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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Deep Vein Thrombosis, Bypass Complication, Dialysis Shunt, Stent Occlusion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute thrombotic or thromboembolic occlusion (onset of pain < 14 days) Age > 18 years Written informed consent form Exclusion Criteria: Patient not suitable for thrombectomy Fracture area of broken stents 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 Persistent vasospasm Severe coagulatory disorders Patients with thrombophilia Aneurysmatically altered vessel segments on target zone or on passage of catheter Known or suspected infection, especially of the puncture site or the vessel segment being treated Known, unhealed pre-existing mechanical damage to the vessel wall, especially caused by surgical procedures or interventional complications Immature or not fully healed dialysis accesses or bypass grafts Female subjects of childbearing capacity who are not willing to employ contraceptive measures Pregnant or breast feeding subjects 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 Subjects who are lawfully kept in an institution Subjects who do not have the mental or physical ability to comply with time schedules and further study procedures Current participation in any other clinical study (medicinal, medical device) or within the last 30 days prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success (removal of occlusion and restoration of blood flow) | Primary patency | day of treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical thrombectomy