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The aim of the study is to evaluate the safety and performance of the ClotTriever catheter in the treatment of patients with symptomatic iliofemoral deep vein thrombosis (DVT)
Data from patients in whom the ClotTriever catheter was used for treatment of iliofemoral DVT was retrospectively collected for up to 6 months after the procedure for evaluation of safety and effectiveness.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClotTriever Catheter | Device | Treatment of iliofemoral deep vein thrombosis with the ClotTriever catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Restauration of inflow in the treated vein | directly after treatment of the vein (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ClotTriever related major adverse events (MAE) | MAEs defined as death, major amputation or any clinically driven target lesion revascularisation | 1 month |
| Number of lesions with at least Society Interventional Radiology (SIR) Grad II Lyse (50-95% thrombus removal) |
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Inclusion Criteria:
Exclusion Criteria:
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patients treated in the vascular center of the clinic
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Lichtenberg, MD | Klinikum Hochsauerland GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Hochsauerland GmbH | Arnsberg | 59759 | Germany |
It is not planned to share IPD
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Society Interventional Radiology (SIR) Grad II Lyse (50-95 % thrombus removal) or greater at the end of the procedure including adjunctive treatments |
| directly after treatment of the vein (Day 0) |
| Vilallta score | Score for post thrombotic syndrome (PTS) assessing 5 subjective symptoms (pain, cramps, heaviness, paresthesia, pruritus) and 6 clinical signs (pretibial edema, skin induration, hyperpigmentation, redness, venous ectasia, pain on calf compression) with a 4-point scale from 0 (not present) to 3 (severe). | Day 0, month 1 and 6 |
| Venous clinical severity score (VCSS) | Score of 10 parameters each assessed by severity 0-3. | Day 0, month 1 and 6 |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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