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

Completed

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

• Registration Number: NCT03116750
• Lead Sponsor: Straub Medical AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-31
• Study Start: 2017-04-03
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-17
• Primary Completion: 2021-12-30
• Study Completion: 2024-06-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedural success (removal of occlusion and restoration of blood flow)	day of treatment	Primary patency

Secondary Outcome Measures

Name	Time	Method
Swelling of limb	through study completion of 3 years	Circumference of the limb
Hospital Stay	4-5 days after treatment	Duration of hospital stay
Adverse events	through study completion of 3 years	failure of usability
Adverse device effects	through study completion of 3 years	device related safety variables
Technical success rate	intraoperative	removal of occlusion
Pain improvement	through study completion of 3 years	pain disability index
additional Treatment , acute	before 72 hours after treatment	index treatment at index site
additional Treatment, Long term	later than 72 hours after treatment	index treatment at index site
Time to return back to ward	day of treatment	Treatment time

Trial Locations

Locations (9)

Medizinische Universität Wien; 🇦🇹 Wien, Austria

Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock; 🇩🇪 Rostock, Germany

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Azienda Ospedaliera San Giovanni Addolorata; 🇮🇹 Roma, Italy

Klinikum Arnsberg, Klinik für Angiologie; 🇩🇪 Arnsberg, Germany

Galway University Hospital; 🇮🇪 Galway, Ireland

CHU - Hôpital François-Mitterrand; 🇫🇷 Dijon, Bourgogne/Franche-Comté, France

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany