ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection

NCT ID: NCT02380716

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2026-04-30

Brief Summary

Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft

Detailed Description

This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft.

Conditions

Aortic Dissection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GORE® Ascending Stent Graft

Treatment with the GORE® Ascending Stent Graft

Group Type: EXPERIMENTAL

GORE® Ascending Stent Graft

Intervention Type: DEVICE

Interventions

GORE® Ascending Stent Graft

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including:

• Primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia
• Ascending aorta compatible with the GORE® Ascending Stent Graft including landing zone true lumen diameter between 24mm - 42mm and total aortic landing zone diameter ≤ 45 mm

2. Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure

3. High surgical risk, as determined by the implanting physician

4. Adequate vascular access via transfemoral or retroperitoneal approach

5. An Informed Consent Form signed by Subject or legally authorized representative

6. Able to comply with protocol requirements including follow-up

Exclusion Criteria

1. Planned aortic valve repair or replacement or coronary artery intervention within 30 days

2. Presence of mechanical heart valve in the aortic position

3. Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta

4. Aortic insufficiency grade 3+ or 4+

5. Known irreversible neurological injury

6. Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome

7. Participation in another drug or medical device study within 1 year of study enrollment

8. Known history of drug abuse

9. Pregnant female at time of informed consent signature

10. Body habitus or other medical condition which prevents adequate visualization of the aorta

11. Systemic infection that could increase the risk of endovascular graft infection

12. Previous thoracic aortic surgery

13. Life expectancy <12 months due to associated non-cardiac co-morbid conditions

14. Subject has known sensitivities or allergies to the device materials

15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin

16. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Southern California- Keck Medicine

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TBE 14-02

Identifier Type: -

Identifier Source: org_study_id