Abdominal Aortic Aneurysms (AAA)NCT07754240
A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm
A study testing Ankura™ II Abdominal Aortic Stent Graft System in people with Abdominal Aortic Aneurysms (AAA), run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Bulgaria.
Trial summary
The objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal diameters of 24, 26, and 28 mm) for endovascular treatment of abdominal aortic aneurysm in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abdominal Aortic Aneurysms (AAA)
- What is being tested?
- Ankura™ II Abdominal Aortic Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBulgaria
- Study dates
- 30 Sep 2026to 30 Jun 2033
- 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
Who may be able to join
- 18 years ≤ age ≤80years, no gender limitation.
- Patients diagnosed with infrarenal abdominal aortic aneurysm and should meet at least one of the following conditions:
- The maximum diameter of abdominal aortic aneurysm is 55 mm or more in male patients or 50 mm or more in female patients;
- The maximum diameter of abdominal aortic aneurysm has increased by more than 5 mm in the last 6 months or 10 mm in the last 1 year;
- Abdominal aortic aneurysm oppresses important organs and viscera and causes symptoms (such as abdominal pain, lower back pain, etc.).
- Anatomical criteria:
Show all 13Show fewer
- Diameter of the proximal abdominal aortic aneurysm neck ranges from 17 mm to 33 mm;
- Length of the proximal abdominal aortic aneurysm neck ≥ 10 mm;
- Angle of the proximal abdominal aortic aneurysm neck ≤ 75 degrees;
- At least one side of the iliac artery anchorage zone has a diameter of 20 to 25 mm, while the other side of the iliac artery anchorage zone could be 7 to 25 mm；
- Length of the bilateral iliac artery anchorage zone ≥ 15mm;
- Adequate iliac or femoral vessel access
- Patients who are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent form, and are willing to complete the follow-up visits as per the protocol.
Who cannot join
- Patients with ruptured or leaking abdominal aortic aneurysm;
- Patients with infectious abdominal aortic aneurysm;
- Patients with abdominal aortic dissection;
- Patients with traumatic aortic disease;
- Patients with severe stenosis, calcification or mural thrombus in the stent anchoring zone likely to cause difficult covered stent apposition or the impact on stent patency;
- Patients with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
Show all 20Show fewer
- Patients with accessory renal artery original from abdominal artery;
- Patients who have undergone abdominal aortic surgery or endovascular intervention;
- Patients with stroke (Except for TIA), myocardial infarction or unstable angina within 3 months; The unstable angina is characterized by: progressively increased angina symptoms, new onset of angina while resting or during the night, or prolonged angina duration
- Patients with allergies to contrast agents, stent graft and delivery system materials (i.e., nitinol, polyester, PTFE, nylon polymer materials);
- Patients with allergies or contraindications to anticoagulant and antiplatelet drugs；
- Patients with abnormal hepatic and renal functions before operation (ALT or AST exceeding five times the upper limit of normal; STB exceeding two times the upper limit of normal; baseline serum creatinine exceeding 2.0 mg/dL (approximately 176.8 μmol/L));
- Patients who have undergone major surgery within 30 days prior to the procedure, or who are scheduled to undergo major surgery within 30 days following the procedure;
- Patients have morbid obesity (BMI of >40.0 kg/m2) or other clinical conditions that inhibit visualization of the aorta;
- Patients with systemic or localized infection likely to increase the risk of endovascular graft infection;
- Patients with connective tissue diseases related to the aorta, such as Marfan's syndrome;
- Patients with life expectancy of less than 1 year;
- Female patients who are in pregnancy or lactation, or plan to become pregnant;
- Patients who are not suitable for endovascular treatment according to the investigator's judgement;
- Patients who are participating in other device or drug clinical investigational studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria1 site, 1 recruiting
- Recruiting
MBAL Heart and Brain EAD
Pleven
Todor Samardjiev
About this study
The objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal diameters of 24, 26, and 28 mm) for endovascular treatment of abdominal aortic aneurysm in patients with infrarenal abdominal aortic aneurysm who are suitable for endovascular intervention.
The primary safety endpoint is the incidence of major adverse events within 30 days after the procedure. The primary efficacy endpoint is the 12-month treatment success rate.
Read the detailed description
The aorta is the largest artery in the human body, delivering oxygenated blood from the heart to the systemic circulation. An aortic aneurysm occurs when a weakened area of the aortic wall progressively dilates due to structural degeneration, resulting in an abnormal enlargement of the vessel. Abdominal aortic aneurysm (AAA) is characterized by localized dilatation of the abdominal aorta and represents one of the most common forms of aortic aneurysm.
An infrarenal abdominal aortic aneurysm (infrarenal AAA) is defined as an aneurysmal dilatation of the abdominal aorta located distal to the lowest renal artery and proximal to the aortic bifurcation. Infrarenal AAA is the most common anatomical subtype of AAA and represents the primary indication for endovascular aneurysm repair (EVAR) using standard infrarenal stent graft systems.
