Clinical trial NCT05864560: Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Official title: Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Single-arm, Open-label, Post-market Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Abdominal Aortic Aneurysm
Keywords: Lifetech
Ankura
Endovascular Aneurysm Repair
Abdominal Aortic Aneurysm
Stent Graft System
EVAR
AAA
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient diagnosed with Abdominal Aortic Aneurysm, who needs endovascular aortic repair.

Brief summary: The objective of the study is to collect real-world data on patient outcomes and evaluate the safety and performance of the Lifetech Ankura™ AAA Stent Graft System, Ankura™ Cuff Stent Graft System, Ankura™ AUI Stent Graft System and ZoeTrack™ Super Stiff Guidewire.

Detailed description: Abdominal aortic aneurysm (AAA) is the most common true arterial aneurysm. Surgical management options for AAA include traditional Open Surgical Repair (OSR) and minimally invasive Endovascular Aneurysm Repair (EVAR). Multiple endovascular devices are commercially available for repair of AAA. Currently available endovascular grafts for infrarenal aortic repair share a bifurcated, modular design. Ankura™ Stent Graft Systems are minimally invasive endovascular devices that offer an alternative treatment for patients with AAA, which have been marketed worldwide for many years. In order to evaluate the long-term safety and performance of the investigational device from real world, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 162 subjects. The anticipated enrollment period is approximately 1.5 years and subjects will be followed for 3 years (36 months) post-implantation.

Eligibility criteria: Inclusion Criteria:

1. Patient diagnosed with Abdominal Aortic Aneurysm (AAA), who needs endovascular aortic repair;
2. Patient's anatomy suits Ankura™ AAA and Cuff Stent Graft Systems, or AUI Stent Graft IFU requirements, which indicated by the following:

   1. Adequate iliac/femoral access vessel that is compatible with the required delivery system.
   2. Non-aneurysmal proximal aortic neck length ≥15mm.
   3. Non-aneurysmal proximal aortic neck diameter of 18-32mm.
   4. Proximal aortic neck angulation ≤ 60°.
   5. Distal iliac artery anchorage zone ≥15mm.
   6. Distal iliac artery diameter of i. 8-22 mm (for Ankura™ AAA and Cuff Stent Graft Systems), OR ii. 10-16 mm (for Ankura™ AUI Stent Graft System).
   7. Morphology suitable for endovascular repair.
3. Patient could understand the purpose of the clinical trial, agrees to comply with the requirements of the study including the 3-year follow-up, and signed the patient informed consent, will participate in the study.

Exclusion Criteria:

1. Age\<18 years or Age\>85 years;
2. Patients' life expectancy \< 1 year;
3. Pregnant or plan to be pregnant or breast feeding;
4. Patient with any contraindications mentioned in the Ankura™ AAA and Cuff Stent Graft Systems, or in Ankura™ AUI Stent Graft system IFU:

   1. Patient with acute systemic infection;
   2. Patient with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
   3. Patient with accessory renal artery original from abdominal artery;
   4. Patient who has allergic reaction to the device;
   5. Patient who is not suitable for endovascular repair in vascular morphology;
   6. Patient who cannot tolerate contrast agents due to renal insufficiency;
   7. Patient who is allergic to contrast agent;
   8. Patient's aneurysms neck has thrombus;
   9. Non-aneurysmal proximal aortic neck length \<15mm;
   10. Non-aneurysmal proximal aortic neck diameter \<18mm or \>32mm;
   11. Proximal aortic neck angulation \> 60°;
   12. Distal iliac artery anchorage zone \<15mm;
   13. Distal iliac artery diameter: i. For Ankura™ AAA and Cuff Stent Graft Systems: \<8mm or \>22mm, OR ii. For Ankura™ AUI Stent Graft system: \<10mm or \>16mm.
5. Patient with traumatic aortic injury;
6. Patient with uncorrectable coagulopathy;
7. Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome;
8. Patient with concomitant thoracic aortic or thoraco-abdominal aneurysms；
9. Patient who weighs greater than 350 pounds (150kg) or cannot undergo accurate fluoroscopy examination due to obesity.
10. Acute myocardial infarction or heart failure (NYHA class III and IV), respiratory failure, malignant tumor and other serious systemic diseases.
11. Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints.
12. Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.

Primary outcomes:
measure: Incidence of Major Adverse Events (MAE)
timeFrame: within 30 days post-procedure
measure: 12-month Treatment Success Rate
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: All-cause mortality
timeFrame: through 36 months post-procedure
measure: Incidence of device-related or procedure-related SAE
timeFrame: through 36 months post-procedure
measure: Incidence of abdominal aneurysm-related or stent graft-related secondary intervention, including Endovascular Aortic Repair (EVAR) and open surgery
timeFrame: through 36 months post-procedure
measure: Incidence of stent migration (>10mm)
timeFrame: at 3-6 months, 12 months, and 24 months post-procedure
measure: Incidence of stent fracture
timeFrame: at 3-6 months, 12 months, and 24 months post-procedure
measure: Incidence of stent thrombosis
timeFrame: at 3-6 months, 12 months, and 24 months post-procedure
measure: Incidence of stent embolization
timeFrame: through 36 months post-procedure
measure: Immediate procedure success rate
timeFrame: immediately after the procedure
measure: Incidence of Type I, III, IV Endoleak
timeFrame: at 3-6 months, 12 months, and 24 months post-procedure
measure: Incidence of aneurysm enlargement (>5mm, compared to baseline)
timeFrame: at 3-6 months, 12 months and 24 months post-procedure
measure: Incidence of aneurysm/vessel rupture
timeFrame: through 36 months post-procedure
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: MBAL Heart and Brain EAD
city: Sofia
country: Bulgaria
facility: University Hospital for Active Treatment "Sofiamed"
city: Athens
country: Greece
facility: Laiko - University Hospital of Athens
city: Patras
country: Greece
facility: General University Hospital of Patras
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
city: Ankara
country: Turkey
facility: Ankara University Heart Center
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References: