Clinical trial NCT03116750: Post-Market Clinical Follow-up Study with ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Bypass Complication
Dialysis Shunt
Stent Occlusion
Keywords: mechanical thrombectomy
Lead sponsor: Straub Medical AG
Sponsor class: INDUSTRY
First posted: 2017-04-17
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Main study population: patients with DVT of the pelvis, legs and vena cava inferior.

Additional patients with dialysis shunts and / or other bypasses, vena subclavia, vena brachiocephalica, vena cava superior, vena splenica and vena mesenterica superior/inferior will be included

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.


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

Primary outcomes:
measure: Procedural success (removal of occlusion and restoration of blood flow)
timeFrame: day of treatment
Secondary outcomes:
measure: Adverse events
timeFrame: through study completion of 3 years
measure: Adverse device effects
timeFrame: through study completion of 3 years
measure: Technical success rate
timeFrame: intraoperative
measure: Swelling of limb
timeFrame: through study completion of 3 years
measure: Pain improvement
timeFrame: through study completion of 3 years
measure: additional Treatment , acute
timeFrame: before 72 hours after treatment
measure: additional Treatment, Long term
timeFrame: later than 72 hours after treatment
measure: Hospital Stay
timeFrame: 4-5 days after treatment
measure: Time to return back to ward
timeFrame: day of treatment
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Dijon
country: France
facility: CHU - Hôpital François-Mitterrand
state: Bourgogne/Franche-Comté
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg, Klinik für Angiologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Rostock
country: Germany
facility: Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock
city: Galway
country: Ireland
facility: Galway University Hospital
city: Roma
country: Italy
facility: Azienda Ospedaliera San Giovanni Addolorata
Study officials:
References: