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

NCT05639569 | Recruiting

• 1 other identifier: LT/TS/12C-2021-01
• Study Type: observational
• Target: 145
• Locations: 4 countries
• Sites: 8

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).

Conditions

Aneurysm Thoracic; Dissection of Thoracic Aorta

Outcome Measures

Primary Outcomes (2)

• Incidence of major adverse events

  Incidence of major adverse events.

  Timeframe: within 30-day post-implantation

• Freedom from stent graft-related events

  Freedom from stent graft-related events (12 months)

  Timeframe: within 12-month post-implantation

Study Arms (1)

Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD)

All patients who signed informed consent and are used with Ankura™ TAA Stent Graft Systems will undergo follow-up (FU) evaluations as per local hospital standards and corresponding IFU which is expected to be at the following time points post-implant: Before discharge, 30days after the procudure, 3-6 months after the Procedure, 12 months after the procedure, 24 months after the procedure, 36 months after the procedure

Device: Ankura™ TAA Stent Graft System

Interventions

Ankura™ TAA Stent Graft System DEVICE

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

Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (8)

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

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome

Central Study Contacts

Rae Gong

CONTACT

+86 18820162460; gongrui@lifetechmed.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 6, 2022
• Study Start: May 3, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2030
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); IT (1); GR (3); RU (1)