Type A Aortic DissectionADVANCED-XJ-ⅡNCT06199401
Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery
A study testing Vascular Grafts Eversion and Built-in Technique(XJ-Procedure) in people with Type A Aortic Dissection and Complication of Surgical Procedure, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This is a national, multicenter, open-label, randomized, controlled, endpoint-blinded clinical trial of patients diagnosed with ATAAD and undergoing "Sun's procedure" coordinated by the First Affiliated Hospital of Xi'an Jiaotong University, China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type A Aortic Dissection, Complication of Surgical Procedure, Aortic Diseases
- What is being tested?
- Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2024to 1 Dec 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years;
- Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".
Who cannot join
- Severe aortic root involvement (root diameter >45 mm, root tear, severe destruction of the aortic root, combined valve disease);
- Combined coronary artery disease requiring concomitant coronary revascularization;
- Prior aortic or cardiac surgery;
- Preoperative severe malperfusion syndromes such as: severe cerebral complications (acute cerebral infarction, cerebral hemorrhage, coma, etc.); malperfusion of abdominal organs or lower extremities >12 h;
- Preoperative combination of severe single or multiple organ failure;
- Pregnant women;
- Refused to sign the informed consent form and refused to participate in this study.
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, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yang Yan, 0086-18991232621, yangyan3@xjtu.edu.cn
Fengwei Guo, 0086-13991259800, guofengwei@xjtu.edu.cn
About this study
Official title: Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery (ADVANCED-XJ-Ⅱ): A National, Multi-center, Open-label, Randomized, Controlled, Blinded-end Point Trial
This is a national, multicenter, open-label, randomized, controlled, endpoint-blinded clinical trial of patients diagnosed with ATAAD and undergoing "Sun's procedure" coordinated by the First Affiliated Hospital of Xi'an Jiaotong University, China. Per the protocol, "Sun's procedure" combined with "XJ-Procedure" in the anastomosis of the aortic root and Sun's procedure combined with regular suturing methods of the aortic root will be compared.
Read the detailed description
In this study, the investigators will prospectively enroll patients diagnosed with ATAAD and undergo "Sun's procedure" from November 2024 to November 2027 in several centers, including the First Affiliated Hospital of Xi'an Jiaotong University, and will randomly divide them into XJ-procedure group and control group. "The patients in the XJ-procedure group will undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with the XJ-procedure. The patients in the control group will also undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with each center. The primary outcome event is all-cause mortality within 12 months after surgery. Secondary outcome events are (1) incidence of residual aortic root entrapment (during hospitalization, follow-up 3 months, 6 months, 12 months) (2) rate of secondary surgery for hemostasis due to root hemorrhage (during hospitalization) (3) incidence of anastomotic pseudoaneurysm (during hospitalization, follow-up 3 months, 6 months, 12 months) (4) rate of severe regurgitation of residual aortic valves (during hospitalization, follow-up 3 months, 6 months, 12 months) (5) Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) (during hospitalization, follow-up 3 months, 6 months, 12 months).
- Being tested
- Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)
- Keywords
- Type A Aortic Dissection, Aortic Root Reinforcement, Cardiovascular Surgery, Postoperative Complication
- Medical subject headings
- Aortic Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)Procedure or surgery
A 1.5-2cm wide bovine pericardial patch and graft ring will be placed inside and outside the aortic root and against the aortic wall, respectively, and continuously sutured near the commissure using 5-0 polypropylene. Then an eversion about 15mm of vascular graft will be intermittently sutured to full layers of aortic vascular with 2-0 pad polyester suture. Finally, the eversion and aortic wall will be continuously sutured together in one more turn.
| Study group | Role | What they receive |
|---|---|---|
| XJ-Procedure Group | Experimental | In the XJ-Procedure Group, Patients will be performed the standard "Sun's procedure" after general anesthesia, in which the end-to-end anastomosis between the artificial vessel and the aortic root is performed using the "Vascular Grafts Eversion and Built-in Technique" during the aortic root suture. Receives: Procedure: Vascular Grafts Eversion and Built-in Technique(XJ-Procedure) |
| Control Group | No intervention | In the Control Group, Patients will be performed the standard "Sun's procedure" which involves aortic root anastomosis using the regular technique at each cardiovascular surgery center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
This outcome is a time-to-event variable and its data will be obtained at 12 months follow-up, according to the medical records or phone calls of all patients.
Measured: 12 months follow-up
Secondary outcomes (5)
Change of incidence of residual aortic root dissection
The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to CTA and echocardiography results of all patients.
Measured: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Change of incidence of second surgery for hemostasis due to aortic root hemorrhage
The data will be obtained during hospitalization, according to medical records of all patients.
Measured: About 20 days (during hospitalization)
Change of incidence of anastomotic pseudoaneurysms during hospitalization
The data will be obtained during hospitalization at the 3 months, 6 months, and 12 months follow-up, according to CTA and echocardiography results of all patients.
Measured: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Change of incidence of severe residual aortic valve regurgitation
The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to the echocardiography results of all patients.
