Type A Aortic DissectionNCT05751200
Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ )
An observational study of Type A Aortic Dissection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This is a retrospective study based on the data available in our hospital database for ATAAD patients from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type A Aortic Dissection
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 2 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study enrolled patients who were diagnosed with ATAAD by computed tomography angiography (CTA) from January 2020 to December 2021 in the First Affiliated Hospital of Xi'an Jiaotong University. Inclusion criteria included mild to moderate aortic root involvement, combined with aortic arch involvement undergoing Sun's procedure. The exclusion criteria included severe aortic root involvement (root diameter >45 mm, root tear, severe disruption of aortic root, concomitant valve disease); the Bentall, Wheat or David procedure performed; recurrent ATAAD; preoperative severe brain complications (cerebral infarction, cerebral hemorrhage, coma, etc.), mal-perfusion of abdominal organs or lower extremities >12 h and incomplete clinical data.
Who may be able to join
- Diagnosed with ATAAD by computed tomography angiography (CTA) from January 2020 to December 2021 in the First Affiliated Hospital of Xi'an Jiaotong University
- Mild to moderate aortic root involvement
- Aortic arch involvement undergoing Sun's procedure
Who cannot join
- Patients with severe aortic root involvement (root diameter >45 mm, root tear, severe disruption of aortic root, concomitant valve disease)
- The Bentall, Wheat or David procedure performed
- Recurrent ATAAD
- Preoperative severe brain complications (cerebral infarction, cerebral hemorrhage, coma, etc.)
- Mal-perfusion of abdominal organs or lower extremities >12 h
- Incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ ): an Investigator-initiated, Single-center, Cohort Study
This is a retrospective study based on the data available in our hospital database for ATAAD patients from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.
Read the detailed description
Acute type A aortic dissection (ATAAD) is a life-threatening disease with high mortality. Surgery remains the gold standard for the treatment of ATAAD. In recent years, ATAAD is still a persistent challenge for cardiovascular surgeons. This is a retrospective study based on the data available in our hospital database for ATAAD patients undergoing total aortic arch replacement with elephant trunk stent under cryogenic stop circulation from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root: continuous aortic root suture group (CARS group); "aortic root reinforcement combined with vascular grafts eversion and built-in", which was created by our group and to be named as XJ-procedure (XJ-procedure group, XJ is an acronym for Xi'an Jiaotong University). The main outcome was defined as 30-day mortality. Secondary outcomes included the postoperative bleeding necessitating re-operation and the incidence of anastomotic pseudoaneurysm, residual aortic root dissection and severe aortic regurgitation before discharge and at 3 and 6 months after the operation. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.
- Conditions
- Type A Aortic Dissection
- Being tested
- No Intervention.
- Keywords
- Type A Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention.Other
No Intervention.
| Study group | Role | What they receive |
|---|---|---|
| CARS group | In the CARS group, 3-0 polypropylene was used to suture the proximal end of aortic with the vascular grafts continuously, followed by one interrupted suture loop of 3-0 polypropylene for reinforcement. Receives: Other: No Intervention. | |
| XJ-procedure group | In the XJ-procedure group, a 1.5-2cm wide bovine pericardial patch and graft ring were 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 was intermittently sutured to full layers of aortic vascular with 2-0 pad polyester sutures. Finally, the eversion and aortic wall were continuously sutured together in one more turn. Receives: Other: No Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Patients died within 30 days after the surgery. Data were obtained from the medical records.
Measured: Within 30 days after the surgery
Secondary outcomes (4)
The postoperative bleeding necessitating re-operation
Postoperative bleeding necessitated reoperation during hospitalization. Data were obtained from the surgical records and medical records.
Measured: About 2 weeks after the surgery.
Change in the incidence of anastomotic pseudoaneurysm
The occurrence of anastomotic pseudoaneurysm was examined by postoperative computed tomography angiography examination.
Measured: About 2 weeks after surgery, 3-month and 6-month follow-up.
Change in the incidence of residual aortic root dissection
The occurrence of residual aortic dissection was examined by postoperative computed tomography angiography examination.
Measured: About 2 weeks after surgery, 3-month and 6-month follow-up.
Change in the incidence of severe aortic regurgitation
The occurrence of aortic valve regurgitation greater than grade2+, which was decided by cardiac ultrasonography.
Measured: About 2 weeks after surgery, 3-month and 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Mar 2023
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751200
- Sponsor's protocol ID
- XJTU1AF2023LSK-150
- Status last verified
- Aug 2023
- First submitted
- 14 Feb 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Zhao C, Li B, Yan P, Zhang Y, Li Y, Wang Q, He X, Zheng X, Yan Y. Aortic Root Reinforcement Combined with Vascular Grafts Eversion and Built-in Procedure (XJ-Procedure) for Acute Type A Aortic Dissection Surgery. Adv Ther. 2023 Dec;40(12):5354-5365. doi: 10.1007/s12325-023-02655-2. Epub 2023 Oct 4.
