✕. Coagulopathy or uncontrolled bleeding disorder;
✕. Ruptured, leaking or mycotic aneurysm;
✕. Serum creatinine (S-Cr) level \>2.0 mg/dL;
✕. CVA or MI within three months of enrollment/treatment;

What they're measuring

Safety: Major Adverse Events (MAE)

Timeframe: 30 days

Effectiveness: Rate of Treatment Success

Timeframe: 2 year

Trial details

NCT IDNCT03298477

SponsorEndologix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-07

Results submitted2024-10-11

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm Without Rupture trials