Aortic DissectionNCT05126446

the Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration

A study testing the Aorta Arch Stent Graft System combined with the Endovascular Needle System in people with Aortic Dissection, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

A prospective, multi-center, single-group target value method to evaluate the safety and effectiveness of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in situ fenestration technology in the treatment of aortic dissection involving the aortic arch Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Aortic Dissection
What is being tested?: the Aorta Arch Stent Graft System combined with the Endovascular Needle System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 25 Jul 2021to 30 Mar 2028
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 (to be selected if all of the following criteria are met)：

18 years old ≤age≤80 years old, no gender limitation;
Diagnosis of aortic dissection and reconstruction of the left subclavian artery;
The main branches and branches of the aortic arch at the lesion site have sufficient anatomical basis:
The diameter range of the near-end anchoring zone of the main body of the fixed mechanism: 21-46mm;
The length of the anchor zone near the principal part of the tunnel is ≥10mm;
The length of the anchor zone of the branching vessel of the convex target is ≥15mm;
The diameter range of the distal anchoring zone of the target branching vessel is 5-18mm.
The patient has adequate surgical access vessels;
Patients who understand the purpose of the study, voluntarily participate in and sign informed consent, and are willing to follow up.

Exclusion Criteria (If one of the following criteria is met, it will not be selected)：

The patient is pregnant or breastfeeding;
The patient had a history of cardiac surgery (congenital heart disease surgery, heart valve surgery, coronary heart disease surgery, thoracic aortic surgery, etc.), which would affect the implementation of this TEVAR surgery;
The patient has been implanted or planned to be implanted with left ventricular auxiliary pump, interventional valve and other instruments, or is planning to undergo coronary intervention surgery, and aortic dissection is expected to affect the function of such instruments or such instruments will affect the operation of aortic dissection;
Patients with severe hematoma on the aortic wall in the proximal anchoring area of the stent;
Marfan syndrome and other connective tissue diseases, arteritis;
Patients with a history of allergy to contrast agents, anesthetics, antiplatelet drugs, anticoagulants, nickel peptide alloys, and polytetrafluoroethylene materials;
Patients with a history of cerebral infarction or myocardial infarction within 3 months before surgery;
Patients with active bleeding and coagulopathy;
Abnormal renal function: patients with preoperative creatinine > 2.5 times the normal upper limit value;
Abnormal liver function: patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the normal upper limit value, or patients with serum total bilirubin (STB) > 2 times the normal upper limit value;
Patients with end-stage diseases with a life expectancy of less than one year;
patients with poor compliance considered by the investigator;
Patients participating in other clinical trials at the same time.

Trial locations and contacts

1 site in 1 country.

China1 site

Xiangya Second Hospital, Central South University
Changsha, Hunan, 410011

Other trials in China

About this study

Official title: The Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration Technology in the Treatment of Aortic Dissection Involving the Aortic Arch

Read the detailed description

Clinical trials using prospective, multi-center, single-group target value design;
120 subjects with aortic dissection requiring partial arch reconstruction will be enrolled in more than 30 centers in China, and they will meet the test enrollment requirements.
CTA examination was performed at baseline, 30 days, 6 months, 12 months, 36 months, and 60 months after surgery to determine the pathological status and the status of postoperative aortic and branch revascularization

Conditions: Aortic Dissection
Being tested: the Aorta Arch Stent Graft System combined with the Endovascular Needle System
Keywords: in situ fenestration, aortic dissection, aortic dissection involving the aortic arch
Medical subject headings: Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

the Aorta Arch Stent Graft System combined with the Endovascular Needle SystemDevice
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with device

Study groups in NCT05126446
Study group	Role	What they receive
aortic dissection involving the aortic arch	Experimental	Aortic dissection involving the aortic arch was diagnosed in patients requiring revascularization of the aortic arch and its branches Receives: Device: the Aorta Arch Stent Graft System combined with the Endovascular Needle System

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery
MAE was defined as death related to aortic dissection, ischemic stroke, and paraplegia within 30 days after surgery
Measured: Within 30 days after procedure
Primary efficacy endpoint of the Aorta Arch Stent Graft System: treatment success at 12 months after surgery
On the basis of successful surgery, the main and branch stents were unobstructed 12 months after surgery, with no internal leakage requiring intervention, no stent displacement (displacement ≤10mm), no new device-related rupture, and no device-induced aortic arch re-operation
Measured: 12 months after procedure
Primary endpoint of the Endovascular Needle System: Immediate surgical success rate of the Endovascular Needle System
Intraoperative DSA, the membrane was successfully broken in situ with the membrane rupture system, and the membrane rupture system was successfully withdrawn
Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 202130 Mar 2028

