A Clinical Investigational Study of AnkuraTM II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm

NCT07754240 | Not Yet Recruiting

• 1 other identifier: LT-TS-168I-2025-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Abdominal Aortic Aneurysms (AAA)

Keywords

Abdominal Aortic Aneurysms (AAA); Lifetech Scientific; Ankura II Abdominal Aortic Stent Graft System

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  intraoperative and 12-month post operation

Secondary Outcomes (11)

• Incidence of perioperative delivery-related complications

  intraoperative, pre-discharge, and 30-day post operation

• All-cause mortality

  6-month, 12-month, and 2- to 5-year post operation

• AAA-related mortality

  6-month, 12-month, and 2- to 5-year post operation

• Incidence of serious adverse events (SAEs)

  30-day, 6-month, 12-month, and 2- to 5-year post operation

• Incidence of device-related adverse events (AEs)

  30-day, 6-month, 12-month, and 2- to 5-year post operation

Study Arms (1)

Single Arm

EXPERIMENTAL

Participants will undergo endovascular aneurysm repair (EVAR) using the Ankura™ II Abdominal Aortic Stent Graft System manufactured by Lifetech Scientific.

Device: AnkuraTM II Abdominal Aortic Stent Graft System; Device: Ankura™ II Abdominal Aortic Stent Graft System

Interventions

AnkuraTM II Abdominal Aortic Stent Graft System DEVICE

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.

Single Arm

Ankura™ II Abdominal Aortic Stent Graft System DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (2)

MBAL Heart and Brain EAD

Pleven, Bulgaria

Location

Military Medical Academy

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Rae Gong

CONTACT

(86)-18820162460; gongrui@lifetechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 30, 2032
• Study Completion (Estimated): May 30, 2033
• Last Updated: August 10, 2026

Record last verified: 2026-07

Locations

BU (2)