Clinical trial NCT05639569: Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study
Official title: Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study: Multi-center, Prospective, Observational, Post-Market Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysm Thoracic
Dissection of Thoracic Aorta
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-06
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) and indicate for endovascular repair (TEVAR).

Brief summary: The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD).


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.

Primary outcomes:
measure: Incidence of major adverse events
timeFrame: Timeframe: within 30-day post-implantation
measure: Freedom from stent graft-related events
timeFrame: Timeframe: within 12-month post-implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Neustadt An Der Saale
country: Germany
facility: RHÖN-KLINIKUM Campus Bad Neustadt
city: Hamburg
country: Germany
facility: Asklepios Klinik Nord Heidberg
city: Muenster
country: Germany
facility: St. Franziskus Hospital Münster
city: Athens
country: Greece
facility: Evaggelismos General Hospital
city: Athens
country: Greece
facility: General Hospital of Athens - Georgios Gennimatas
city: Attikí
country: Greece
facility: University General Hospital - Attikon
city: Turin
country: Italy
facility: A.O. Ordine Mauriziano di Torino
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre
Study officials:
References: