GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections (ARISE III)

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

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection
• Intervention / Treatment: Device: GORE® Ascending Stent Graft (ASG device)

Detailed Description

This pivotal investigation is a prospective, multicenter, non-randomized, single-arm study to evaluate the safety and effectiveness of the ASG device for the treatment of de novo Type A aortic dissections in patients considered to be high-risk for open surgical repair.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Study Manager; Phone Number: 800-437-8181; Email: ARISE3Pivotal@wlgore.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Principal Investigator: Kyle Eudailey, MD
      • Contact: Shelley Schultz; Phone Number: 205-641-7880; Email: shelleyschultz@uabmc.edu
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
      • Principal Investigator: Fernando Fleischman, MD
      • Contact: Arnoldo Gutierres-Abrica; Email: arnoldo.gutierres-abrica@med.usc.edu
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • University of Florida
      • Principal Investigator: Thomas Beaver, MD
      • Contact: Jessica Cobb; Phone Number: 352-273-7837; Email: jessica.cobb@surgery.ufl.edu
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University School of Medicine
      • Principal Investigator: Bradley Leshnower, MD
      • Contact: Maialen Odriozola; Email: maialen.odriozolarodriguez@emory.edu
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medicine
      • Contact: Andrea Silverman; Phone Number: 312-921-0042; Email: andrea.silverman@nm.org
      • Principal Investigator: Christopher Mehta, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Principal Investigator: Joel Corvera, MD
      • Contact: Emily Rettig; Email: erettig@iuhealth.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Arminder Jassar, MD
      • Contact: Bronwen Rees-Widermann; Email: brees-wiedemann@mgh.harvard.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Himanshu Patel, MD
      • Contact: China Green; Phone Number: 734-936-7731; Email: chjgreen@med.umich.edu
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Corewell Health System
      • Principal Investigator: Stephane Leung, MD
      • Contact: Denise Wittenbach; Email: denise.wittenbach@corewellhealth.org
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine - St. Louis
      • Contact: Allison Schuck; Email: aschuck@wustl.edu
      • Principal Investigator: Puja Kachroo, MD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Principal Investigator: G. Chad Hughes, MD
      • Contact: Rachael Abuin; Phone Number: 936-697-0740; Email: rachael.abuin@duke.edu
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Principal Investigator: Patrick Vargo, MD
      • Contact: Larissa Schaaf, RN; Phone Number: 216-445-4437; Email: schaafl@ccf.org
      • Contact: Brett Duncan, BS; Phone Number: 216-445-9048; Email: DUNCANB2@ccf.org
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • Ohio Health Research Institute
      • Contact: Theresa Khuat; Email: Theresa.Khuat@ohiohealth.com
      • Principal Investigator: Jefferson Lyons, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 18104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Principal Investigator: Nimesh Desai, MD
      • Contact: Tara Manzari; Email: Tara.Manzari@PennMedicine.upenn.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The Methodist Hospital Houston
      • Principal Investigator: Marvin Atkins, MD
      • Contact: Riya Singh; Phone Number: 713-441-3142; Email: rsingh4@houstonmethodist.org
    • Plano, Texas, United States, 75093
      • Recruiting
      • Baylor Research Institute
      • Principal Investigator: William Brinkman, MD
      • Contact: Niat Tekle; Phone Number: 469-814-4853; Email: niat.tekle@bswhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria - Primary Arm:

The subject is/has:

1. De novo Type A aortic dissection (≤30 days from symptom onset to index endovascular procedure) compatible with the treatment requirements of the ASG device.
2. 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.

3. 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

4. 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:

   1. ≥80 years of age
   2. Body mass index (BMI) ≥ 35 kg/m2
   3. 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)
   4. Prior Cardiac Surgery
   5. Hostile Chest (VARC-2 Definition)
   6. Clinical Frailty Scale 3-7
   7. Clinical malperfusion (head, gut, lower extremity)
   8. Transfusion is not possible (e.g., Jehovah's Witness)
   9. Renal Dialysis prior to aortic dissection
   10. Chronic renal insufficiency (eGFR<60 without dialysis or other documented history of chronic kidney disease prior to dissection)
5. Age ≥18 years at time of informed consent signature.
6. Adequate vascular access via transfemoral or retroperitoneal approach.
7. Informed Consent Form (ICF) signed by the subject or legally authorized representative.
8. Agrees to comply with protocol requirements, including imaging and 5-year follow-up, as the subject's condition allows.

