GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
ConditionAortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorW.L.Gore & Associates
About this trial
To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
Eligibility criteria
Qualifiers
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.
≥80 years of age
Body mass index (BMI) ≥ 35 kg/m2
Disqualifiers
Primary Arm
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).
Trial design
Treatments tested in this trial
- GORE® Ascending Stent Graft (ASG device)
Treatment groups
112 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov