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.
Study Type
OBSERVATIONAL
Enrollment
25
Treatment of iliofemoral deep vein thrombosis with the ClotTriever catheter
Klinikum Hochsauerland GmbH
Arnsberg, Germany
Procedural success
Restauration of inflow in the treated vein
Time frame: directly after treatment of the vein (Day 0)
Incidence of ClotTriever related major adverse events (MAE)
MAEs defined as death, major amputation or any clinically driven target lesion revascularisation
Time frame: 1 month
Number of lesions with at least Society Interventional Radiology (SIR) Grad II Lyse (50-95% thrombus removal)
Society Interventional Radiology (SIR) Grad II Lyse (50-95 % thrombus removal) or greater at the end of the procedure including adjunctive treatments
Time frame: 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).
Time frame: Day 0, month 1 and 6
Venous clinical severity score (VCSS)
Score of 10 parameters each assessed by severity 0-3.
Time frame: Day 0, month 1 and 6
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