Actively Recruiting
Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2025-06-22
145
Participants Needed
8
Research Sites
399 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD) needing endovascular repair (TEVAR).
- Life expectancy greater than 1 year.
- Patient or legally authorized representative understands the trial, agrees to comply with a 3-year follow-up, and has signed informed consent.
- Patient characteristics meet Ankura™ Stent Graft System instructions for use and sizing guidelines:
- For DTA: Adequate iliac/femoral access vessel compatible with delivery system.
- Aortic inner diameter between 18 and 42 mm.
- At least 15 mm of non-aneurysmal aorta above and below the lesion.
- Suitable morphology for endovascular repair.
- For TBAD: Adequate iliac/femoral access vessel compatible with delivery system.
- At least 15 mm landing zone proximal and distal to primary entry tear, both not dissected.
- Diameter at proximal landing zone between 16 and 44 mm.
- Diameter at distal landing zone between 16 and 44 mm.
- Suitable morphology for endovascular repair.
You will not qualify if you...
- Contraindications in Ankura™ Stent Graft System instructions for use, including:
- Acute systemic infection.
- Other cardiovascular devices interfering with placement.
- Mesenteric blood flow mainly from inferior mesenteric artery.
- Allergic reaction to the device.
- Unsuitable vascular morphology for endovascular repair.
- Severe renal insufficiency or allergy to contrast agents.
- Aneurysm neck with thrombus.
- Non-aneurysmal aortic proximal neck length less than 1.5 cm.
- Non-aneurysmal aortic distal anchorage zone less than 1.5 cm.
- For aneurysms, non-aneurysmal aortic diameter less than 18 mm or greater than 42 mm.
- For Type B dissections, non-aneurysmal aortic diameter less than 16 mm or greater than 44 mm.
- Traumatic aortic injury.
- Uncorrectable coagulopathy.
- Hereditary connective tissue diseases such as Marfan or Ehlers-Danlos Syndromes.
- Morbid obesity over 350 pounds (150 kg) or inability to undergo accurate fluoroscopy due to obesity.
- Age under 18 or over 85 years.
- Pregnant, planning pregnancy, or breastfeeding.
- Myocardial infarction or stroke within 3 months before procedure.
- ASA Physical Status Classification of 5 or higher.
- Unstable angina or heart failure classified as NYHA 3 or 4.
- Participation in other drug or device clinical trials.
- Access vessels too tortuous, narrow, or unsuitable for device introduction.
- Any medical or anatomical condition making endovascular repair unsuitable per investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Germany
Not Yet Recruiting
2
Asklepios Klinik Nord Heidberg
Hamburg, Germany
Actively Recruiting
3
St. Franziskus Hospital Münster
Münster, Germany
Actively Recruiting
4
Evaggelismos General Hospital
Athens, Greece
Actively Recruiting
5
General Hospital of Athens - Georgios Gennimatas
Athens, Greece
Actively Recruiting
6
University General Hospital - Attikon
Attiki, Greece
Actively Recruiting
7
A.O. Ordine Mauriziano di Torino
Turin, Italy
Actively Recruiting
8
Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre
Saint Petersburg, Russia
Actively Recruiting
Research Team
R
Rae Gong
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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