Effectiveness and Safety of a Type A Dissection Total Endovascular Reconstruction System in Promo… (NCT07402252) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness and Safety of a Type A Dissection Total Endovascular Reconstruction System in Promoting Favorable Distal Aortic Remodeling
China198 participantsStarted 2026-02-09
Plain-language summary
This is a prospective, multicenter, randomized controlled clinical study. A total of 198 eligible subjects will be enrolled and randomly assigned in a 1:1 ratio to either the Study Group or the Control Group. Subjects in the Study Group will receive surgical treatment using the study device (Type A Dissection Total Endovascular Reconstruction System) in addition to standard medical therapy following the Total Arch Replacement with Frozen Elephant Trunk. Subjects in the Control Group will continue standard medical therapy without surgical treatment using the study device following Total Arch Replacement with Frozen Elephant Trunk. Clinical follow-ups will be conducted at 30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) post-enrollment to evaluate the effectiveness and safety of the study device.
After all subjects complete the 12-month (±30 days) follow-up, a statistical analysis will be performed and the results will be submitted for the study device registration application. Long-term follow-up will continue for 2-5 years post-enrollment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years, male or female.
. Within 90 days of onset of Stanford Type A Aortic Dissection and 30 days post Total Arch Replacement with Frozen Elephant Trunk treatment (assessed via CTA at 30±7 days post open surgery):
. Presence of any intimal tear in the residual dissection of the thoracic aorta and the false lumen is not completely thrombosed.
. The intercostal arteries in the segment of the residual thoracic aortic dissection are primarily supplied by the false lumen (number of intercostal arteries supplied by false/mixed lumen \> number supplied by true lumen; only intercostal arteries filled with contrast agent are considered).
. False lumen volume in the thoracic aorta distal to the frozen elephant trunk stent graft is \>50% of the total aortic lumen volume.
. Voluntarily participate in this study and provide signed informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in False Lumen Volume of the Distal Aortic Dissection at 12 months
Timeframe: 12 months (±30 days) post-enrollment
2
The incidence of major adverse events (MAEs) within 30 days