NCT03116750

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

Post-Market Clinical Follow-up Study with the ASPIREX®S Endovascular System to Assess the Safety and Effectiveness in the Treatment of DVT Patients and Special Patient Groups

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Straub Medical AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2017-04-03
• Primary completion: 2021-12-30
• Completion: 2024-06-06
• First posted: 2017-04-17
• Last updated: 2024-12-03

Locations

9 sites across 5 countries: Austria, France, Germany, Ireland, Italy