Zenith® Low Profile AAA Endovascular Graft

Cook Group

Status: Completed

Conditions: Aortoiliac Aneurysms; Iliac Aneurysms; Abdominal Aortic Aneurysms

Treatments: Device: Zenith Low Profile AAA Endovascular Graft and ancillary components

Study type: Interventional

Funder types: Industry

Identifiers

NCT02535065

08-013 Spiral-Z

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Endovascular Graft

Experimental group

Description:

The Zenith Low Profile AAA Endovascular Graft and ancillary components

Treatment:

Device: Zenith Low Profile AAA Endovascular Graft and ancillary components