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

Completed

• Conditions: Deep Vein Thrombosis

• Registration Number: NCT05740410
• Lead Sponsor: Klinikum Arnsberg

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.

Study Timeline

• Study Start: 2021-04-12
• Primary Completion: 2022-01-17
• Study Completion: 2022-07-20
• Study First Submitted: 2023-01-30
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-23
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• uni or bilateral iliofemoral DVT

Exclusion Criteria

• previously stented in treatment vein

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedural success	directly after treatment of the vein (Day 0)	Restauration of inflow in the treated vein

Secondary Outcome Measures

Name	Time	Method
Incidence of ClotTriever related major adverse events (MAE)	1 month	MAEs defined as death, major amputation or any clinically driven target lesion revascularisation
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.
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

Trial Locations

Locations (1)

Klinikum Hochsauerland GmbH; 🇩🇪 Arnsberg, Germany