Ascending Aortic DissectionNCT04544579
Endovascular Graft Anchoring Different Regions of Ascending Aorta in the Treatment of Ascending Aortic Dissection
An observational study of Ascending Aortic Dissection, run by Chinese Medical Association.
Trial summary
Aortic dissection is a deadly and dangerous disease. About 28% of patients with ascending aortic dissection can't tolerate open surgical trauma caused by thoracotomy and cardiopulmonary bypass, and the prognosis is poor. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ascending Aortic Dissection
- What is being tested?
- Stent grafts anchored in different areas
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This clinical trial included a prospective study of patients admitted to the hospital with aortic dissection between October 2020 and September 2023 who were treated with an endoluminal graft after exclusion of surgical contraindications.
Who may be able to join
- Aortic dissection diagnosed by CTA;
- With indications for endovascular treatment
- The luminal graft anchor is required to be located in the ascending aorta.
Who cannot join
- Import difficult, such as external iliac artery diameter is less than 6 mm bilateral iliac, artery stenosis distortions;
- Patients with severe comorbidities, such as severe myocardial insufficient blood supply, heart failure, arrhythmia, severe renal dysfunction, and severe blood coagulation dysfunction;
- Patients with malignant tumor, or other serious illness, life expectancy of less than 1 year；
- Puncture local infection and high fever;⑤ within 1 month of the large area;
- Contrast media in patients with cerebrovascular accident or digestive tract hemorrhage patients with allergies;
- Aortic ulcer or aortic wall hematoma and other atypical dissection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endovascular Graft Anchoring Different Regions of Ascending Aorta in the Treatment of Ascending Aortic Dissection: a Prospective， Controlled and Multicenter Study
Aortic dissection is a deadly and dangerous disease. About 28% of patients with ascending aortic dissection can't tolerate open surgical trauma caused by thoracotomy and cardiopulmonary bypass, and the prognosis is poor. Minimally invasive endovascular treatment has been applied in the treatment of descending aortic dissection. However, due to the special anatomical structure and high speed /pressure blood flow, the treatment of ascending aorta dissection has become an international difficulty.
Read the detailed description
This study was designed combination of retrospective and prospective methods, and focused on distal false lumen Aneurysmal Expansion of Aortic Dissection (DAEAD) . To formulate clinical data for the risk assessment of DAEAD, and best intracavitary treatment or long-term efficacy evaluation, we combined the results of genetic testing, evaluating the missense mutation, computer simulation of blood flow dynamics analysis, and clinical imaging analysis.
- Conditions
- Ascending Aortic Dissection
- Being tested
- Stent grafts anchored in different areas
- Medical subject headings
- Dissection, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent grafts anchored in different areasDevice
Endovascular repair of ascending aortic dissection patients with stent grafts anchored in different areas
| Study group | Role | What they receive |
|---|---|---|
| Ascending aortic dissection patients | Ascending aortic dissection patients Receives: Device: Stent grafts anchored in different areas |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of operation
The operation was completed successfully without complications.
Measured: before December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
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 Ascending Aortic DissectionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Collaborators
- Changhai Hospital
- Responsible party
- Principal investigator, Zaiping Jing, Chinese Medical Association
- Investigators
- Zaiping Jing, Professor, Principal investigator, Vascular surgery, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544579
- Sponsor's protocol ID
- https://orcid.org/0000-0002-07
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pei Y, Zhu H, Xiao Y, Zhou J, Jing Z. The Mini-Cross Prefenestration for Endovascular Repair of Aortic Arch Pathologies. Front Cardiovasc Med. 2022 Jan 11;8:745871. doi: 10.3389/fcvm.2021.745871. eCollection 2021.
PubMed 35087876
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Graft Anchoring Different Regions of Ascending Aorta in the Treatment of Ascending Aortic Dissection: a Prospective， Controlled and Multicenter Study
- ClinicalTrials.gov ID
- NCT04544579
- Acronym / sponsor ID
- https://orcid.org/0000-0002-07
- Conditions
- Ascending Aortic Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Collaborators
- Changhai Hospital
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 10 Sep 2020 (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.
Aortic dissection is a deadly and dangerous disease. About 28% of patients with ascending aortic dissection can't tolerate open surgical trauma caused by thoracotomy and cardiopulmonary bypass, and the prognosis is poor. Minimally invasive endovascular treatment has been applied in the treatment of descending aortic dissection. However, due to the special anatomical structure and high speed /pressure blood flow, the treatment of ascending aorta dissection has become an international difficulty.
Detailed description
This study was designed combination of retrospective and prospective methods, and focused on distal false lumen Aneurysmal Expansion of Aortic Dissection (DAEAD) . To formulate clinical data for the risk assessment of DAEAD, and best intracavitary treatment or long-term efficacy evaluation, we combined the results of genetic testing, evaluating the missense mutation, computer simulation of blood flow dynamics analysis, and clinical imaging analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascending aortic dissection patients | – | Device: Stent grafts anchored in different areasAscending aortic dissection patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical trial included a prospective study of patients admitted to the hospital with aortic dissection between October 2020 and September 2023 who were treated with an endoluminal graft after exclusion of surgical contraindications.
Key inclusion criteria (3 listed)
- Aortic dissection diagnosed by CTA;
- With indications for endovascular treatment
- The luminal graft anchor is required to be located in the ascending aorta.
Key exclusion criteria (6 listed)
- Import difficult, such as external iliac artery diameter is less than 6 mm bilateral iliac, artery stenosis distortions;
- Patients with severe comorbidities, such as severe myocardial insufficient blood supply, heart failure, arrhythmia, severe renal dysfunction, and severe blood coagulation dysfunction;
- Patients with malignant tumor, or other serious illness, life expectancy of less than 1 year；
- Puncture local infection and high fever;⑤ within 1 month of the large area;
- Contrast media in patients with cerebrovascular accident or digestive tract hemorrhage patients with allergies;
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 |
|---|---|---|
| Stent grafts anchored in different areasEndovascular repair of ascending aortic dissection patients with stent grafts anchored in different areas | Device | Ascending aortic dissection patients |
Primary outcome
success of operation
Time frame: before December 2022
The operation was completed successfully without complications.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Derived from this study: PubMed 35087876Pei Y, Zhu H, Xiao Y, Zhou J, Jing Z. The Mini-Cross Prefenestration for Endovascular Repair of Aortic Arch Pathologies. Front Cardiovasc Med. 2022 Jan 11;8:745871. doi: 10.3389/fcvm.2021.745871. eCollection 2021.
Related trials for Ascending Aortic Dissection
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PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
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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.
Zaiping Jing, Professor principal investigator
Vascular surgery, Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ascending Aortic Dissection, run by Chinese Medical Association.
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: status not confirmed, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zaiping Jing, professor (02131161670, xueguanky@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of operation (time frame: before December 2022). 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 NCT04544579, 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 10 Sep 2020.