Aneurysm ThoracicNCT05639569
Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study
An observational study of Aneurysm Thoracic and Dissection of Thoracic Aorta, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 15 sites in 5 countries.
Trial summary
The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aneurysm Thoracic, Dissection of Thoracic Aorta
- What is being tested?
- Ankura™ TAA Stent Graft System
- Type of treatment
- Medical device
- How many people
- 147 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 3 May 2023to 30 Dec 2030
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) and indicate for endovascular repair (TEVAR).
Who may be able to join
- Patient has descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD), who needs endovascular repair (TEVAR).
- Life expectancy > 1 year.
- Patient or legally authorized representative understands the nature of the clinical trial, agrees to its provisions, agrees to comply with the requirements of the study including a 3-year follow-up, and signed applicable Informed Consent Form.
- Patient's characteristics consistent with Ankura™ Stent Graft System IFU and sizing guidelines, which indicate as following:
- For descending thoracic aortic aneurysm (DTA) patient:
- Adequate iliac/femoral access vessel that is compatible with the required delivery system.
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- Aortic inner diameter in the range of 18-42mm.
- ≥15mm non-aneurysmal aorta proximal and distal to the lesion.
- Morphology suitable for endovascular repair.
- For type B aortic dissection (TBAD) patient:
- Adequate iliac/femoral access vessel that is compatible with the required delivery system.
- ≥15mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected. Diameter at proximal extent of proximal landing zone in the range of 16-44mm.
- ≥15mm landing zone distal to the primary entry tear; distal extent of the landing zone must not be dissected. Diameter at distal extent of distal landing zone in the range of 16-44mm.
- Morphology suitable for endovascular repair.
Who cannot join
- Patient with any contraindications mentioned in the Ankura™ Stent Graft System IFU:
- Patients with acute systemic infection;
- Patients who have had other devices implanted in the cardiovascular cavity, which will interfere with the placement of this device;
- Patients with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
- Patients who have allergic reaction to the device;
- Patients who are not suitable for endovascular repair in vascular morphology;
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- Patients who cannot tolerate contrast agents due to severe renal insufficiency;
- Patients who are allergic to contrast agents;
- Aneurysms neck with thrombus;
- Non-aneurysmal aortic proximal neck length <1.5cm;
- Non-aneurysmal aortic distal anchorage zone <1.5cm;
- For aneurysms, Non-aneurysmal aortic diameter <18mm or >42mm. For Type B dissections, Non-aneurysmal aortic diameter <16mm or >44mm.
- Patient with traumatic aortic injury;
- Patient with uncorrectable coagulopathy;
- Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome;
- Patient with morbid obesity, weight greater than 350 Pounds (150kg), or who cannot undergo accurate fluoroscopy examination due to obesity;
- Age<18 Years or Age> 85 Years;
- Pregnant or plan to be pregnant or breast feeding;
- Myocardial infarction or stroke within 3 months prior to the procedure;
- American Society of Anesthesiologists Physical Status Classification (ASA) classification 5 or higher;
- Patient with an unstable angina pectoris or hearth insufficiency New York Heart Association Functional Classification (NYHA) 3 or 4
- Participant in other drug or medical device clinical trials;
- Patient with access vessel which are to tortuous, narrow or any kind of reasons that would lead to failure of introduction and advancing an introducer sheath;
- Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Turkey (Türkiye)7 sites
Ankara Bilkent City Hospital
Ankara
Ankara Etlik City Hospital
Ankara
Ankara University Hospital Heart Center
Ankara
Erzurum University Hospital
Erzurum
Eskişehir City Hospital
Eskişehir
Gaziantep City Hospital
Gaziantep
Izmir City Hospital
Izmir
Greece3 sites
Evaggelismos General Hospital
Athens
General Hospital of Athens - Georgios Gennimatas
Athens
University General Hospital - Attikon
Attiki
Germany2 sites
Asklepios Klinik Nord Heidberg
Hamburg
St. Franziskus Hospital Münster
Münster
Russia2 sites
Petrovsky National Research Centre of Surgery
Moscow
Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre
Saint Petersburg
About this study
Official title: Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study: Multi-center, Prospective, Observational, Post-Market Follow-up Study
The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD).