Measured: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Change of incidence of MACCE
MACCE includes all-cause of death, myocardial infarction, stroke and coronary revascularization. The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to medical records and imaging findings of all patients.
Measured: About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start11 Jan 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Second Affiliated Hospital of Nanchang University, Qinghai People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityGuoliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199401
- Sponsor's protocol ID
- XJTU1AF2023LSYY-006-1
- Acronym
- ADVANCED-XJ-Ⅱ
- Status last verified
- Apr 2024
- First submitted
- 18 Dec 2023
- Last updated
- 12 Jul 2024
- 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 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery (ADVANCED-XJ-Ⅱ): A National, Multi-center, Open-label, Randomized, Controlled, Blinded-end Point Trial
- ClinicalTrials.gov ID
- NCT06199401
- Acronym / sponsor ID
- ADVANCED-XJ-Ⅱ / XJTU1AF2023LSYY-006-1
- Keywords
- Type A Aortic Dissection, Aortic Root Reinforcement, Cardiovascular Surgery, Postoperative Complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Second Affiliated Hospital of Nanchang University, Qinghai People's Hospital
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Jan 2024 (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 national, multicenter, open-label, randomized, controlled, endpoint-blinded clinical trial of patients diagnosed with ATAAD and undergoing "Sun's procedure" coordinated by the First Affiliated Hospital of Xi'an Jiaotong University, China. Per the protocol, "Sun's procedure" combined with "XJ-Procedure" in the anastomosis of the aortic root and Sun's procedure combined with regular suturing methods of the aortic root will be compared.
Detailed description
In this study, the investigators will prospectively enroll patients diagnosed with ATAAD and undergo "Sun's procedure" from November 2024 to November 2027 in several centers, including the First Affiliated Hospital of Xi'an Jiaotong University, and will randomly divide them into XJ-procedure group and control group. "The patients in the XJ-procedure group will undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with the XJ-procedure. The patients in the control group will also undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with each center. The primary outcome event is all-cause mortality within 12 months after surgery. Secondary outcome events are (1) incidence of residual aortic root entrapment (during hospitalization, follow-up 3 months, 6 months, 12 months) (2) rate of secondary surgery for hemostasis due to root hemorrhage (during hospitalization) (3) incidence of anastomotic pseudoaneurysm (during hospitalization, follow-up 3 months, 6 months, 12 months) (4) rate of severe regurgitation of residual aortic valves (during hospitalization, follow-up 3 months, 6 months, 12 months) (5) Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) (during hospitalization, follow-up 3 months, 6 months, 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XJ-Procedure Group | Experimental | Procedure: Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)In the XJ-Procedure Group, Patients will be performed the standard "Sun's procedure" after general anesthesia, in which the end-to-end anastomosis between the artificial vessel and the aortic root is performed using the "Vascular Grafts Eversion and Built-in Technique" during the aortic root suture. |
| Control Group | No intervention | –In the Control Group, Patients will be performed the standard "Sun's procedure" which involves aortic root anastomosis using the regular technique at each cardiovascular surgery center. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-70 years;
- Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".
Key exclusion criteria (7 listed)
- Severe aortic root involvement (root diameter >45 mm, root tear, severe destruction of the aortic root, combined valve disease);
- Combined coronary artery disease requiring concomitant coronary revascularization;
- Prior aortic or cardiac surgery;
- Preoperative severe malperfusion syndromes such as: severe cerebral complications (acute cerebral infarction, cerebral hemorrhage, coma, etc.); malperfusion of abdominal organs or lower extremities >12 h;
- Preoperative combination of severe single or multiple organ failure;
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 |
|---|---|---|
| Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)A 1.5-2cm wide bovine pericardial patch and graft ring will be placed inside and outside the aortic root and against the aortic wall, respectively, and continuously sutured near the commissure using 5-0 polypropylene. Then an eversion about 15mm of vascular graft will be intermittently sutured to full layers of aortic vascular with 2-0 pad polyester suture. Finally, the eversion and aortic wall will be continuously sutured together in one more turn. | Procedure or surgery | XJ-Procedure Group |
Primary outcome
All-cause mortality
Time frame: 12 months follow-up
This outcome is a time-to-event variable and its data will be obtained at 12 months follow-up, according to the medical records or phone calls of all patients.
5 secondary outcomes
Change of incidence of residual aortic root dissection
Time frame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Change of incidence of second surgery for hemostasis due to aortic root hemorrhage
Time frame: About 20 days (during hospitalization)
Change of incidence of anastomotic pseudoaneurysms during hospitalization
Time frame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Change of incidence of severe residual aortic valve regurgitation
Time frame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Change of incidence of MACCE
Time frame: About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up
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 12 Jul 2024.
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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.
Yang Yan principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Guoliang Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Grafts Eversion and Built-in Technique(XJ-Procedure) in people with Type A Aortic Dissection and Complication of Surgical Procedure, run by First Affiliated Hospital Xi'an Jiaotong University 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Jul 2024. 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 Yang Yan (+86.29.85323869, yangyan3@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 12 months follow-up). 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 12 Jul 2024.