Aortic Dissection AneurysmNCT06256757
Safety and Validity of Extracorporeal Fenestration and in Situ Fenestration in Patients With Aortic Disease Involving the Left Subclavian Artery
A study testing fenestration in people with Aortic Dissection Aneurysm, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection Aneurysm
- What is being tested?
- fenestration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Apr 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:(All of the following criteria were met for enrolment):
- Patients aged greater than 18 years old and less than 80 years old.
- Patients diagnosed with thoracic aortic disease, including thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic ulcer and intramural hematoma.
- Patients needed endovascular repair (TEVER).
- Patients who needed complete coverage of the left subclavian artery (planned landing Zone was in Zone 2 of the aortic zone).
- The proximal lesion involved the proximal aorta within 1.5cm of the posterior edge of the left subclavian artery (LSA) opening, but not the left common carotid artery (LCCA).
- Suitable femoral artery, iliac artery and brachial artery access can be used for endovascular treatment.
- The patients could understand the purpose of the study, volunteered to participate in the study, and informed consent was signed by the subjects themselves or their legal representatives.
- Patients were willing to undergo follow-up evaluation as required by the study protocol.
- The life expectancy of the patient is more than 12 months.
Exclusion Criteria:(If any of the following criteria is met):
- The lesion involved the proximal aorta of the LCCA opening (Zone 0 and Zone 1).
- The patient has a definite connective tissue disease (e.g., Marfan syndrome).
- The subjects had a history of previous thoracic endovascular aortic repair (TEVAR).
- Patients who have had or may have had severe allergic reactions to contrast media (anaphylactic shock, exfoliative dermatitis, etc.).
- Patients with contraindications to antiplatelet and anticoagulant drugs.
- The patient's compliance was poor and the follow-up could not be expected on time.
- Patients with acute systemic infection.
- Patients cannot tolerate general anesthesia.
- Patients judged by the investigator to be ineligible for endovascular treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.
- Conditions
- Aortic Dissection Aneurysm
- Being tested
- fenestration
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenestrationProcedure or surgery
Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations
| Study group | Role | What they receive |
|---|---|---|
| A（extracorporeal fenestration） | Experimental | Based on the preoperative CTA reconstructions, the diameter of the aorta and branch vessels, lengths, angles to the arch, clock positions, and related relationships are measured, and a preoperative design for the fenestrations is developed. The outer sheath of the stent graft is then pushed back for several centimeters under sterile conditions, allowing the proximal portion of the stent graft to be released. The length of the released segment should be one to two centimeters distal from the location of fenestration. Using a sterile ruler, the location of the fenestration is determined in accordance with the preoperative plan. The 12 o'clock position is considered to be at the front of the trigger. The position of the stent graft relative to the trigger is also referred to as the 12 o'clock position. If the fenestration must avoid stent struts, then the fenestration is deemed to be at 12 o'clock, as is the position of the trigger relative to the stent graft. Receives: Procedure: fenestration |
| B（In situ fenestration） | Sham comparator | From the left brachial artery (LBA), a 6F angle-adjustable sheath (Lifetech, Inc., Shenzhen, China) is introduced retrogradely until its tip reaches the aortic stent graft. The tip is then adjusted to be as perpendicular as possible to the larger curve of the aortic stent graft. Once the sheath gets to the ideal position, a flexible needle (21 gauge, Futhrough, Lifetech, Inc.) is employed to create the fenestration in the aortic stent graft. Following the puncture, a 0.018-inch guidewire (V-18 ControlWire; Boston Scientific, Natick, MA) is inserted through the needle aperture and into the ascending aorta. Receives: Procedure: fenestration |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
all-cause mortality
Measured: 1 month postoperative
Secondary outcomes (5)
incidence of endoleak
incidence of endoleak
Measured: postoperative (1, 6，12 months)
incidence of secondary intervention
incidence of secondary intervention
Measured: postoperative (1, 6，12 months)
incidence of major adverse events (MAE)
incidence of major adverse events (MAE)
Measured: postoperative (1, 6，12 months)
immediate technical success rate
immediate technical success rate
Measured: immediate postoperative
all-cause mortality
all-cause mortality
Measured: postoperative (6, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 May 2024 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Apr 2029 (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 Aortic Dissection AneurysmStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanbo Lou, Study director, The Fourth Affiliated Hospital Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256757
- Sponsor's protocol ID
- K2024031
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request, the corresponding author will provide access to the full protocol, participant level-data and statistical code
Publications
Jia X, Wu J, Ding C, Lou Y. Safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery: a prospective, single-center, randomized controlled study. Trials. 2025 Jan 30;26(1):33. doi: 10.1186/s13063-025-08746-5.