Read the detailed description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
- Conditions
- Aneurysm Thoracic, Dissection of Thoracic Aorta
- Being tested
- Ankura™ TAA Stent Graft System
- Medical subject headings
- Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankura™ TAA Stent Graft SystemDevice
All patients will be implanted with Ankura™ TAA Stent Graft System in accordance with the instructions for use (IFU).
| Study group | Role | What they receive |
|---|---|---|
| Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) | All patients who signed informed consent and are used with Ankura™ TAA Stent Graft Systems will undergo follow-up (FU) evaluations as per local hospital standards and corresponding IFU which is expected to be at the following time points post-implant:
Before discharge, 30days after the procudure, 3-6 months after the Procedure, 12 months after the procedure, 24 months after the procedure, 36 months after the procedure Receives: Device: Ankura™ TAA Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse events
Incidence of major adverse events.
Measured: Timeframe: within 30-day post-implantation
Freedom from stent graft-related events
Freedom from stent graft-related events (12 months)
Measured: Timeframe: within 12-month post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start3 May 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm ThoracicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639569
- Sponsor's protocol ID
- LT/TS/12C-2021-01
- Status last verified
- May 2026
- First submitted
- 26 Nov 2022
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study: Multi-center, Prospective, Observational, Post-Market Follow-up Study
- ClinicalTrials.gov ID
- NCT05639569
- Acronym / sponsor ID
- LT/TS/12C-2021-01
- Conditions
- Aneurysm Thoracic, Dissection of Thoracic Aorta
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 May 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 6 Dec 2022 (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.
The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD).
Detailed description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) | – | Device: Ankura™ TAA Stent Graft SystemAll patients who signed informed consent and are used with Ankura™ TAA Stent Graft Systems will undergo follow-up (FU) evaluations as per local hospital standards and corresponding IFU which is expected to be at the following time points post-implant: Before discharge, 30days after the procudure, 3-6 months after the Procedure, 12 months after the procedure, 24 months after the procedure, 36 months after the procedure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) and indicate for endovascular repair (TEVAR).
Key inclusion criteria (14 listed)
- Patient has descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD), who needs endovascular repair (TEVAR).
- Life expectancy > 1 year.
- Patient or legally authorized representative understands the nature of the clinical trial, agrees to its provisions, agrees to comply with the requirements of the study including a 3-year follow-up, and signed applicable Informed Consent Form.
- Patient's characteristics consistent with Ankura™ Stent Graft System IFU and sizing guidelines, which indicate as following:
Key exclusion criteria (24 listed)
- Patient with any contraindications mentioned in the Ankura™ Stent Graft System IFU:
- Patient with traumatic aortic injury;
- Patient with uncorrectable coagulopathy;
- Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome;
- Patient with morbid obesity, weight greater than 350 Pounds (150kg), or who cannot undergo accurate fluoroscopy examination due to obesity;
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 |
|---|---|---|
| Ankura™ TAA Stent Graft SystemAll patients will be implanted with Ankura™ TAA Stent Graft System in accordance with the instructions for use (IFU). | Device | Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) |
Primary outcome
Incidence of major adverse events
Time frame: Timeframe: within 30-day post-implantation
Incidence of major adverse events.
Freedom from stent graft-related events
Time frame: Timeframe: within 12-month post-implantation
Freedom from stent graft-related events (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 26 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Thoracic and Dissection of Thoracic Aorta, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 15 sites in 5 countries.
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 14 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Turkey (Türkiye), Greece, Germany, Russia, Italy. 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?
Incidence of major adverse events (time frame: Timeframe: within 30-day post-implantation). 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?
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 26 May 2026.