EVAR is a minimally invasive treatment approach that uses a covered stent graft to exclude the aneurysm sac from systemic blood flow, thereby reducing pressure on the aneurysm wall and minimizing the risk of aneurysm expansion and rupture. The procedure is typically performed through femoral arterial access. Under fluoroscopic guidance, the stent graft is delivered through the vascular system and deployed across the aneurysmal segment to establish a new blood flow channel while isolating the diseased aortic wall.
The Ankura™ II Abdominal Aortic Stent Graft System manufactured by Lifetech is the second generation of the Ankura™ stent graft system. This clinical investigation is conducted to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (IE stent grafts with distal diameters of 24, 26, and 28 mm) for the endovascular treatment of abdominal aortic aneurysms.
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Being tested
- Ankura™ II Abdominal Aortic Stent Graft System
- Keywords
- Abdominal Aortic Aneurysms (AAA), Lifetech Scientific, Ankura II Abdominal Aortic Stent Graft System
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankura™ II Abdominal Aortic Stent Graft SystemDevice
The Ankura™ II Abdominal Aortic Stent Graft System consists of preloaded stent grafts and dedicated delivery systems. The system includes abdominal aortic aneurysm (AAA) stent grafts, iliac artery extension (IE) stent grafts, and aortic extension (AE) stent grafts, each with its corresponding delivery system.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Participants will undergo endovascular aneurysm repair (EVAR) using the Ankura™ II Abdominal Aortic Stent Graft System manufactured by Lifetech Scientific. Receives: Device: Ankura™ II Abdominal Aortic Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Major adverse events (MAEs) within 30 days after operation.
MAEs are defined as a composite of all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
Measured: within 30-day post operation
12-month treatment success rate
The 12-month treatment success rate is a composite endpoint which should meet all of the following criteria:
- immediate technical success
- absence of aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm), aneurysm rupture, Type I / III endoleak and stent graft occlusion at 12-month post-operation
- no secondary intervention through 12-month post-operation.
Measured: intraoperative and 12-month post operation
Secondary outcomes (12)
Incidence of perioperative delivery-related complications
including intraoperative delivery system-related conversion to open surgery, haemorrhage, hematoma and pseudoaneurysm in the delivery approach
Measured: intraoperative, pre-discharge, and 30-day post operation
All-cause mortality
Measured: 6-month, 12-month, and 2- to 5-year post operation
AAA-related mortality
Measured: 6-month, 12-month, and 2- to 5-year post operation
Incidence of serious adverse events (SAEs)
Measured: 30-day, 6-month, 12-month, and 2- to 5-year post operation
Incidence of device-related adverse events (AEs)
Measured: 30-day, 6-month, 12-month, and 2- to 5-year post operation
Immediate technical success rate
Measured: intraoperative
Incidence of the AAA enlargement >5 mm
Measured: pre-discharge, 6-month, 12-month and 2-5 years post operation
Incidence of endoleak
Measured: intraoperative, pre-discharge, 6-month, 12-month and 2-5 years post operation
Incidence of stent graft migration > 10mm
Measured: 6-month, 12-month, 2-5 years post operation
Incidence of stent graft occlusion
Measured: intraoperative, pre-discharge,6-month, 12-month and 2-5 years post operation
Incidence of secondary intervention
Measured: pre-discharge, 30 days, 6-month, 12-month, and 2- to 5-year post operation
Incidence of AAA rupture
Measured: intraoperative, pre-discharge, 6-month, 12-month, and 2- to 5-year post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysms (AAA)Studies 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
- Model description
- Ankura II Abdominal Aortic Stent Graft System comprise preloaded stent grafts and delivery systems. The stent grafts include an Abdominal Aortic Aneurysm Stent Graft, an Iliac Artery Extension Stent Graft, and an Aortic Extension Stent Graft. Each stent has its dedicated delivery system.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
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
- NCT07754240
- Sponsor's protocol ID
- LT-TS-168I-2025-01
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT07754240
- Acronym / sponsor ID
- LT-TS-168I-2025-01
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Keywords
- Abdominal Aortic Aneurysms (AAA), Lifetech Scientific, Ankura II Abdominal Aortic Stent Graft System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 10 Aug 2026 (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 objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal diameters of 24, 26, and 28 mm) for endovascular treatment of abdominal aortic aneurysm in patients with infrarenal abdominal aortic aneurysm who are suitable for endovascular intervention.
The primary safety endpoint is the incidence of major adverse events within 30 days after the procedure. The primary efficacy endpoint is the 12-month treatment success rate.
Detailed description
The aorta is the largest artery in the human body, delivering oxygenated blood from the heart to the systemic circulation. An aortic aneurysm occurs when a weakened area of the aortic wall progressively dilates due to structural degeneration, resulting in an abnormal enlargement of the vessel. Abdominal aortic aneurysm (AAA) is characterized by localized dilatation of the abdominal aorta and represents one of the most common forms of aortic aneurysm.
An infrarenal abdominal aortic aneurysm (infrarenal AAA) is defined as an aneurysmal dilatation of the abdominal aorta located distal to the lowest renal artery and proximal to the aortic bifurcation. Infrarenal AAA is the most common anatomical subtype of AAA and represents the primary indication for endovascular aneurysm repair (EVAR) using standard infrarenal stent graft systems.
