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Endovascular repair for thoracic aortic adversed remodeling early after open surgery for type A aortic dissection: a multicenter, randomized controlled trial.

Endovascular repair for thoracic aortic adversed remodeling early after open surgery for type A aortic dissection: a multicenter, randomized controlled trial.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030050
Enrollment
Unknown
Registered
2020-03-11
Start date
2020-02-15
Completion date
Unknown
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adversed thoracic aortic remodeling early after open surgery for Stanford A aortic dissection

Interventions

experimental group:Endovascular repair
control group:No intervention

Sponsors

Department of Cardiovascular Surgery, West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) The patient is between 18 and 80 years old; 2) Patients who were diagnosed with type A aortic dissection within 0-90 days and received sun's surgery 30 days later; 3) The patient did not received endovascular repair; 4) Residual aortic dissection was found at the distal end of the elephant trunk stent, and the false lumen area of the thoracic descending aorta at the end of the stent was > 50% aortic cross section area; 5) The left subclavian artery has been reconstructed; 6) The life expectancy of patients is more than 12 months; 7) Patients can understand the purpose of the experiment, participate in it voluntarily and sign the informed consent; 8) Patients are willing to follow up for evaluation as required by the clinical trial protocol.

Exclusion criteria

Exclusion criteria: 1) Chronic aortic dissection; 2) Patients who do not have appropriate vascular access, are allergic to alloy materials, have severe renal insufficiency or may have a serious reaction to contrast agent and are not suitable for endovascular repair; 3) Myocardial infarction or cerebrovascular accident occurred within 1 month; 4) Patients whom the investigator deems inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
All causes mortality;Reoperation intervention rate;

Secondary

MeasureTime frame
diameter of true lumen (end of elephant trunk stent/diaphragm plane/lower plane of renal artery);diameter of false lumen (end of elephant trunk stent/diaphragm plane/lower plane of renal artery);volume of true lumen;volume of false lumen;Diameter of circular aorta (end of elephant trunk stent/diaphragm plane/lower plane of renal artery);Aortic growth rate;Major adverse cardiovascular events;Spinal cord ischemia;Acute kidney injury;Bowel ischemia;Dissection rupture;Stent graft-induced new entry;Degree of false lumen thrombosis;

Countries

China

Contacts

Public ContactJia Hu

Department of Cardiovascular Surgery, West China Hospital, Sichuan University

1725194@qq.com+86 18682560211

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026