Zenith® Low Profile AAA Endovascular Graft

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02535065
• Date of registration: 26/08/2015
• Prospective Registration: No
• Primary sponsor: Cook Research Incorporated
• Public title: Zenith® Low Profile AAA Endovascular Graft
• Scientific title: Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft
• Date of first enrolment: August 2014
• Target sample size: 62
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02535065
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aortoiliac Aneurysms

Iliac Aneurysms

Abdominal Aortic Aneurysms

Intervention(s)

Device: Zenith Low Profile AAA Endovascular Graft and ancillary components

Primary Outcome(s)

Number of Patients With Technical Success [Time Frame: 12 months]

Number of Patients Without Major Adverse Events [Time Frame: 30 days]

Secondary ID(s)

08-013 Spiral-Z

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02535065