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)

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Device: ClotTriever Catheter

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany, 59759
    • Klinikum Hochsauerland GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients treated in the vascular center of the clinic

Description

Inclusion Criteria:

• uni or bilateral iliofemoral DVT

Exclusion Criteria:

• previously stented in treatment vein

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Restauration of inflow in the treated vein	directly after treatment of the vein (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ClotTriever related major adverse events (MAE)	MAEs defined as death, major amputation or any clinically driven target lesion revascularisation	1 month
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)
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
Venous clinical severity score (VCSS)	Score of 10 parameters each assessed by severity 0-3.	Day 0, month 1 and 6

Collaborators and Investigators

• Sponsor: Klinikum Arnsberg
• Investigators: Principal Investigator: Michael H Lichtenberg, MD, Klinikum Hochsauerland GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Estimate): February 23, 2023

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: ClotTriever

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not planned to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No