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

Official title

Effectiveness and Safety of a Type A Dissection Total Endovascular REconstruction System in Promoting Favorable Distal AOrtic ReModeling After Total Arch Replacement With Frozen Elephant Trunk for Type A Aortic Dissection: A Prospective, Multicenter, Randomized Controlled Trial

Overview

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.

Interventions

• Device surgical treatment
  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)
  Standard medical therapy (e.g., blood pressure and heart rate control)

Primary outcome measures

• Change in False Lumen Volume of the Distal Aortic Dissection at 12 months [Time frame: 12 months (±30 days) post-enrollment]
• The incidence of major adverse events (MAEs) within 30 days [Time frame: 30 days (±7 days) after enrollment]

Secondary outcome measures (12)

• Procedure Success Rate (%) (Immediate post-procedure) (Study Group only) [Time frame: Immediately post procedure]
• Treatment Success Rate (%) (12 months) (Study Group only) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]
• Thrombosis Status of the False Lumen in the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years) [Time frame: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]
• Rate of Secondary Intervention Related to the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years) [Time frame: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.]
• Survival Rate (6, 12 months, 2-5 years) [Time frame: 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]
• Incidence of MAE (6, 12 months, 2-5 years) [Time frame: 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]
• Incidence of Paraplegia/Spinal Cord Ischemia (at 30 days, 6, 12 months, 2-5 years) [Time frame: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.]
• Incidence of Acute Kidney Injury (at 30 days, 6, 12 months, 2-5 years) [Time frame: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.]
• Incidence of Stroke (at 30 days, 6, 12 months, 2-5 years) [Time frame: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]

Eligibility criteria

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.

Exclusion criteria

• 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.
• Subjects deemed unsuitable for participating the study by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT07402252 · CX2025001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