Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study (ELEVATE)

Endologix

Status: Completed

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: Ovation Alto Abdominal Stent Graft System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02949297

771-0013

Details and patient eligibility

About

A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).

Full description

A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA). The primary objective is to evaluate treatment success at 12 months with the Ovation Alto Abdominal Stent Graft system. The study will have up to 16 sites, and up to 75 patients based on attrition rates. The follow-up intervals will be at 1, 6, and 12 months following initial implant procedure.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria include:

1. Patient has adequate iliac/femoral access compatible with the required delivery systems.
2. Patient has non-aneurysmal proximal aortic neck.
3. Patient has non-aneurysmal distal iliac landing zone.

Exclusion Criteria include:

1. Patient has dissecting aneurysm.
2. Patient has acutely ruptured aneurysm.
3. Patient has need for emergent surgery.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Ovation Alto Abdominal Stent Graft System

Other group

Description:

Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.

Treatment:

Device: Ovation Alto Abdominal Stent Graft System