RecruitingNot Applicable

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

United States112 participantsStarted 2025-09-22

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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

✕. 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.

Primary Safety Endpoint

Timeframe: 30 Days

Primary Effectiveness Endpoint

Timeframe: 30 Days

NCT IDNCT06827990

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-09-01

Clinical Study Manager

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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

✕. 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.