GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections

NCT06827990 | Recruiting DMC FDA Device

• 1 other identifier: ASG 24-02
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 16

Brief Summary

To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.

Conditions

Aortic Dissection

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Composite of the following events: Death ≤30 days of the index endovascular procedure, or during initial hospitalization, whichever is later Disabling Stroke ≤30 days following the index endovascular procedure

  30 Days

• Primary Effectiveness Endpoint

  Clinical Success, a composite of: Assisted Technical Success (at end of index endovascular procedure) Absence of the following (cumulative through 30-days, except as specified): Aortic rupture Death ≤30days of the index endovascular procedure, or during initial hospitalization, whichever is later Study Device Reintervention Conversion to open surgical repair

  30 Days

Secondary Outcomes (1)

• Secondary Endpoint

  1 Year

Study Arms (2)

Primary

EXPERIMENTAL

A hypothesis driven analysis of the safety and effectiveness of the GORE® Ascending Stent Graft (ASG) device alone in the ascending aorta. Dissection chronicity in the primary arm must be 30 days or less from symptom onset to index endovascular procedure.

Device: GORE® Ascending Stent Graft (ASG device)

Secondary

EXPERIMENTAL

Descriptive analysis of use of the ASG device in patients who are not eligible for treatment in the primary arm. Dissection chronicity up to 90 days from symptom onset until the first study procedure is allowed in the secondary arm.

Device: GORE® Ascending Stent Graft (ASG device)

Interventions

GORE® Ascending Stent Graft (ASG device) DEVICE

Endovascular aortic repair of the ascending aorta

Primary; Secondary

Eligibility Criteria

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

You may qualify if:

• The subject is/has:
• De novo Type A aortic dissection (≤30 days from symptom onset to index endovascular procedure) compatible with the treatment requirements of the ASG device.
• Primarily intended to be treated by placement of the ASG device in the ascending aorta. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator.
• Anatomic compatibility of the ascending aorta required for implanting the ASG device:
• a) Proximal Aortic Landing Zone: i. Primary entry tear must be in the ascending aorta and ≥ 2 cm distal to the most distal coronary artery ostium.
• ii. Total aortic diameter between 27mm - 48mm iii. Landing zone cannot be heavily calcified or thrombosed. b) Distal Aortic Landing Zone: i. Primary entry tear must be in the ascending aorta and ≥ 2 cm proximal to BCA ostium.
• c) Adequate aortic length
• The Aortic Treatment Team (as defined by the protocol) attest endovascular repair is in the best interest of the patient AND considers the patient to be high-risk for open surgical repair by meeting at least one of the following criteria:
• ≥80 years of age
• Body mass index (BMI) ≥ 35 kg/m2
• History of Respiratory Insufficiency (defined by home O2 usage, exertional dyspnea, imaging evidence of COPD, previous evidence of compromised pulmonary function tests (PFT) on spirometry or other factors as determined by the Investigator)
• Prior Cardiac Surgery
• Hostile Chest (VARC-2 Definition)
• Clinical Frailty Scale 3-7
• Clinical malperfusion (head, gut, lower extremity)

You may not qualify if:

• The subject is/has:
• Mechanical heart valve in the aortic position.
• Aortic insufficiency grade 3 or greater confirmed during TEE pre-implant.
• Indwelling intravascular device that would interfere with or result in contact with planned repair (e.g., contiguous arch graft, LVAD, TAVR device in continuity with aortic tear).
• Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome).
• Participation in investigational drug or medical device study within one year of enrollment unless approved by the Sponsor.
• Known history of drug abuse within one year of treatment which would affect the ability to obtain follow-up.
• Pregnant at time of procedure.
• Active infected aorta, mycotic aneurysm.
• Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).
• Life expectancy \<12 months due to presence of another comorbid condition.
• Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
• Coronary malperfusion.
• Catastrophic neurological complications in the 30 days prior to the dissection diagnosis (e.g., progressively worsening symptoms, coma, Glasgow Coma Scale \<=8).
• Aortic fistula.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (16)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Corewell Health System

Grand Rapids, Michigan, 49503, United States

RECRUITING

Washington University School of Medicine - St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 18104, United States

RECRUITING

The Methodist Hospital Houston

Houston, Texas, 77030, United States

RECRUITING

Baylor Research Institute

Plano, Texas, 75093, United States

RECRUITING

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

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

Study Officials

• Eric Roselli, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Study Manager

CONTACT

800-437-8181; ARISE3Pivotal@wlgore.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)