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Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

NCT07089576 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-22

No results posted yet for this study

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

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

Interventions

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.

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • Artivion Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2028-04-30
Completion
2032-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07089576 on ClinicalTrials.gov