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

Study of an Investigational Device for Treating Type A Aortic Dissections

J
Joel Corvera, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY   - Patients considered to be at high-risk of open surgical repair for aortic dissection will be identified at each site by the Aortic Treatment Team and contacted about study participation.

 

Detailed description of study

This study is assessing the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.  

Intervention / Treatment
  • DeviceGORE® Ascending Stent Graft (ASG device)

Participants will receive the Study Device and will be involved in teh study for approximately five (5) years from the time of implant procedure.  Participants will be scheduled for follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months after their procedure and have any required tests done.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Aortic Dissection
  • Age: 18 years - 100 years
  • Gender: All

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.
  5. 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)
  6. Age ≥18 years at time of informed consent signature.
  7. Adequate vascular access via transfemoral or retroperitoneal approach.
  8. Informed Consent Form (ICF) signed by the subject or legally authorized representative.
  9. 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.

This study investigates the safety and effectiveness of using an investigational device for treating Type A aortic dissections. Aortic dissection is a serious condition where the inner layer of the aorta tears, causing blood to flow between the layers of the wall of the aorta. This study is specifically for patients who are considered high-risk for open surgical repair.

Participants in the study will receive the investigational device and will have follow-up visits at specific intervals to monitor their condition and the device's effectiveness. These visits will include necessary tests and imaging as part of the study procedures.

  • Who can participate: Adults 18 years and older with Type A aortic dissection, high-risk for open surgical repair, may participate. Key factors include anatomic compatibility for the device and adequate vascular access.
  • Study details: Participants will receive the investigational device and undergo follow-up visits for up to five years. The study involves regular imaging and tests to assess the device's performance.
  • Study timelines: The study will last approximately five years.
Updated on 13 Jan 2026. Study ID: ECRO-WLG-ARISE-III, 27287
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only