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CompletedNCT05740410Updated Feb 23, 2023

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

An observational study in Deep Vein Thrombosis, sponsored by Klinikum Arnsberg. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by Klinikum Arnsberg · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
25
Ages
18 Years and older
Sex
All
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Study 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)

Read the 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.

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Conditions studied

  • Deep Vein Thrombosis
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In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 25 is below the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Klinikum Arnsberg is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

patients treated in the vascular center of the clinic

Inclusion criteria

  • uni or bilateral iliofemoral DVT

Exclusion criteria

Exclusion Criteria:

  • previously stented in treatment vein
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
25 participants (actual)
Patient registry
No

Interventions

  • DeviceClotTriever Catheter

    Treatment of iliofemoral deep vein thrombosis with the ClotTriever catheter

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What researchers measure

Primary outcomes

  1. Procedural success

    Restauration of inflow in the treated vein

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

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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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Study locations

1 site
  • Klinikum Hochsauerland GmbH
    Arnsberg, 59759, Germany
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References and documents

Individual participant data

Plan to share: No — It is not planned to share IPD

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05740410
Lead sponsor
Klinikum Arnsberg
Responsible party
Sponsor
First posted
Feb 23, 2023
Start date
Apr 12, 2021
Primary completion
Jan 17, 2022
Completion
Jul 20, 2022
Last update
Feb 23, 2023

Study contacts

Michael H Lichtenberg, MD
principal investigator · Klinikum Hochsauerland GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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