Follow-up on Ankura TAA Stent Graft System for aortic conditions

Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study: Multi-center, Prospective, Observational, Post-Market Follow-up Study

This study is testing how well the Ankura TAA Stent Graft System works and is safe for people with certain aortic conditions who need a specific type of repair.

Quick facts

• Study type: Observational
• Enrollment: 145 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (Industry-sponsored)
• Locations: 8 sites (Bad Neustadt an der Saale and 7 other locations)
• Trial ID: NCT05639569 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect clinical data on patient outcomes and evaluate the safety and performance of the Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire in patients with descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD). It focuses on individuals who require endovascular repair and will involve a follow-up period of three years to gather comprehensive evidence on the device's effectiveness. The study will assess various patient characteristics to ensure compatibility with the stent graft system.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with descending thoracic aortic aneurysm or type B aortic dissection who require endovascular repair and meet specific anatomical criteria.

Not a fit: Patients who do not have a descending thoracic aortic aneurysm or type B aortic dissection, or those whose anatomy does not meet the device's requirements, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment options and improve outcomes for patients with thoracic aortic conditions.

How similar studies have performed: Other studies involving similar endovascular devices have shown promising results, indicating that this approach has potential based on previous successes.

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.

Where this trial is running

Bad Neustadt an der Saale and 7 other locations

• RHÖN-KLINIKUM Campus Bad Neustadt — Bad Neustadt an der Saale, Germany (Not_yet_recruiting)
• Asklepios Klinik Nord Heidberg — Hamburg, Germany (Recruiting)
• St. Franziskus Hospital Münster — Münster, Germany (Recruiting)
• Evaggelismos General Hospital — Athens, Greece (Recruiting)
• General Hospital of Athens - Georgios Gennimatas — Athens, Greece (Recruiting)
• University General Hospital - Attikon — Attiki, Greece (Recruiting)
• A.O. Ordine Mauriziano di Torino — Turin, Italy (Recruiting)
• Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre — Saint Petersburg, Russia (Recruiting)

Study contacts

• Study coordinator: Rae Gong

Conditions Aneurysm Thoracic; Dissection of Thoracic Aorta