Residual Dissection After Repair for Type A Aortic DissectionREFORM-TADNCT07402252
Effectiveness and Safety of a Type A Dissection Total Endovascular Reconstruction System in Promoting Favorable Distal Aortic Remodeling
A study testing surgical treatment in people with Residual Dissection After Repair for Type A Aortic Dissection, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Dissection After Repair for Type A Aortic Dissection
- What is being tested?
- surgical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital of Sichuan University
Chengdu, Sichuan
Jia Hu, +86 18682560211, jiahu@wchscu.edu.cn
About this study
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
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.
- Being tested
- surgical treatment, Standard of Care (Investigator Choice)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatmentDevice
Endovascular repair with study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection.
Standard of Care (Investigator Choice)Drug
Standard medical therapy (e.g., blood pressure and heart rate control)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 30 days (±7 days) after enrollment
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start9 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual Dissection After Repair for Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Hu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402252
- Sponsor's protocol ID
- CX2025001
- Acronym
- REFORM-TAD
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07402252
- Acronym / sponsor ID
- REFORM-TAD / CX2025001
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Device: surgical treatment, Drug: Standard of Care (Investigator Choice)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. |
| Control Group | Active comparator | Drug: Standard of Care (Investigator Choice)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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):
- Voluntarily participate in this study and provide signed informed consent.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical treatmentEndovascular repair with study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection. | Device | Study Group |
| Standard of Care (Investigator Choice)Standard medical therapy (e.g., blood pressure and heart rate control) | Drug | Control Group, Study Group |
Primary outcome
Change in False Lumen Volume of the Distal Aortic Dissection at 12 months
Time frame: 12 months (±30 days) post-enrollment
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
The incidence of major adverse events (MAEs) within 30 days
Time frame: 30 days (±7 days) after enrollment
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.
15 secondary outcomes
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
Incidence of Stent Migration (at 30 days, 6, 12 months) (Study Group only)
Time frame: 30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) after enrollment.
Incidence of AE/SAEs
Time frame: Through study completion, an average of 5 year
Incidence of Device Deficiencies (Study Group only)
Time frame: Through study completion, an average of 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical treatment in people with Residual Dissection After Repair for Type A Aortic Dissection, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Hu (+86 18682560211, jiahu@wchscu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in False Lumen Volume of the Distal Aortic Dissection at 12 months (time frame: 12 months (±30 days) post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.