Retrospective Analysis for the ClotTriever Catheter to Investigate Safety and Effectiveness in the Treatment of Acute and Subacute Iliofemoral Deep Vein Thrombosis (DVT)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05740410

Enrollment

Registered

2023-02-23

Start date

2021-04-12

Completion date

2022-07-20

Last updated

2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis

Brief summary

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)

Detailed description

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.

Interventions

DEVICEClotTriever Catheter

Treatment of iliofemoral deep vein thrombosis with the ClotTriever catheter

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* uni or bilateral iliofemoral DVT

Exclusion criteria

* previously stented in treatment vein

Design outcomes

Primary

Measure	Time frame	Description
Procedural success	directly after treatment of the vein (Day 0)	Restauration of inflow in the treated vein

Secondary

Measure	Time frame	Description
Incidence of ClotTriever related major adverse events (MAE)	1 month	MAEs defined as death, major amputation or any clinically driven target lesion revascularisation
Number of lesions with at least Society Interventional Radiology (SIR) Grad II Lyse (50-95% thrombus removal)	directly after treatment of the vein (Day 0)	Society Interventional Radiology (SIR) Grad II Lyse (50-95 % thrombus removal) or greater at the end of the procedure including adjunctive treatments
Vilallta score	Day 0, month 1 and 6	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).
Venous clinical severity score (VCSS)	Day 0, month 1 and 6	Score of 10 parameters each assessed by severity 0-3.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026