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Completed

NCT Number: NCT05740410

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

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)

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • uni or bilateral iliofemoral DVT

Exclusion criteria

  • previously stented in treatment vein

Treatment and study plan

ClotTriever Catheter

Device

Treatment of iliofemoral deep vein thrombosis with the ClotTriever catheter

Primary outcomes

  1. Procedural success

    Time frame: directly after treatment of the vein (Day 0)

    Restauration of inflow in the treated vein

Secondary outcomes

  1. Incidence of ClotTriever related major adverse events (MAE)

    Time frame: 1 month

    MAEs defined as death, major amputation or any clinically driven target lesion revascularisation

  2. Number of lesions with at least Society Interventional Radiology (SIR) Grad II Lyse (50-95% thrombus removal)

    Time frame: 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

  3. Vilallta score

    Time frame: 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).

  4. Venous clinical severity score (VCSS)

    Time frame: Day 0, month 1 and 6

    Score of 10 parameters each assessed by severity 0-3.

Sponsors and collaborators

Lead sponsor

Klinikum Arnsberg

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2023
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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