Exclusion Criteria - Primary Arm

The subject is/has:

1. Mechanical heart valve in the aortic position.
2. Aortic insufficiency grade 3 or greater confirmed during TEE pre-implant.
3. 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).
4. Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome).
5. Participation in investigational drug or medical device study within one year of enrollment unless approved by the Sponsor.
6. Known history of drug abuse within one year of treatment which would affect the ability to obtain follow-up.
7. Pregnant at time of procedure.
8. Active infected aorta, mycotic aneurysm.
9. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).
10. Life expectancy <12 months due to presence of another comorbid condition.
11. Known sensitivities or allergies to the device materials (Previous instance of Heparin Induced Thrombocytopenia type 2 [HIT-2], known hypersensitivity to heparin, or a history of a hypercoagulability disorder and/or state should be considered exclusion if treatment plan includes implant of a TBE device).
12. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
13. Coronary malperfusion.
14. Catastrophic neurological complications in the 30 days prior to the dissection diagnosis (e.g., progressively worsening symptoms, coma, Glasgow Coma Scale <=8).
15. Aortic fistula.
16. In circulatory shock (e.g., systolic blood pressure <80 mmHg without inotropes, base deficit > -10 mmol/L or -10 mEq/L) at any time prior to the initiation of the index endovascular procedure.
17. In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at any time prior to the initiation of the index endovascular procedure.
18. Clinical or radiographic signs of bowel infarction, gastrointestinal hemorrhage, or bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, low pH, and/or acidosis) at any time prior to the initiation of the index endovascular procedure.

Inclusion Criteria - Secondary Arm

The subject is/has:

1. De novo Type A aortic dissection (≤90 days from symptom onset until first study procedure) compatible with the treatment requirements of the ASG device alone or the ASG device in combination with the TBE device in the Zone 0 position.
2. Primarily intended to be treated by placement of the ASG device in the ascending aorta or ASG device in combination with the TBE device in the ascending aorta and aortic arch. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator.

3. Anatomic requirements for intended treatment with the ASG device alone or in combination with the TBE device.

   a) Anatomic compatibility required for implanting the ASG device (Intended treatment with ASG device alone) i. Proximal Aortic Landing Zone:

   1. Primary entry tear must be in the ascending aorta and ≥ 2 cm distal to the most distal coronary artery ostium.
   2. Total aortic diameter between 27mm - 48mm.
   3. Landing zone cannot be heavily calcified or thrombosed. ii. Distal Aortic Landing Zone:

   1. Primary entry tear must be in the ascending aorta and ≥ 2 cm proximal to BCA ostium.

      iii. Adequate aortic length

   2. Anatomic compatibility required for implanting the ASG device (Intended treatment with ASG device and TBE device) i. Proximal Aortic Landing Zone:
   1. Primary entry tear must be identified in Zone 0-5.
   2. Landing zone is native aorta.
   3. Primary entry tear location is ≥2cm distal to the most distal coronary artery ostium.
   4. Proximal landing zone must be ≥2cm in the ascending aorta.
   5. Landing zone cannot be heavily calcified or thrombosed.
   6. Total aortic landing zone diameter 27mm - 48mm. ii. Branch Vessel Landing Zone:
   1. Length of ≥2.5 cm proximal to first major branch vessel.
   2. Target branch vessel inner diameters of 11-18 mm.
   3. Target branch vessel landing zone must be in native vessel that cannot be heavily calcified or thrombosed.
   4. The distal 15mm landing zone cannot be dissected.

4. 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:

   1. ≥80 years of age
   2. BMI ≥ 35 kg/m2
   3. History of Respiratory Insufficiency (defined by home O2 usage, exertional dyspnea, imaging evidence of COPD, previous evidence of compromised PFTs on spirometry or other factors as determined by the Investigator)
   4. Prior Cardiac Surgery
   5. Hostile Chest (VARC-2 Definition)
   6. Clinical Frailty Scale 3-9
   7. Clinical malperfusion (head, gut, lower extremity)
   8. Transfusion is not possible (e.g., Jehovah's Witness)
   9. Renal Dialysis prior to aortic dissection
   10. Chronic renal insufficiency (eGFR<60 without dialysis or other documented history of chronic kidney disease prior to dissection)
5. Age ≥18 years at time of informed consent signature.
6. Adequate vascular access via transfemoral or retroperitoneal approach.
7. Informed Consent Form (ICF) signed by the subject or legally authorized representative.
8. Agrees to comply with protocol requirements, including imaging and 5-year follow-up, as the subject's condition allows.

Exclusion Criteria - Secondary Arm:

The subject is/has:

1. Mechanical heart valve in the aortic position.
2. Pregnant at time of procedure.
3. Active infected aorta, mycotic aneurysm.
4. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).
5. Known sensitivities or allergies to the device materials (Previous instance of Heparin Induced Thrombocytopenia type 2 [HIT-2], known hypersensitivity to heparin, or a history of a hypercoagulability disorder and/or state should be considered exclusion if treatment plan includes implant of a TBE device).
6. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary; 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); Endovascular aortic repair of the ascending aorta
Experimental: Secondary; 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); Endovascular aortic repair of the ascending aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	Procedural Success Treatment Success Primary Technical Success (Unassisted) SF-36® Physical Component Summary measured at one year follow-up	1 Year

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Eric Roselli, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: ASG 24-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes