NCT04697784

Post-Approval Study of the TREO Abdominal Stent-Graft System

Post-Approval Study of the TREO Abdominal Stent-Graft System (P190015) in Patients With Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Bolton Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.

Detailed description

This is a prospective, multi-center, non-randomized, single-arm, post-market, non-interventional study of treatment with the TREO Abdominal Stent-Graft in subjects with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms. The study will include a minimum of 300 subjects treated with the TREO Abdominal Stent-Graft at up to 55 investigational sites in the US. The primary objective is the collection of real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	TREO Abdominal Stent-Graft System	The TREO Abdominal Stent-Graft System is intended for the treatment of infrarenal abdominal aortic aneurysms with or without iliac involvement.

Timeline

• Start date: 2021-01-20
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2021-01-06
• Last updated: 2025-06-26

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated device study