First posted19 Nov 2021
Study start25 Jul 2021
Primary completion30 Oct 2027 (estimated)
Study completion30 Mar 2028 (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 DissectionStudies of the same condition, open and under way.
More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05126446
Sponsor's protocol ID: LTP86-01
Status last verified: Jul 2024
First submitted: 8 Nov 2021
Last updated: 23 Jul 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Tan Y, Chen W, Li Z, Xu H, Zhao Y, Zhou D, Bai Y, Wang X, Xu T, Zhang Y, Xu J, Shu X. Early Results of a Single-Center Prospective Clinical Trial: In Situ Fenestration System for Aortic Dissection. Vasc Endovascular Surg. 2025 Aug;59(6):600-609. doi: 10.1177/15385744251330013. Epub 2025 Apr 27.
PubMed 40289333

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
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GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
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Metabolic Phenotyping in vEDS
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Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm

All Aortic Dissection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration Technology in the Treatment of Aortic Dissection Involving the Aortic Arch
ClinicalTrials.gov ID: NCT05126446
Acronym / sponsor ID: LTP86-01
Conditions: Aortic Dissection
Keywords: in situ fenestration, aortic dissection, aortic dissection involving the aortic arch
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Jul 2021 (actual)
Primary completion: 30 Oct 2027 (estimated)
Study completion: 30 Mar 2028 (estimated)
First posted: 19 Nov 2021 (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.

Detailed description

Clinical trials using prospective, multi-center, single-group target value design;
120 subjects with aortic dissection requiring partial arch reconstruction will be enrolled in more than 30 centers in China, and they will meet the test enrollment requirements.
CTA examination was performed at baseline, 30 days, 6 months, 12 months, 36 months, and 60 months after surgery to determine the pathological status and the status of postoperative aortic and branch revascularization

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
aortic dissection involving the aortic arch	Experimental	Device: the Aorta Arch Stent Graft System combined with the Endovascular Needle SystemAortic dissection involving the aortic arch was diagnosed in patients requiring revascularization of the aortic arch and its branches

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
the Aorta Arch Stent Graft System combined with the Endovascular Needle SystemPatients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with device	Device	aortic dissection involving the aortic arch

Primary outcome

Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery
Time frame: Within 30 days after procedure
MAE was defined as death related to aortic dissection, ischemic stroke, and paraplegia within 30 days after surgery
Primary efficacy endpoint of the Aorta Arch Stent Graft System: treatment success at 12 months after surgery
Time frame: 12 months after procedure
On the basis of successful surgery, the main and branch stents were unobstructed 12 months after surgery, with no internal leakage requiring intervention, no stent displacement (displacement ≤10mm), no new device-related rupture, and no device-induced aortic arch re-operation
Primary endpoint of the Endovascular Needle System: Immediate surgical success rate of the Endovascular Needle System
Time frame: intraoperative
Intraoperative DSA, the membrane was successfully broken in situ with the membrane rupture system, and the membrane rupture system was successfully withdrawn

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 23 Jul 2024.
Derived from this study: PubMed 40289333Tan Y, Chen W, Li Z, Xu H, Zhao Y, Zhou D, Bai Y, Wang X, Xu T, Zhang Y, Xu J, Shu X. Early Results of a Single-Center Prospective Clinical Trial: In Situ Fenestration System for Aortic Dissection. Vasc Endovascular Surg. 2025 Aug;59(6):600-609. doi: 10.1177/15385744251330013. Epub 2025 Apr 27.

Related trials for Aortic Dissection

Not yet recruitingPhase 2
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm

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.

Chang Shu, Professor principal investigator

Second Xiangya Hospital of Central South 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 the Aorta Arch Stent Graft System combined with the Endovascular Needle System in people with Aortic Dissection, run by Lifetech Scientific (Shenzhen) Co., Ltd. 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?

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: under way, not looking for participants, as of the sponsor's last update on 23 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?

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?

Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery (time frame: Within 30 days after procedure). The study lists 3 primary outcomes in all. 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 NCT05126446, 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 23 Jul 2024.