Post-Market Clinical Follow-up Study with ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT (P-MAX)

Straub Medical

Status: Completed

Conditions: Stent Occlusion; Bypass Complication; Deep Vein Thrombosis; Dialysis Shunt

Study type: Observational

Funder types: Industry

Identifiers

NCT03116750

15k013

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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