RecruitingNCT05639569

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

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


Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrollment

145 participants

Start Date

May 3, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This post-market study follows patients who received (or will receive) the Ankura aortic stent graft — a device implanted inside the thoracic aorta to treat a thoracic aortic aneurysm (a dangerous bulge in the main chest artery) or type B aortic dissection (a tear in the artery wall). The study tracks safety and performance over 3 years after implantation. You may be eligible if... - You are 18 to 85 years old - You have a descending thoracic aortic aneurysm or type B aortic dissection requiring endovascular repair - Your life expectancy exceeds 1 year - You have appropriate anatomy for the Ankura device per manufacturer guidelines - You are willing to attend follow-up visits for 3 years You may NOT be eligible if... - You have a genetic connective tissue disease such as Marfan syndrome or Ehlers-Danlos syndrome - You have had a heart attack or stroke within the past 3 months - You have severe heart failure (NYHA class 3–4) or unstable angina - You are pregnant or planning to become pregnant - You are severely obese (over 150 kg) - You have an active systemic infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAnkura™ TAA Stent Graft System

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


Locations(8)

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

Asklepios Klinik Nord Heidberg

Hamburg, Germany

St. Franziskus Hospital Münster

Münster, Germany

Evaggelismos General Hospital

Athens, Greece

General Hospital of Athens - Georgios Gennimatas

Athens, Greece

University General Hospital - Attikon

Attiki, Greece

A.O. Ordine Mauriziano di Torino

Turin, Italy

Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre

Saint Petersburg, Russia

View Full Details on ClinicalTrials.gov

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NCT05639569


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