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NCT05740410 Clinical Trial

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

Deep Vein Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05740410
Other study ID # ClotTriever
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2021
Est. completion date July 20, 2022

Study information
Verified date February 2023
Source Klinikum Arnsberg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date July 20, 2022
Est. primary completion date January 17, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - uni or bilateral iliofemoral DVT Exclusion Criteria: - previously stented in treatment vein

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ClotTriever Catheter
Treatment of iliofemoral deep vein thrombosis with the ClotTriever catheter

Locations
Country Name City State
Germany Klinikum Hochsauerland GmbH Arnsberg

Sponsors (1)
Lead Sponsor Collaborator
Klinikum Arnsberg

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Procedural success Restauration of inflow in the treated vein directly after treatment of the vein (Day 0)
Secondary Incidence of ClotTriever related major adverse events (MAE) MAEs defined as death, major amputation or any clinically driven target lesion revascularisation 1 month
Secondary 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 directly after treatment of the vein (Day 0)
Secondary 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). Day 0, month 1 and 6
Secondary Venous clinical severity score (VCSS) Score of 10 parameters each assessed by severity 0-3. Day 0, month 1 and 6
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