Effectiveness and Safety of a Type A Dissection Total Endovascular Reconstruction System in Promoting Favorable Distal Aortic Remodeling

NCT07402252 | Not Yet Recruiting

• 1 other identifier: CX2025001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Residual Dissection After Repair for Type A Aortic Dissection

Outcome Measures

Primary Outcomes (2)

• Change in False Lumen Volume of the Distal Aortic Dissection at 12 months

  Defined as the difference in the false lumen volume of the distal aortic dissection (distal to the frozen elephant trunk stent, including thrombosis portions) at baseline and 12 months (±30 days) post-enrollment among subjects in the Study group and Control group, respectively

  12 months (±30 days) post-enrollment

• The incidence of major adverse events (MAEs) within 30 days

  The percentage of subjects in the study or control group who experience any MAEs within 30 days (±7 days) after enrollment, relative to the total number of subjects in each group.

  30 days (±7 days) after enrollment

Secondary Outcomes (15)

• Procedure Success Rate (%) (Immediate post-procedure) (Study Group only)

  Immediately post procedure

• Treatment Success Rate (%) (12 months) (Study Group only)

  12 months (±30 days) after enrollment

• Change in True Lumen Volume of the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years)

  30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.

• Change in False Lumen Volume of the Distal Aortic Dissection (at 30 days, 6 months, 2-5 years)

  30 days (±7 days), 6 months (±30 days), and 2-5 years (±30 days) after enrollment

• Change in Maximum Diameter of the Distal Aorta (True + False Lumen) (at 30 days, 6, 12 months, 2-5 years)

  30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment

Study Arms (2)

Study Group

ACTIVE COMPARATOR

Standard medical therapy (e.g., blood pressure and heart rate control) plus endovascular repair with Study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection.

Device: surgical treatment; Drug: Standard of Care (Investigator Choice)

Control Group

ACTIVE COMPARATOR

Standard medical therapy (e.g., blood pressure and heart rate control) without endovascular repair with Study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection.

Drug: Standard of Care (Investigator Choice)

Interventions

surgical treatment DEVICE

Endovascular repair with study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection.

Study Group

Standard of Care (Investigator Choice) DRUG

Standard medical therapy (e.g., blood pressure and heart rate control)

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of a proximal anastomotic leak at the frozen elephant trunk site post open surgery.
• No left subclavian artery revascularization during the open surgery.
• Presence of severe endoleak, or residual dissection expansion ≥55mm, or distal stent graft-induced new entry.
• History of myocardial infarction, or stroke (with clear symptoms/signs and culprit lesion), or bowel ischemia within 1 month prior to the procedure.
• Previous history of descending thoracic or abdominal aortic surgery.
• Lack of suitable vascular access.
• Known allergy to components of the study device (e.g., Nitinol) or contrast agent.
• Renal insufficiency (creatinine \>2.5 times the upper limit of normal) or requiring long-term regular dialysis.
• Severe liver dysfunction (Child-Pugh Class C).
• Active bleeding, coagulation disorders, thrombocytopenia (platelet count \<50×109/L), or refusal of blood transfusion.
• Uncontrolled severe infection and associated sepsis, shock, or multiple organ failure.
• Life expectancy less than 12 months (due to conditions other than aortic dissection).
• Known or suspected connective tissue degenerative disease, or family history of aortic dissection.
• Pregnant or lactating women.
• Concurrent participation in other drug or medical device clinical studies.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Interventions

Surgical Procedures, Operative; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jia Hu

CONTACT

+86 18682560211; jiahu@wchscu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 11, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

CN (1)