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

NCT ID: NCT03116750

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2024-06-06

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Straub Medical AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medizinische Universität Graz

Graz, , Austria

Medizinische Universität Wien

Vienna, , Austria

CHU - Hôpital François-Mitterrand

Dijon, Bourgogne-Franche-Comté, France

Universitätsklinikum Aachen

Aachen, , Germany

Klinikum Arnsberg, Klinik für Angiologie

Arnsberg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock

Rostock, , Germany

Galway University Hospital

Galway, , Ireland

Azienda Ospedaliera San Giovanni Addolorata

Roma, , Italy

Countries

Austria; France; Germany; Ireland; Italy

Other Identifiers

15k013

Identifier Type: -

Identifier Source: org_study_id