Observing patients with thoracoabdominal aortic aneurysm treated with a specific stent graft system
INNER-B - A 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 if a special stent graft can help prevent death in adults with thoracoabdominal aortic aneurysms over the next five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | JOTEC GmbH Industry-sponsored |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT04383145 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the E-nside TAAA Multibranch Stent Graft System in preventing death related to thoracoabdominal aortic aneurysms. Patients aged 18 to 85 with degenerative, atherosclerotic aneurysms will be treated with this endovascular device at the discretion of their physicians. Data will be collected over a period of approximately 60 months, including routine clinical observations and imaging evaluations. The study will ensure thorough verification of all collected data against existing clinical records.
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 with unsuitable anatomical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates for patients with thoracoabdominal aortic aneurysms.
How similar studies have performed: Other studies have shown success with similar endovascular approaches for treating aortic aneurysms, indicating a promising avenue for this treatment.
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 enrolment * Patient has untreated hyperthyroidism * Patient has a malignancy (progressive, stable or partial remission) with less than one-year projected survival * 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
Heidelberg
- Universitätsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
Study contacts
- Study coordinator: Mihail Georgiev
- Email: mihail.georgiev@artivion.com
- Phone: +49 151 15397693
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.