NCT07402252 - Effectiveness and Safety of a Type A Dissection Total Endovascular Reconstruction System in Promoting Favorable Distal Aortic Remodeling | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18 years, male or female. 2. 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): 1. Presence of any intimal tear in the residual dissection of the thoracic aorta and the false lumen is not completely thrombosed. 2. 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). 3. False lumen volume in the thoracic aorta distal to the frozen elephant trunk stent graft is \>50% of the total aortic lumen volume. 3. Voluntarily participate in this study and provide signed informed consent. Exclusion Criteria: 1. Presence of a proximal anastomotic leak at the frozen elephant trunk site post open surgery. 2. No left subclavian artery revascularization during the open surgery. 3. Presence of severe endoleak, or residual dissection expansion ≥55mm, or distal stent graft-induced new entry. 4. History of myocardial infarction, or stroke (with clear symptoms/signs and culprit lesion), or bowel ischemia within 1 month prior to the procedure. 5. Previous history of descending thoracic or abdominal aortic surgery. 6. Lack of suitable vascular access. 7. Known allergy to components of the study device (e.g., Nitinol) or contrast agent. 8. Renal insufficiency (creatinine \>2.5 times the upper limit of normal) or requiring long-term regular dialysis. 9. Severe liver dysfunction (Child-Pugh Class C). 10. Active bleeding, coagulation disorders, thrombocytopenia (platelet count \<50×109/L), or refusal of blood transfusion. 11. Uncontrolled severe infection and associated sepsis, shock, or multiple organ failure. 12. Life expectancy less than 12 months (due to conditions other than aortic dissection). 13. Known or suspected connective tissue degenerative disease, or family history of aortic dissection. 14. Pregnant or lactating women. 15. Concurrent participation in other drug or medical device clinical studies. 16. Subjects deemed unsuitable for participating the study by the investigator.

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 30 days (±7 days) after enrollment

Secondary Outcomes

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

The percentage of subjects in the study group who achieved procedure success immediately after procedure out of the total number of subjects in the study group. Procedure success is defined as successful delivery and positioning of the system, accurate deployment of the stent, successful retrieval of the delivery system, no conversion to open surgical thoracotomy during the procedure, subject survival at the end of the procedure, and no Type I or III endoleak on angiography in the covered stent-graft segment.

Time frame: Immediately post procedure

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

The percentage of subjects in the study group who achieved treatment success at 12 months (±30 days) after enrollment out of the total number of subjects in the study group.

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)

The difference in the volume change of the true lumen of distal aortic dissection (distal to the frozen elephant trunk stent, thoracic and abdominal segments) at baseline, 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) post-enrollment among subjects in the Study group and Control group, respectively.

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)

The difference of change in the false lumen volume of distal aortic dissection (distal to the frozen elephant trunk stent, thoracic and abdominal segments, including thrombosis portions) at baseline, 30 days (±7 days), 6 months (±30 days), and 2-5 years (±30 days) post-enrollment among subjects in the Study group and Control group, respectively.

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)

The difference in the maximum diameter change of the entire distal aorta (true lumen + false lumen, distal to the frozen elephant trunk stent, thoracic and abdominal segments) at baseline, 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) ost-enrollment among subjects in the Study group and Control group, respectively.

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)

The qualitative and/or quantitative assessment of thrombosis status in the false lumen of distal aortic dissection (aortic segment from the distal end of the frozen elephant trunk stent to the superior edge of the celiac trunk origin) for subjects in the study or control group at 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) post-enrollment, based on CTA imaging and aortic reconstruction models.

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)

The percentage of subjects in the study or control group who meet the indications for secondary intervention related to distal aortic dissection within 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) post-enrollment, relative to the total number of subjects in each group.

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)

The percentage of subjects in the study or control group with no all-cause death or aortic-related death at 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment, relative to the total number of subjects in each group.

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)

MAEs include any of the following aortic-related events: death, stroke, myocardial infarction, paraplegia/spinal cord ischemia, intestinal ischemia/necrosis requiring intervention, new-onset renal failure requiring replacement therapy, or respiratory failure requiring prolonged mechanical ventilation or reintubation.

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)

The percentage of subjects in the study or control group who develop paraplegia or spinal cord ischemia within 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment, relative to the total number of subjects in each group.

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)

The percentage of subjects in the study or control group who develop acute kidney injury within 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment, relative to the total number of subjects in each group.

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)

The percentage of subjects in the study or control group who experienced a stroke within 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment, relative to the total number of subjects in each group.

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

Incidence of Stent Migration (at 30 days, 6, 12 months) (Study Group only)

The percentage of subjects in the study group with stent displacement within 30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) after enrollment, relative to the total number of subjects in each group.

Time frame: 30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) after enrollment.

Incidence of AE/SAEs

AE refers to any unfavorable medical event occurring during a clinical trial, whether or not related to the study device.

Time frame: Through study completion, an average of 5 year

Incidence of Device Deficiencies (Study Group only)

A device deficiency refers to any unreasonable risk that may endanger human health and safety during normal use of the medical device in a clinical trial, such as label errors, quality issues, malfunctions, etc.

Time frame: Through study completion, an average of 5 year

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts