Thoracic Aortic DissectionNCT03767777
Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY（PATENCY）
A study testing Artery Stent Graft System in people with Thoracic Aortic Dissection, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 21 sites in China.
Trial summary
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the thoracic aortic dissection involving the aortic arch. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thoracic Aortic Dissection
- What is being tested?
- Artery Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 21 sitesChina
- Study dates
- 1 Feb 2019to 1 Jun 2025
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are 18 years and older, but less than 85 years old and not pregnant or lactating;
- Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;
- Patients diagnosed as thoracic aortic dissection involving the arch, and the left subclavian artery branching vessel needs to be revascularized;
- Aortic proximal landing zone ≥15mm；
- Aortic proximal diameter in the range of 25-44mm;
- The left subclavian artery distal landing zone≥15mm;
- The left subclavian artery diameter in the range of 5-18mm；
- Patients who have eligible imported arterial vessels.
Who cannot join
- Patients with severe stenosis, calcification in the landing area of the stent and easily lead to incomplete stent apposition;
- Patients need intervention for other vascular diseases (such as coronary artery /renal artery) in the same surgery, or patients with heart disease and medicine treatment will be affected by the intervention；
- Patients with a history of myocardial infraction or acute coronary syndromes in 3 months；
- Patients with a history of cerebrovascular events or gastrointestinal bleeding in 3 months, antiplatelet agent and anticoagulant contraindication, or tendency of hemorrhage；
- Patients have received any major surgical or interventional therapy within 30 days (Operation Classification reaches III or above) or have received interventional therapy;
- Patients will receive any major selective operation or interventional therapy in 30days (Operation Classification reaches III or above) or will received interventional therapy;
Show all 19Show fewer
- Patients already treated with an thoracic aortic stent graft and the stent graft can affect operation or intersection part existing between the graft covering area；
- Patients with genetic connective tissue disease (e.g., Marfans syndrome) or aorta hereditary disease；
- Patients with infectious aortic dissection;
- Patients with acute systemic infection;
- Patients with major organ failure or other serious diseases;
- Patients with a history of active bleeding, clotting disorder, or rejection of blood transfusions;
- Patients with liver dysfunction: preoperative creatinine was 2.5 times higher than the normal upper limit; Alanine transaminase (ALT) or Aspartate transaminase (AST) were 5 times higher than the normal upper limit; serum total bilirubin (STB) was 2 times higher than the normal upper limit;
- Pregnant or lactating women or women who plan to get pregnant;
- Patients who can not tolerate to Anaesthetic；
- Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials);
- Patients with a life expectancy less than 12 months（such as terminal malignant tumor）；
- Patients who were not suitable for endovascular treatment, judged by the investigator;
- Patients who participated in clinical trials of other drugs or medical devices at the same time.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Fuwai hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Chinese PLA General Hospita
Beijing, Beijing Municipality
The First Hospital of Jilin University
Changchun, Jilin
The Second Xiangya Hospital of Central South University
Changsha, Hunan
West China hospital of sichuan university
Chengdu, Sichuan
The second affiliated hospital of Harbin medical university
Harbin, Heilongjiang
Shandong Provincial Hospital
Jinan, Shandong
The first people's hospital of yunnan province
Kunming, Yunnan
The Frist Hospital of Lanzhou University
Lanzhou, Gansu
LIU ZHOU WORKER'S HOSPITAL,Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
The first affiliated hospital of soochow university
Suzhou, Jiangsu
Tianjin Chest Hospital
Tianjin, Tianjin Municipality
Tianjing Medical University General Hospital
Tianjin, Tianjin Municipality
The Central Hospital of Wuhan
Wuhan, Hubei
Tongji Hospital,Tongji Medical College of Huazhong University of Science&Technology
Wuhan, Hubei
Xijing Hospital, The Fourth Military Medical University
Xi’an, Shanxi
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
Official title: Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY：A Prospective, Multi-center, Objective Performance Criteria Clinical Trial
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the thoracic aortic dissection involving the aortic arch.
Read the detailed description
This clinical trial was conducted in a qualified clinical trial institution. Investigators will use Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. to treat patients with thoracic aortic dissection involving the aortic arch. This is a Prospective, Multi-center, Objective Performance Criteria Clinical Trial. It is expected to submit to the ethics committee of the lead unit for review in Sep 2018, and complete the implantation of 150 patients in 18 centres nationwide within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.
This trial will evaluate whether the device reached the primary safety endpoint and primary efficacy endpoint through two primary endpoint indicators: the incidence of major adverse events (MAE) within 30 days and the success rate of aortic dissection treatment 12 months after surgery.
This trail will evaluate whether the device reached the secondary safety endpoint and efficacy endpoint through several secondary endpoint indicators:
- the incidence of all-cause death at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of thoracic aortic dissection-related death at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of severe adverse events (SAE) at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of the device-related adverse events (AE) at 30 days, 6 months, 12 months and 2-5 years after surgery
- the Incidence of left upper limb ischemia at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of type I or type III leakage at 30 days, 6 months, 12 months after surgery
- the incidence of graft migration at 30 days, 6 months, 12 months after surgery
- the branching vascular patency rate at 30 days, 6 months, 12 months after surgery
- the Incidence of Thoracic aortic dissection -related surgical conversion or re-intervention at 30 days, 6 months, 12 months and 2-5 years after surgery According to the guidelines for clinical trials of aortic stent system, the sponsor will apply for NMPA listing registration after completing a 12-month primary endpoint assessment, and annually follow-up will be conducted until the fifth year for the long-term efficacy observation.
- Conditions
- Thoracic Aortic Dissection
- Being tested
- Artery Stent Graft System
- Keywords
- Aortic arch, Aortic disease, Aortic Dissection, Stent Graft
- Medical subject headings
- Dissection, Thoracic Aorta, Aortic Diseases, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artery Stent Graft SystemDevice
The Artery Stent Graft System consists of Ankura pro Aorta Stent Graft System along with Longuette Aortic Branch Stent Graft System for chimney technique in the aim of revascularization of aorta branches.The Ankura pro aorta stent graft and Longuette Aortic Branch Stent Graft System are pre-assembled within delivery system. During the operation, the stent graft was delivered to the target lesion location of the vascular real cavity through a delivery system, which was accurately positioned and released to isolate the ruptured opening of aortic dissection, block the continuous flow of blood into the false cavity of the dissection, and avoid further tearing or even rupture of the dissection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants will be treated with Artery Stent Graft System Intervention: Device: Artery Stent Graft System Receives: Device: Artery Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The treatment success rate of aortic dissection at 12 months post-implant
Assessment of the rate of successful disease treatment defined as immediate technical success and freedom from secondary intervention at 12 months of follow-up.
Technique success means delivery system is successfully transported to the predetermined position, both of aorta stent graft and aortic branch stent graft successfully expanded and delivery system withdraw successfully.No type I/III endoleak at the end of operation, no conversion to open surgery. (Adjuvant Interventions during operation do not defined as technical failure.)
Measured: 12 months after surgery
Incidence of no major adverse events (MAE) occurred at 30 days post-implant
Major Adverse events (MAE) are defined as aortic dissection related mortality, ischemic stroke, and paraplegia.
Measured: 30 days after surgery
Secondary outcomes (9)
Incidence of all-cause death
Measured: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of Aortic dissection dissection-related death
Measured: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of Serious Major Adverse Event（SAE）
Measured: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of device related adverse events（AE）
Measured: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of left upper limb ischemia
Measured: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of I/III type endoleaks
Measured: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of graft migration
Measured: 30 days，6 months, 12 months and 2-5 years after surgery
Branching vascular patency rate
Measured: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of Thoracic aortic dissection -related surgical conversion or re-intervention
Measured: 30 days，6 months, 12 months and 2-5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Feb 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thoracic 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang Shu, professor, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767777
- Sponsor's protocol ID
- LTP84-01
- Status last verified
- Jun 2025
- First submitted
- 5 Dec 2018
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shu C, Wan Z, Luo M, Fang K, Hu J, Zuo J, Li X, Li Q, He H, Li X. Mid-term results of a prospective study for aortic dissection with a gutter-plugging chimney stent graft. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae135. doi: 10.1093/ejcts/ezae135.
PubMed 38569918Liu Y, Fang K, Luo MY, Xiao ZH, Yang P, Lu C, Zhang Y, Wang HY, Xie Y, Xu ZY, Zhang HW, Shu C, Hu J. Single-Center Preliminary Experience with Gutter-Plugging Chimney Stent-Graft for Aortic Dissection. Cardiovasc Intervent Radiol. 2023 Jun;46(6):703-712. doi: 10.1007/s00270-023-03444-8. Epub 2023 May 17.
PubMed 37198293
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY：A Prospective, Multi-center, Objective Performance Criteria Clinical Trial
- ClinicalTrials.gov ID
- NCT03767777
- Acronym / sponsor ID
- LTP84-01
- Conditions
- Thoracic Aortic Dissection
- Keywords
- Aortic arch, Aortic disease, Aortic Dissection, Stent Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 7 Dec 2018 (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.
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the thoracic aortic dissection involving the aortic arch.
Detailed description
This clinical trial was conducted in a qualified clinical trial institution. Investigators will use Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. to treat patients with thoracic aortic dissection involving the aortic arch. This is a Prospective, Multi-center, Objective Performance Criteria Clinical Trial. It is expected to submit to the ethics committee of the lead unit for review in Sep 2018, and complete the implantation of 150 patients in 18 centres nationwide within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.
This trial will evaluate whether the device reached the primary safety endpoint and primary efficacy endpoint through two primary endpoint indicators: the incidence of major adverse events (MAE) within 30 days and the success rate of aortic dissection treatment 12 months after surgery.
This trail will evaluate whether the device reached the secondary safety endpoint and efficacy endpoint through several secondary endpoint indicators:
- the incidence of all-cause death at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of thoracic aortic dissection-related death at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of severe adverse events (SAE) at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of the device-related adverse events (AE) at 30 days, 6 months, 12 months and 2-5 years after surgery
- the Incidence of left upper limb ischemia at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of type I or type III leakage at 30 days, 6 months, 12 months after surgery
- the incidence of graft migration at 30 days, 6 months, 12 months after surgery
- the branching vascular patency rate at 30 days, 6 months, 12 months after surgery
- the Incidence of Thoracic aortic dissection -related surgical conversion or re-intervention at 30 days, 6 months, 12 months and 2-5 years after surgery According to the guidelines for clinical trials of aortic stent system, the sponsor will apply for NMPA listing registration after completing a 12-month primary endpoint assessment, and annually follow-up will be conducted until the fifth year for the long-term efficacy observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Artery Stent Graft SystemParticipants will be treated with Artery Stent Graft System Intervention: Device: Artery Stent Graft System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients are 18 years and older, but less than 85 years old and not pregnant or lactating;
- Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;
- Patients diagnosed as thoracic aortic dissection involving the arch, and the left subclavian artery branching vessel needs to be revascularized;
- Aortic proximal landing zone ≥15mm；
- Aortic proximal diameter in the range of 25-44mm;
Key exclusion criteria (19 listed)
- Patients with severe stenosis, calcification in the landing area of the stent and easily lead to incomplete stent apposition;
- Patients need intervention for other vascular diseases (such as coronary artery /renal artery) in the same surgery, or patients with heart disease and medicine treatment will be affected by the intervention；
- Patients with a history of myocardial infraction or acute coronary syndromes in 3 months；
- Patients with a history of cerebrovascular events or gastrointestinal bleeding in 3 months, antiplatelet agent and anticoagulant contraindication, or tendency of hemorrhage；
- Patients have received any major surgical or interventional therapy within 30 days (Operation Classification reaches III or above) or have received interventional therapy;
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 |
|---|---|---|
| Artery Stent Graft SystemThe Artery Stent Graft System consists of Ankura pro Aorta Stent Graft System along with Longuette Aortic Branch Stent Graft System for chimney technique in the aim of revascularization of aorta branches.The Ankura pro aorta stent graft and Longuette Aortic Branch Stent Graft System are pre-assembled within delivery system. During the operation, the stent graft was delivered to the target lesion location of the vascular real cavity through a delivery system, which was accurately positioned and released to isolate the ruptured opening of aortic dissection, block the continuous flow of blood into the false cavity of the dissection, and avoid further tearing or even rupture of the dissection. | Device | Intervention arm |
Primary outcome
The treatment success rate of aortic dissection at 12 months post-implant
Time frame: 12 months after surgery
Assessment of the rate of successful disease treatment defined as immediate technical success and freedom from secondary intervention at 12 months of follow-up. Technique success means delivery system is successfully transported to the predetermined position, both of aorta stent graft and aortic branch stent graft successfully expanded and delivery system withdraw successfully.No type I/III endoleak at the end of operation, no conversion to open surgery. (Adjuvant Interventions during operation do not defined as technical failure.)
Incidence of no major adverse events (MAE) occurred at 30 days post-implant
Time frame: 30 days after surgery
Major Adverse events (MAE) are defined as aortic dissection related mortality, ischemic stroke, and paraplegia.
9 secondary outcomes
Incidence of all-cause death
Time frame: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of Aortic dissection dissection-related death
Time frame: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of Serious Major Adverse Event（SAE）
Time frame: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of device related adverse events（AE）
Time frame: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of left upper limb ischemia
Time frame: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of I/III type endoleaks
Time frame: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of graft migration
Time frame: 30 days，6 months, 12 months and 2-5 years after surgery
Branching vascular patency rate
Time frame: 30 days，6 months, 12 months and 2-5 years after surgery
Incidence of Thoracic aortic dissection -related surgical conversion or re-intervention
Time frame: 30 days，6 months, 12 months and 2-5 years after surgery
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 18 Jun 2025.
- Derived from this study: PubMed 38569918Shu C, Wan Z, Luo M, Fang K, Hu J, Zuo J, Li X, Li Q, He H, Li X. Mid-term results of a prospective study for aortic dissection with a gutter-plugging chimney stent graft. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae135. doi: 10.1093/ejcts/ezae135.
- Derived from this study: PubMed 37198293Liu Y, Fang K, Luo MY, Xiao ZH, Yang P, Lu C, Zhang Y, Wang HY, Xie Y, Xu ZY, Zhang HW, Shu C, Hu J. Single-Center Preliminary Experience with Gutter-Plugging Chimney Stent-Graft for Aortic Dissection. Cardiovasc Intervent Radiol. 2023 Jun;46(6):703-712. doi: 10.1007/s00270-023-03444-8. Epub 2023 May 17.
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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.
Chang Shu, professor principal investigator
Central South University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artery Stent Graft System in people with Thoracic Aortic Dissection, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 21 sites 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 8 inclusion and 19 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 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
The treatment success rate of aortic dissection at 12 months post-implant (time frame: 12 months after surgery). The study lists 2 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 NCT03767777, which also lists 2 linked publications.
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 18 Jun 2025; AzTrials last refreshed its copy on 1 Nov 2026.