Post-Approval Study of the TREO Abdominal Stent-Graft System (TREO PAS)
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- STATUS
- Recruiting
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- End date
- Jul 31, 2027
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- participants needed
- 300
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- sponsor
- Bolton Medical
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.
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.
Details
| Condition | Abdominal Aortic Aneurysm |
|---|---|
| Treatment | TREO Abdominal Stent-Graft System |
| Clinical Study Identifier | NCT04697784 |
| Sponsor | Bolton Medical |
| Last Modified on | 24 May 2022 |
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