PubMed 37789228
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ ): an Investigator-initiated, Single-center, Cohort Study
- ClinicalTrials.gov ID
- NCT05751200
- Acronym / sponsor ID
- XJTU1AF2023LSK-150
- Conditions
- Type A Aortic Dissection
- Keywords
- Type A Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 2 Mar 2023 (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 retrospective study based on the data available in our hospital database for ATAAD patients from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.
Detailed description
Acute type A aortic dissection (ATAAD) is a life-threatening disease with high mortality. Surgery remains the gold standard for the treatment of ATAAD. In recent years, ATAAD is still a persistent challenge for cardiovascular surgeons. This is a retrospective study based on the data available in our hospital database for ATAAD patients undergoing total aortic arch replacement with elephant trunk stent under cryogenic stop circulation from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root: continuous aortic root suture group (CARS group); "aortic root reinforcement combined with vascular grafts eversion and built-in", which was created by our group and to be named as XJ-procedure (XJ-procedure group, XJ is an acronym for Xi'an Jiaotong University). The main outcome was defined as 30-day mortality. Secondary outcomes included the postoperative bleeding necessitating re-operation and the incidence of anastomotic pseudoaneurysm, residual aortic root dissection and severe aortic regurgitation before discharge and at 3 and 6 months after the operation. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARS group | – | Other: No Intervention.In the CARS group, 3-0 polypropylene was used to suture the proximal end of aortic with the vascular grafts continuously, followed by one interrupted suture loop of 3-0 polypropylene for reinforcement. |
| XJ-procedure group | – | Other: No Intervention.In the XJ-procedure group, a 1.5-2cm wide bovine pericardial patch and graft ring were 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 was intermittently sutured to full layers of aortic vascular with 2-0 pad polyester sutures. Finally, the eversion and aortic wall were continuously sutured together in one more turn. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study enrolled patients who were diagnosed with ATAAD by computed tomography angiography (CTA) from January 2020 to December 2021 in the First Affiliated Hospital of Xi'an Jiaotong University. Inclusion criteria included mild to moderate aortic root involvement, combined with aortic arch involvement undergoing Sun's procedure. The exclusion criteria included severe aortic root involvement (root diameter >45 mm, root tear, severe disruption of aortic root, concomitant valve disease); the Bentall, Wheat or David procedure performed; recurrent ATAAD; preoperative severe brain complications (cerebral infarction, cerebral hemorrhage, coma, etc.), mal-perfusion of abdominal organs or lower extremities >12 h and incomplete clinical data.
Key inclusion criteria (3 listed)
- Diagnosed with ATAAD by computed tomography angiography (CTA) from January 2020 to December 2021 in the First Affiliated Hospital of Xi'an Jiaotong University
- Mild to moderate aortic root involvement
- Aortic arch involvement undergoing Sun's procedure
Key exclusion criteria (6 listed)
- Patients with severe aortic root involvement (root diameter >45 mm, root tear, severe disruption of aortic root, concomitant valve disease)
- The Bentall, Wheat or David procedure performed
- Recurrent ATAAD
- Preoperative severe brain complications (cerebral infarction, cerebral hemorrhage, coma, etc.)
- Mal-perfusion of abdominal organs or lower extremities >12 h
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 |
|---|---|---|
| No Intervention.No Intervention. | Other | CARS group, XJ-procedure group |
Primary outcome
30-day mortality
Time frame: Within 30 days after the surgery
Patients died within 30 days after the surgery. Data were obtained from the medical records.
4 secondary outcomes
The postoperative bleeding necessitating re-operation
Time frame: About 2 weeks after the surgery.
Change in the incidence of anastomotic pseudoaneurysm
Time frame: About 2 weeks after surgery, 3-month and 6-month follow-up.
Change in the incidence of residual aortic root dissection
Time frame: About 2 weeks after surgery, 3-month and 6-month follow-up.
Change in the incidence of severe aortic regurgitation
Time frame: About 2 weeks after surgery, 3-month and 6-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Derived from this study: PubMed 37789228Li J, Zhao C, Li B, Yan P, Zhang Y, Li Y, Wang Q, He X, Zheng X, Yan Y. Aortic Root Reinforcement Combined with Vascular Grafts Eversion and Built-in Procedure (XJ-Procedure) for Acute Type A Aortic Dissection Surgery. Adv Ther. 2023 Dec;40(12):5354-5365. doi: 10.1007/s12325-023-02655-2. Epub 2023 Oct 4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yang Yan 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?
An observational study of Type A Aortic Dissection, 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 9 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: Within 30 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05751200, which also lists 1 linked publication.
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 9 Aug 2023.