Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT03918460
Eligibility Criteria:
Inclusion Criteria:
1. Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
2. An endoleak confirmed on a CT scan that should be done within 180 days prior to procedure but preferably within 90 days prior to screening demonstrating the high likelihood of the isolated nature of the endoleak; AND
3. An aneurysm sac growing after EVAR of minimal 10 mm (per European Guidelines) as documented in the preceding 90 days by means of CT-imaging (or alternative imaging techniques) and based upon sac diameter measurements; AND
4. An aneurysm sac that can be punctured via a translumbar approach; AND
5. Possibility to withhold anti-thrombogenic medication temporarily; AND
6. Ability and willingness to undergo the translumbar procedure; AND
7. Being older than 18 years.
Exclusion Criteria:
1. Patient not able or willing to give written Informed Consent; OR
2. Patient undergoing emergency procedures; OR
3. Patient with traumatic vascular injury; OR
4. Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
5. Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
6. Patient who is allergic to contrast media or anticoagulants; OR
7. Patient with renal impairment (eGFR \< 30 ml/min); OR
8. Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
9. Patient who is participating in another trial with an investigational drug or medical device, or where a medical device/drug is used outside its labelling and its approved intended use; OR
10. Pre-menopausal women, OR
11. Patient with a life expectancy of less than 12 months, OR
12. Patient with an intra aneurysm systolic blood pressure \> 125 mmHg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03918460
Study Brief:
Protocol Section:
NCT03918460