Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study

Launched by LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. · Dec 5, 2022

Keywords

ClinConnect Summary

The Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study is researching a medical device called the Ankura Stent Graft, which is used to treat conditions like descending thoracic aortic aneurysms (DTA) and type B aortic dissections (TBAD). This trial aims to gather information about how safe and effective this device is for patients who need a specific type of repair called endovascular repair, which involves placing a stent through a blood vessel to fix the problem. The study is currently looking for participants aged 65 to 85 years who have been diagnosed with these conditions and have a life expectancy of more than a year.

If you or a loved one qualifies for this trial, you will need to agree to participate and complete a follow-up period of three years. Participants will be monitored closely to see how well the Ankura Stent Graft performs and to ensure their safety throughout the study. It’s important to note that certain health conditions may prevent someone from participating, such as severe infections, certain heart issues, or being pregnant. This study is designed to improve treatment options for patients with these serious aortic conditions, and your involvement could help advance medical knowledge and patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient has descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD), who needs endovascular repair (TEVAR).
• • Life expectancy \> 1 year.
• • Patient or legally authorized representative understands the nature of the clinical trial, agrees to its provisions, agrees to comply with the requirements of the study including a 3-year follow-up, and signed applicable Informed Consent Form.
• * Patient's characteristics consistent with Ankura™ Stent Graft System IFU and sizing guidelines, which indicate as following:
• 1. For descending thoracic aortic aneurysm (DTA) patient:
• • Adequate iliac/femoral access vessel that is compatible with the required delivery system.
• • Aortic inner diameter in the range of 18-42mm.
• • ≥15mm non-aneurysmal aorta proximal and distal to the lesion.
• • Morphology suitable for endovascular repair.
• 2. For type B aortic dissection (TBAD) patient:
• • Adequate iliac/femoral access vessel that is compatible with the required delivery system.
• • ≥15mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected. Diameter at proximal extent of proximal landing zone in the range of 16-44mm.
• • ≥15mm landing zone distal to the primary entry tear; distal extent of the landing zone must not be dissected. Diameter at distal extent of distal landing zone in the range of 16-44mm.
• • Morphology suitable for endovascular repair.
• Exclusion Criteria:
• * Patient with any contraindications mentioned in the Ankura™ Stent Graft System IFU:
• • Patients with acute systemic infection;
• • Patients who have had other devices implanted in the cardiovascular cavity, which will interfere with the placement of this device;
• • Patients with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
• • Patients who have allergic reaction to the device;
• • Patients who are not suitable for endovascular repair in vascular morphology;
• • Patients who cannot tolerate contrast agents due to severe renal insufficiency;
• • Patients who are allergic to contrast agents;
• • Aneurysms neck with thrombus;
• • Non-aneurysmal aortic proximal neck length \<1.5cm;
• • Non-aneurysmal aortic distal anchorage zone \<1.5cm;
• • For aneurysms, Non-aneurysmal aortic diameter \<18mm or \>42mm. For Type B dissections, Non-aneurysmal aortic diameter \<16mm or \>44mm.
• • Patient with traumatic aortic injury;
• • Patient with uncorrectable coagulopathy;
• • Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome;
• • Patient with morbid obesity, weight greater than 350 Pounds (150kg), or who cannot undergo accurate fluoroscopy examination due to obesity;
• • Age\<18 Years or Age\> 85 Years;
• • Pregnant or plan to be pregnant or breast feeding;
• • Myocardial infarction or stroke within 3 months prior to the procedure;
• • American Society of Anesthesiologists Physical Status Classification (ASA) classification 5 or higher;
• • Patient with an unstable angina pectoris or hearth insufficiency New York Heart Association Functional Classification (NYHA) 3 or 4
• • Participant in other drug or medical device clinical trials;
• • Patient with access vessel which are to tortuous, narrow or any kind of reasons that would lead to failure of introduction and advancing an introducer sheath;
• • Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.