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

Aneurysm Thoracic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639569
• Other study ID #: LT/TS/12C-2021-01
• Status: Recruiting
• Start date: December 26, 2022
• Est. completion date: December 30, 2027

Study information

• Verified date: April 2024
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: Rae Gong
• Phone: +86 18820162460
• Email: gongrui[@]lifetechmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The study is a multi-center, multi-national, prospective, observational, post-market clinical follow-up study conducted in 14 investigational centers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Thoracic
• Aortic Aneurysm, Thoracic
• Dissection of Thoracic Aorta

Intervention

Device:
• Ankura™ TAA Stent Graft Systems
All patients will be implanted with Ankura™ TAA Stent Graft Systems in accordance with the instructions for use (IFU).

Locations

Country	Name	City	State
Argentina	Hospital Espanol de Mendoza	Mendoza
Germany	Asklepios Klinik Nord Heidberg	Hamburg
Germany	St. Franziskus Hospital Münster	Muenster
Greece	Evaggelismos General Hospital	Athens
Greece	General Hospital of Athens - Georgios Gennimatas	Athens
Greece	University General Hospital - Attikon	Attikí
Italy	Hospital S. Martino	Genova
Italy	Hospital Mauriziano	Turin
Russian Federation	Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Countries where clinical trial is conducted

Argentina,  Germany,  Greece,  Italy,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse events	Incidence of major adverse events.	Timeframe: within 30-day post-implantation
Primary	Freedom from stent graft-related events	Freedom from stent graft-related events (12 months)	Timeframe: within 12-month post-implantation