Bypass Complication, Deep Vein Thrombosis, Dialysis Shunt, Stent Occlusion
Conditions
Keywords
mechanical thrombectomy
Brief summary
The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral circulations. CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolizing procedures on the patient. ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed under real life setting.
Interventions
None listed
Sponsors
Straub Medical AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success (removal of occlusion and restoration of blood flow) | day of treatment | Primary patency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse device effects | through study completion of 3 years | device related safety variables |
| Technical success rate | intraoperative | removal of occlusion |
| Swelling of limb | through study completion of 3 years | Circumference of the limb |
| Pain improvement | through study completion of 3 years | pain disability index |
| Adverse events | through study completion of 3 years | failure of usability |
| additional Treatment, Long term | later than 72 hours after treatment | index treatment at index site |
| Hospital Stay | 4-5 days after treatment | Duration of hospital stay |
| Time to return back to ward | day of treatment | Treatment time |
| additional Treatment , acute | before 72 hours after treatment | index treatment at index site |
Countries
Austria, France, Germany, Ireland, Italy
Outcome results
None listed