CompletedNot Applicable

Zenith® Low Profile AAA Endovascular Graft

United States62 participantsStarted 2014-08

Plain-language summary

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject has at least one of the following * Aortic or aortoiliac aneurysm * Iliac aneurysm * Aneurysm with a history of growth Exclusion Criteria: * Less than 18 years of age * Inability or refusal to give informed consent * Disease considerations that would compromise patient safety or study outcomes * Pregnant of breastfeeding or planning on becoming pregnant with 60 months * Unwilling to comply with the follow-up schedule

What they're measuring

Number of Patients Without Major Adverse Events Within 30 Days

Timeframe: 30 days

Number of Patients With Device Success

Timeframe: 12 months

Trial details

NCT IDNCT02535065

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-01-23

Results submitted2018-04-11

View on ClinicalTrials.gov More Abdominal Aortic Aneurysms trials