EVAR is a minimally invasive treatment approach that uses a covered stent graft to exclude the aneurysm sac from systemic blood flow, thereby reducing pressure on the aneurysm wall and minimizing the risk of aneurysm expansion and rupture. The procedure is typically performed through femoral arterial access. Under fluoroscopic guidance, the stent graft is delivered through the vascular system and deployed across the aneurysmal segment to establish a new blood flow channel while isolating the diseased aortic wall.
The Ankura™ II Abdominal Aortic Stent Graft System manufactured by Lifetech is the second generation of the Ankura™ stent graft system. This clinical investigation is conducted to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (IE stent grafts with distal diameters of 24, 26, and 28 mm) for the endovascular treatment of abdominal aortic aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ankura II Abdominal Aortic Stent Graft System comprise preloaded stent grafts and delivery systems. The stent grafts include an Abdominal Aortic Aneurysm Stent Graft, an Iliac Artery Extension Stent Graft, and an Aortic Extension Stent Graft. Each stent has its dedicated delivery system.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Ankura™ II Abdominal Aortic Stent Graft SystemParticipants will undergo endovascular aneurysm repair (EVAR) using the Ankura™ II Abdominal Aortic Stent Graft System manufactured by Lifetech Scientific. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years ≤ age ≤80years, no gender limitation.
- Patients diagnosed with infrarenal abdominal aortic aneurysm and should meet at least one of the following conditions:
- Anatomical criteria:
- Patients who are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent form, and are willing to complete the follow-up visits as per the protocol.
Key exclusion criteria (20 listed)
- Patients with ruptured or leaking abdominal aortic aneurysm;
- Patients with infectious abdominal aortic aneurysm;
- Patients with abdominal aortic dissection;
- Patients with traumatic aortic disease;
- Patients with severe stenosis, calcification or mural thrombus in the stent anchoring zone likely to cause difficult covered stent apposition or the impact on stent patency;
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™ II Abdominal Aortic Stent Graft SystemThe Ankura™ II Abdominal Aortic Stent Graft System consists of preloaded stent grafts and dedicated delivery systems. The system includes abdominal aortic aneurysm (AAA) stent grafts, iliac artery extension (IE) stent grafts, and aortic extension (AE) stent grafts, each with its corresponding delivery system. | Device | Single Arm |
Primary outcome
The incidence of Major adverse events (MAEs) within 30 days after operation.
Time frame: within 30-day post operation
MAEs are defined as a composite of all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
12-month treatment success rate
Time frame: intraoperative and 12-month post operation
The 12-month treatment success rate is a composite endpoint which should meet all of the following criteria: * immediate technical success * absence of aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm), aneurysm rupture, Type I / III endoleak and stent graft occlusion at 12-month post-operation * no secondary intervention through 12-month post-operation.
12 secondary outcomes
Incidence of perioperative delivery-related complications
Time frame: intraoperative, pre-discharge, and 30-day post operation
All-cause mortality
Time frame: 6-month, 12-month, and 2- to 5-year post operation
AAA-related mortality
Time frame: 6-month, 12-month, and 2- to 5-year post operation
Incidence of serious adverse events (SAEs)
Time frame: 30-day, 6-month, 12-month, and 2- to 5-year post operation
Incidence of device-related adverse events (AEs)
Time frame: 30-day, 6-month, 12-month, and 2- to 5-year post operation
Immediate technical success rate
Time frame: intraoperative
Incidence of the AAA enlargement >5 mm
Time frame: pre-discharge, 6-month, 12-month and 2-5 years post operation
Incidence of endoleak
Time frame: intraoperative, pre-discharge, 6-month, 12-month and 2-5 years post operation
Incidence of stent graft migration > 10mm
Time frame: 6-month, 12-month, 2-5 years post operation
Incidence of stent graft occlusion
Time frame: intraoperative, pre-discharge,6-month, 12-month and 2-5 years post operation
Incidence of secondary intervention
Time frame: pre-discharge, 30 days, 6-month, 12-month, and 2- to 5-year post operation
Incidence of AAA rupture
Time frame: intraoperative, pre-discharge, 6-month, 12-month, and 2- to 5-year post operation
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 18 Aug 2026.
Related trials for Abdominal Aortic Aneurysms (AAA)
Recruiting
Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)
AAA - Abdominal Aortic Aneurysm
Recruiting
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
AAA, AAA - Abdominal Aortic Aneurysm
RecruitingObservational study
Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
TAAA, AAA - Abdominal Aortic Aneurysm
Active, not recruitingObservational study
Endurant CHevAr New Indication Trial: ENCHANT
AAA - Abdominal Aortic Aneurysm
Recruiting
Nectero EAST System Retreatment Study
AAA - Abdominal Aortic Aneurysm, Aorta 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankura™ II Abdominal Aortic Stent Graft System in people with Abdominal Aortic Aneurysms (AAA), run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Bulgaria.
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 13 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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 Bulgaria. 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?
Contact Rae Gong ((86)-18820162460, gongrui@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Major adverse events (MAEs) within 30 days after operation. (time frame: within 30-day post operation). 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 18 Aug 2026.