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

Deep Vein Thrombosis Clinical Trial

— P-MAX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03116750
• Other study ID #: 15k013
• Status: Active, not recruiting
• Start date: April 3, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: Straub Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bypass Complication
• Deep Vein Thrombosis
• Dialysis Shunt
• Stent Occlusion
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Austria	Medizinische Universität Wien	Wien
France	CHU - Hôpital François-Mitterrand	Dijon	Bourgogne/Franche-Comté
Germany	Universitätsklinikum Aachen	Aachen
Germany	Klinikum Arnsberg, Klinik für Angiologie	Arnsberg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock	Rostock
Ireland	Galway University Hospital	Galway
Italy	Azienda Ospedaliera San Giovanni Addolorata	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Straub Medical AG

Countries where clinical trial is conducted

Austria,  France,  Germany,  Ireland,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success (removal of occlusion and restoration of blood flow)	Primary patency	day of treatment
Secondary	Adverse events	failure of usability	through study completion of 3 years
Secondary	Adverse device effects	device related safety variables	through study completion of 3 years
Secondary	Technical success rate	removal of occlusion	intraoperative
Secondary	Swelling of limb	Circumference of the limb	through study completion of 3 years
Secondary	Pain improvement	pain disability index	through study completion of 3 years
Secondary	additional Treatment , acute	index treatment at index site	before 72 hours after treatment
Secondary	additional Treatment, Long term	index treatment at index site	later than 72 hours after treatment
Secondary	Hospital Stay	Duration of hospital stay	4-5 days after treatment
Secondary	Time to return back to ward	Treatment time	day of treatment