Trials / Recruiting
RecruitingNCT07089576
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
A Prospective, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA in the Open Repair of Aortic Arch Aneurysms and Dissections
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- Sponsor
- Artivion Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending thoracic aorta, with or without the involvement of the ascending aorta.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Arcevo™ LSA Hybrid Stent Graft System | The Arcevo LSA Hybrid Stent Graft System is an implantable aortic stent graft with LSA branch which is preloaded onto a delivery system and implanted during an open surgical procedure, or more specifically a total arch replacement procedure. The device is intended for use with a proximal surgical graft (not supplied). If additional coverage is needed, a protocol specified thoracic endovascular aortic repair (TEVAR) device may be used. |
Timeline
- Start date
- 2025-11-04
- Primary completion
- 2028-04-01
- Completion
- 2032-07-01
- First posted
- 2025-07-28
- Last updated
- 2026-03-04
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07089576. Inclusion in this directory is not an endorsement.