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Evaluation of the GORE® Ascending Stent Graft

NCT05800743 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2026-04-28

No results posted yet for this study

Summary

The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.

Conditions

  • Aortic Aneurysm, Thoracic
  • Pseudoaneurysm
  • Aortic Dissection
  • Aorta; Lesion

Interventions

DEVICE

GORE® Ascending Stent Graft (ASG device)

Endovascular aortic repair of the ascending aorta

DEVICE

GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device)

Endovascular aortic repair of the ascending aorta/aortic arch

PROCEDURE

Surgery

Open surgical repair of the ascending aorta and/or the aortic arch

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Eric Roselli, MD · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2029-10-31
Completion
2034-01-31
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 NCT05800743 on ClinicalTrials.gov