Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up

Recruiting

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System

• Registration Number: NCT05864560
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Study Start: 2023-09-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15
• Primary Completion: 2026-03
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AAA Subjects	Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System	Patient diagnosed with Abdominal Aortic Aneurysm, who needs endovascular aortic repair.

Primary Outcome Measures

Name	Time	Method
Incidence of Major Adverse Events (MAE)	within 30 days post-procedure	MAEs are defined as all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
12-month Treatment Success Rate	12 months post-procedure	Rate of successful endovascular aneurysm repair with Ankura™ AAA and Cuff Stent Graft Systems or Ankura™ AUI Stent Graft system in 12 months. A successful repair should meet ALL the following requirements: 1. Technical success, defined as delivery system delivered the stent graft at the desired position, stent graft deployed successfully.; 2. No aneurysm diameter dilation or aneurysm diameter dilation ≤ 5mm compared to baseline.; 3. No stent graft migration or stent graft migration ≤ 10mm.; 4. No re-intervention due to type I and III Endoleak.; 5. No aneurysm rupture.; 6. No conversion to Open Surgical Repair (OSR).; 7. No stent graft thrombosis.

Secondary Outcome Measures

Name	Time	Method
Incidence of device-related or procedure-related SAE	through 36 months post-procedure
Incidence of stent fracture	at 3-6 months, 12 months, and 24 months post-procedure
Immediate procedure success rate	immediately after the procedure	Defined as Ankura™ stent graft is successfully implanted at the desirable place guided by Lifetech ZoeTrack™ Super Stiff Guidewire.
Incidence of Type I, III, IV Endoleak	at 3-6 months, 12 months, and 24 months post-procedure
All-cause mortality	through 36 months post-procedure
Incidence of stent embolization	through 36 months post-procedure
Incidence of stent migration (>10mm)	at 3-6 months, 12 months, and 24 months post-procedure
Incidence of stent thrombosis	at 3-6 months, 12 months, and 24 months post-procedure
Incidence of abdominal aneurysm-related or stent graft-related secondary intervention, including Endovascular Aortic Repair (EVAR) and open surgery	through 36 months post-procedure
Incidence of aneurysm enlargement (>5mm, compared to baseline)	at 3-6 months, 12 months and 24 months post-procedure
Incidence of aneurysm/vessel rupture	through 36 months post-procedure

Trial Locations

Locations (9)

University Hospital for Active Treatment "Sofiamed"; 🇧🇬 Sofia, Bulgaria

MBAL Heart and Brain EAD; 🇧🇬 Pleven, Bulgaria

National Hospital of Cardiology; 🇧🇬 Sofia, Bulgaria

Military Medical Academy; 🇧🇬 Sofia, Bulgaria

General University Hospital of Patras; 🇬🇷 Patras, Greece

Ankara University Heart Center; 🇹🇷 Ankara, Turkey

Laiko - University Hospital of Athens; 🇬🇷 Athens, Greece

Papageorgiou General Hospital; 🇬🇷 Thessaloniki, Greece

Ankara City Hospital; 🇹🇷 Ankara, Turkey