NCT05740410

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

January 30, 2023

Last Update Submit

February 13, 2023

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Procedural success

    Restauration of inflow in the treated vein

    directly after treatment of the vein (Day 0)

Secondary Outcomes (4)

  • Incidence of ClotTriever related major adverse events (MAE)

    1 month

  • 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)

  • Vilallta score

    Day 0, month 1 and 6

  • Venous clinical severity score (VCSS)

    Day 0, month 1 and 6

Interventions

ClotTriever CatheterDEVICE

Treatment of iliofemoral deep vein thrombosis with the ClotTriever catheter

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients treated in the vascular center of the clinic

You may qualify if:

  • uni or bilateral iliofemoral DVT

You may not qualify if:

  • previously stented in treatment vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Michael H Lichtenberg, MD

    Klinikum Hochsauerland GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 23, 2023

Study Start

April 12, 2021

Primary Completion

January 17, 2022

Study Completion

July 20, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

It is not planned to share IPD

Locations

DE(1)