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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • GORE® Ascending Stent Graft (ASG device)

    Device

    Endovascular aortic repair of the ascending aorta

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: PrimaryExperimental treatment 1 intervention
Group B: SecondaryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 Days
2

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

Time frame
30 Days

Secondary outcomes

1

Secondary Endpoint

Procedural Success Treatment Success Primary Technical Success (Unassisted) SF-36® Physical Component Summary measured at one year follow-up

Time frame
1 Year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

W.L.Gore & Associates

Lead sponsor

Source ClinicalTrials.gov
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