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

NCT02380716 | Completed Results DMC

• 1 other identifier: TBE 14-02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Dissection

Keywords

type A dissection

Outcome Measures

Primary Outcomes (1)

• All Cause Mortality at 30 Days Post-procedure

  Number of subjects that die of any cause within 30 days post-procedure

  30 days post-procedure

Secondary Outcomes (6)

• Successful Dissection Treatment (Technical Success)

  At removal of device deployment system, up to conclusion of procedure

• Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months

  30 days, 6 months, and 12 months post procedure

• Individual MACCE Components Through 30 Days, 6 Months, and 12 Months

  30 days, 6 months, and 12 months post procedure

• Aorta-related Mortality

  30 days post procedure

• Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months

  30 days, 6 months, and 12 months post procedure

Study Arms (1)

GORE® Ascending Stent Graft

EXPERIMENTAL

Treatment with the GORE® Ascending Stent Graft

Device: GORE® Ascending Stent Graft

Interventions

GORE® Ascending Stent Graft DEVICE

GORE® Ascending Stent Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure
• High surgical risk, as determined by the implanting physician
• Adequate vascular access via transfemoral or retroperitoneal approach
• An Informed Consent Form signed by Subject or legally authorized representative
• Able to comply with protocol requirements including follow-up

You may not qualify if:

• Planned aortic valve repair or replacement or coronary artery intervention within 30 days
• Presence of mechanical heart valve in the aortic position
• Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta
• Aortic insufficiency grade 3+ or 4+
• Known irreversible neurological injury
• Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
• Participation in another drug or medical device study within 1 year of study enrollment
• Known history of drug abuse
• Pregnant female at time of informed consent signature
• Body habitus or other medical condition which prevents adequate visualization of the aorta
• Systemic infection that could increase the risk of endovascular graft infection
• Previous thoracic aortic surgery
• Life expectancy \<12 months due to associated non-cardiac co-morbid conditions
• Subject has known sensitivities or allergies to the device materials
• Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

University of Southern California- Keck Medicine

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Results Point of Contact

• Title: Greg Miller
• Organization: W. L. Gore & Associates

gmiller@wlgore.com

623-234-5910

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 5, 2015
• Study Start: August 1, 2015
• Primary Completion: February 26, 2021
• Study Completion: April 1, 2026
• Last Updated: May 13, 2026
• Results First Posted: February 27, 2023

Record last verified: 2026-04

Locations

US (1)