Effectiveness and Safety of a Type A Dissection Total Endovascular Reconstruction System in Promoting Favorable Distal Aortic Remodeling (REFORM-TAD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Residual Dissection After Repair for Type A Aortic Dissection
• Intervention / Treatment: Device: surgical treatment; Drug: Standard of Care (Investigator Choice)

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia Hu; Phone Number: +86 18682560211; Email: jiahu@wchscu.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
      • Contact: Jia Hu; Phone Number: +86 18682560211; Email: jiahu@wchscu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Group; 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; 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)
Active Comparator: Control Group; 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); Standard medical therapy (e.g., blood pressure and heart rate control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Through study completion, an average of 5 year

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 9, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; Surgical Procedures, Operative
• Other Study ID Numbers: CX2025001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No