Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AAA Subjects Patient diagnosed with Abdominal Aortic Aneurysm, who needs endovascular aortic repair. |
Device: Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System
Patients will be implanted with Ankura™ AAA, Cuff or AUI Stent Graft System in accordance with the Instructions for Use (IFU).
|
Outcome Measures
Primary Outcome Measures
- 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: Technical success, defined as delivery system delivered the stent graft at the desired position, stent graft deployed successfully. No aneurysm diameter dilation or aneurysm diameter dilation ≤ 5mm compared to baseline. No stent graft migration or stent graft migration ≤ 10mm. No re-intervention due to type I and III Endoleak. No aneurysm rupture. No conversion to Open Surgical Repair (OSR). No stent graft thrombosis.
Secondary Outcome Measures
- All-cause mortality [through 36 months post-procedure]
- Incidence of device-related or procedure-related SAE [through 36 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 stent migration (>10mm) [at 3-6 months, 12 months, and 24 months post-procedure]
- Incidence of stent fracture [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 stent embolization [through 36 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient diagnosed with Abdominal Aortic Aneurysm (AAA), who needs endovascular aortic repair;
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Patient's anatomy suits Ankura™ AAA and Cuff Stent Graft Systems, or AUI Stent Graft
IFU requirements, which indicated by the following:
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Adequate iliac/femoral access vessel that is compatible with the required delivery system.
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Non-aneurysmal proximal aortic neck length ≥15mm.
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Non-aneurysmal proximal aortic neck diameter of 18-32mm.
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Proximal aortic neck angulation ≤ 60°.
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Distal iliac artery anchorage zone ≥15mm.
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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).
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Morphology suitable for endovascular repair.
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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:
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Age<18 years or Age>85 years;
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Patients' life expectancy < 1 year;
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Pregnant or plan to be pregnant or breast feeding;
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Patient with any contraindications mentioned in the Ankura™ AAA and Cuff Stent Graft
Systems, or in Ankura™ AUI Stent Graft system IFU:
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Patient with acute systemic infection;
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Patient with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
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Patient with accessory renal artery original from abdominal artery;
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Patient who has allergic reaction to the device;
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Patient who is not suitable for endovascular repair in vascular morphology;
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Patient who cannot tolerate contrast agents due to renal insufficiency;
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Patient who is allergic to contrast agent;
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Patient's aneurysms neck has thrombus;
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Non-aneurysmal proximal aortic neck length <15mm;
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Non-aneurysmal proximal aortic neck diameter <18mm or >32mm;
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Proximal aortic neck angulation > 60°;
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Distal iliac artery anchorage zone <15mm;
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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.
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Patient with traumatic aortic injury;
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Patient with uncorrectable coagulopathy;
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Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome;
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Patient with concomitant thoracic aortic or thoraco-abdominal aneurysms；
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Patient who weighs greater than 350 pounds (150kg) or cannot undergo accurate fluoroscopy examination due to obesity.
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Acute myocardial infarction or heart failure (NYHA class III and IV), respiratory failure, malignant tumor and other serious systemic diseases.
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Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints.
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Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MBAL Heart and Brain EAD | Pleven | Bulgaria | 5804 | |
| 2 | National Hospital of Cardiology | Sofia | Bulgaria | 1309 | |
| 3 | Military Medical Academy | Sofia | Bulgaria | 1606 | |
| 4 | University Hospital for Active Treatment "Sofiamed" | Sofia | Bulgaria | 1797 | |
| 5 | Ankara University Heart Center | Ankara | Turkey | 06340 | |
| 6 | Ankara City Hospital | Ankara | Turkey | 06800 |
Sponsors and Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LT/TS/12C-2021-02