Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

Conditions

• Acute Aortic Dissection
• Aortic Arch Aneurysm
• Aortic Arch Dissection
• Chronic Aortic Dissection

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Arcevo™ LSA Hybrid Stent Graft System — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Nov 4, 2025

Status verified

May 2026

Primary completion

Apr 30, 2028

Completion

Jul 31, 2032

Study Design

Enrollment

132 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arcevo LSA
  The Primary study arm will consist of patients with an aortic aneurysm or chronic aortic dissection (n=117). The Secondary study arm will include patients with acute or subacute aortic dissections (n=15).

Primary Outcome Measure

Composite Rate of Patients Free From ≥1 Major Adverse Event [ Time Frame: 1 year post-index procedure of LSA stent graft implant ]

Central Contacts

• Erin M Adams, MSPH
  800-438-8285
  [email protected]

Locations (19)

Find similar trials in Birmingham, AL

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