Observational study on the E-nside TAAA Multibranch Stent Graft for treating thoracoabdominal aortic aneurysms
INNER-B-APAC - Asian Pacific Post-market Clinical Follow-up Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System
This study is testing a new stent graft to see if it is safe and effective for treating patients with thoracoabdominal aortic aneurysms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | JOTEC GmbH Industry-sponsored |
| Locations | 8 sites (Melbourne and 7 other locations) |
| Trial ID | NCT05954793 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System in patients with degenerative, atherosclerotic thoracoabdominal aortic aneurysms. Patients scheduled for treatment will be monitored, and their clinical data will be collected at various time points, including pre-operative planning, discharge, and follow-ups at 30 days, 3-6 months, and 12 months. The study will involve a thorough verification of patient information and outcomes, ensuring comprehensive data collection for analysis. The findings will contribute to understanding the effectiveness of this endovascular treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with degenerative, atherosclerotic thoracoabdominal aortic aneurysms who meet specific anatomical criteria.
Not a fit: Patients with allergies to materials necessary for endovascular repair or those who do not meet the anatomical criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of endovascular treatments for thoracoabdominal aortic aneurysms.
How similar studies have performed: Other studies have shown promising results with similar endovascular approaches, indicating potential for success in this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is between 18 and 85 years old * Patient has a degenerative, atherosclerotic thoracoabdominal aortic aneurysm * Patient has adequate iliac/femoral access compatible with an 8.5 mm OD delivery system * Patient's aorta has no distinct angulation in the thoracovisceral segment of the aorta ranging from 40 mm proximal to the celiac trunk to 20 mm distal to the lowest renal artery * All target branch vessels are suitable for antegrade cannulation * Diameter of the landing zone in each branch vessel to be treated is ≥ 5 mm * Length of landing zone in each branch vessel to be treated is ≥ 15 mm (preferably ≥ 20 mm) * Patient must be available for the appropriate follow-up times for the duration of the study * Patient has signed the informed consent before implantation of the E-nside Stent Graft Exclusion Criteria: * Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium) * Patient has systemic infection or suspected systemic infection * Patient has an infectious aneurysm * Patient has an inflammatory aneurysm * Patient has a ruptured aneurysm * Patient has a traumatic aneurysm * Patient has a symptomatic aneurysm * Patient has an aortic dissection * Patient has a congenital degenerative collagen disease or connective tissue disorder * Diameter of ostium of branch vessel to be treated \< 4 mm * Patient has thrombocytopenia (platelet count \< 150000/μl) * Patient has an eGFR \< 30 ml/min/1.73m2 before the intervention * Patient has untreated hyperthyroidism * Patient has a malignancy (progressive, stable or partial remission) * Patient had a myocardial infarction or cerebrovascular accident \< 3 months ago * Patient is planned to be treated with a chimney in the left subclavian artery * Patient has had a previous surgical repair of descending thoracic aorta * Patient will be treated or had been treated with a Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) or Anaconda (Vascutek) stent graft * Patient is enrolled or plans to be enrolled in another clinical study * Patient is pregnant or breastfeeding or planning to become pregnant during the course of the study. * Patient has a life expectancy of less than 3 years
Where this trial is running
Melbourne and 7 other locations
- Alfred Health — Melbourne, Australia (Not_yet_recruiting)
- Sir Charles Gairdner Hospital — Perth, Australia (Not_yet_recruiting)
- Royal North Shore Hospital — Saint Leonards, Australia (Not_yet_recruiting)
- Gold Coast University Hospital — Southport, Australia (Not_yet_recruiting)
- Auckland City Hospital — Auckland, New Zealand (Recruiting)
- Waikato Hospital Hamilton — Hamilton, New Zealand (Recruiting)
- Siriraj Hospital — Bangkok, Thailand (Recruiting)
- Prince of Songkla University - Songklanagarind Hospital — Songkhla, Thailand (Recruiting)
Study contacts
- Study coordinator: Mihail Georgiev
- Email: mihail.georgiev@artivion.com
- Phone: +4915115397693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.