NCT02949297

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Aortic Aneurysm, Abdominal

Interventions

Type	Name	Description
DEVICE	Ovation Alto Abdominal Stent Graft System	Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System

Timeline

• Start date: 2017-03-30
• Primary completion: 2019-03-06
• Completion: 2019-03-06
• First posted: 2016-10-31
• Last updated: 2021-12-22
• Results posted: 2021-12-22

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study