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:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT03116750
Eligibility Criteria:
Inclusion Criteria:
1. Acute thrombotic or thromboembolic occlusion (onset of pain \< 14 days)
2. Age \> 18 years
3. Written informed consent form
Exclusion Criteria:
1. Patient not suitable for thrombectomy
2. Fracture area of broken stents
3. Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure
4. Persistent vasospasm
5. Severe coagulatory disorders
6. Patients with thrombophilia
7. Aneurysmatically altered vessel segments on target zone or on passage of catheter
8. Known or suspected infection, especially of the puncture site or the vessel segment being treated
9. Known, unhealed pre-existing mechanical damage to the vessel wall, especially caused by surgical procedures or interventional complications
10. Immature or not fully healed dialysis accesses or bypass grafts
11. Female subjects of childbearing capacity who are not willing to employ contraceptive measures
12. Pregnant or breast feeding subjects
13. Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with requirements of the study
14. Subjects who are lawfully kept in an institution
15. Subjects who do not have the mental or physical ability to comply with time schedules and further study procedures
16. Current participation in any other clinical study (medicinal, medical device) or within the last 30 days prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03116750
Study Brief:
Protocol Section:
NCT03116750