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

• Sponsor: Klinikum Arnsberg (Other)
• Overall Status: Completed
• CT.gov ID: NCT05740410
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 15.2
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis	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 Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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)
• Actual Study Start Date: Apr 12, 2021
• Actual Primary Completion Date: Jan 17, 2022
• Actual Study Completion Date: Jul 20, 2022

Outcome Measures

Primary Outcome Measures

1. Procedural success [directly after treatment of the vein (Day 0)]

   Restauration of inflow in the treated vein

Secondary Outcome Measures

1. Incidence of ClotTriever related major adverse events (MAE) [1 month]

   MAEs defined as death, major amputation or any clinically driven target lesion revascularisation

2. 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

3. 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).

4. Venous clinical severity score (VCSS) [Day 0, month 1 and 6]

   Score of 10 parameters each assessed by severity 0-3.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• uni or bilateral iliofemoral DVT

Exclusion Criteria:

• previously stented in treatment vein

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Hochsauerland GmbH	Arnsberg		Germany	59759

Sponsors and Collaborators

• Klinikum Arnsberg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Klinikum Arnsberg
• ClinicalTrials.gov Identifier: NCT05740410
• Other Study ID Numbers: ClotTriever
• First Posted: Feb 23, 2023
• Last Update Posted: Feb 23, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thrombosis; Venous Thrombosis

Study Results

No Results Posted as of Feb 23, 2023