PubMed 39885531
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Validity of Extracorporeal Fenestration and in Situ Fenestration in Patients With Aortic Disease Involving the Left Subclavian Artery
- ClinicalTrials.gov ID
- NCT06256757
- Acronym / sponsor ID
- K2024031
- Conditions
- Aortic Dissection Aneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 13 Feb 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 trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A（extracorporeal fenestration） | Experimental | Procedure: fenestrationBased on the preoperative CTA reconstructions, the diameter of the aorta and branch vessels, lengths, angles to the arch, clock positions, and related relationships are measured, and a preoperative design for the fenestrations is developed. The outer sheath of the stent graft is then pushed back for several centimeters under sterile conditions, allowing the proximal portion of the stent graft to be released. The length of the released segment should be one to two centimeters distal from the location of fenestration. Using a sterile ruler, the location of the fenestration is determined in accordance with the preoperative plan. The 12 o'clock position is considered to be at the front of the trigger. The position of the stent graft relative to the trigger is also referred to as the 12 o'clock position. If the fenestration must avoid stent struts, then the fenestration is deemed to be at 12 o'clock, as is the position of the trigger relative to the stent graft. |
| B（In situ fenestration） | Sham comparator | Procedure: fenestrationFrom the left brachial artery (LBA), a 6F angle-adjustable sheath (Lifetech, Inc., Shenzhen, China) is introduced retrogradely until its tip reaches the aortic stent graft. The tip is then adjusted to be as perpendicular as possible to the larger curve of the aortic stent graft. Once the sheath gets to the ideal position, a flexible needle (21 gauge, Futhrough, Lifetech, Inc.) is employed to create the fenestration in the aortic stent graft. Following the puncture, a 0.018-inch guidewire (V-18 ControlWire; Boston Scientific, Natick, MA) is inserted through the needle aperture and into the ascending aorta. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| fenestrationThoracic EndoVascular Aortic Repair (TEVAR) with fenestrations | Procedure or surgery | A（extracorporeal fenestration）, B（In situ fenestration） |
Primary outcome
all-cause mortality
Time frame: 1 month postoperative
all-cause mortality
5 secondary outcomes
incidence of endoleak
Time frame: postoperative (1, 6，12 months)
incidence of secondary intervention
Time frame: postoperative (1, 6，12 months)
incidence of major adverse events (MAE)
Time frame: postoperative (1, 6，12 months)
immediate technical success rate
Time frame: immediate postoperative
all-cause mortality
Time frame: postoperative (6, 12 months)
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 13 Feb 2024.
- Derived from this study: PubMed 39885531Jia X, Wu J, Ding C, Lou Y. Safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery: a prospective, single-center, randomized controlled study. Trials. 2025 Jan 30;26(1):33. doi: 10.1186/s13063-025-08746-5.
- Individual participant dataSharing planned: No. Upon reasonable request, the corresponding author will provide access to the full protocol, participant level-data and statistical code
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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.
Yanbo Lou study director
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing fenestration in people with Aortic Dissection Aneurysm, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Feb 2024. 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. Some participants in this study may receive a placebo. 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 Yanbo Lou (15088201610, yanbo_lou@zju.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: 1 month postoperative). 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 NCT06256757, 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 13 Feb 2024.