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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 February 2023
• Main ID: NCT03116750
• Date of registration: 31/03/2017
• Prospective Registration: Yes
• Primary sponsor: Straub Medical AG
• Public title: Post-Market Clinical Follow-up Study With ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT P-MAX
• Scientific 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
• Date of first enrolment: April 3, 2017
• Target sample size: 81
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03116750
• Study type: Observational

Countries of recruitment

Austria, France, Germany, Ireland, Italy

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bypass Complication

Deep Vein Thrombosis

Dialysis Shunt

Stent Occlusion

Primary Outcome(s)

Procedural success (removal of occlusion and restoration of blood flow) [Time Frame: day of treatment]

Secondary Outcome(s)

Swelling of limb [Time Frame: through study completion of 3 years]

Time to return back to ward [Time Frame: day of treatment]

Adverse events [Time Frame: through study completion of 3 years]

additional Treatment, Long term [Time Frame: later than 72 hours after treatment]

Hospital Stay [Time Frame: 4-5 days after treatment]

Pain improvement [Time Frame: through study completion of 3 years]

Technical success rate [Time Frame: intraoperative]

additional Treatment , acute [Time Frame: before 72 hours after treatment]

Adverse device effects [Time Frame: through study completion of 3 years]

Secondary ID(s)

15k013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors