Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry.
Abdullah Shaikh, Adam Zybulewski, Joseph Paulisin...
https://pubmed.ncbi.nlm.nih.gov/37580422Actively Recruiting
Age: 18Years +
All Genders
ID06288906
Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems in a Monocentric, Observational Retrospective and Prospective Study
Led by IRCCS San Raffaele ยท Updated on 2025-05-01
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an observational, monocentric, retrospective and prospective research aimed at evaluating the feasibility of mechanical thrombectomy in adult patients with symptomatic acute or subacute iliofemoral or caval deep vein thrombosis (DVT). The condition is diagnosed with CT scan imaging, and the study follows clinical practice guidelines for patients with proximal DVT in veins such as the inferior vena cava, iliac vein, and femoral veins. Participants will undergo mechanical thrombectomy treatment after receiving anticoagulation therapy with enoxaparin sodium for at least 48 hours prior to the procedure. The access site for the procedure is chosen based on the extent of the blockage, with popliteal vein access used for single limb treatment. After the procedure, catheters are removed, pressure is applied to the insertion site, and pressure bandages are placed on both legs until hospital discharge. Anticoagulation therapy continues until discharge. During the study, participants will have duplex imaging and laboratory tests within 24 hours after treatment completion. Adverse events will be collected as part of the safety monitoring. The primary outcomes measured include the rate of technical success at the end of the procedure and the number of participants experiencing bleeding within 72 hours post-thrombectomy. All visits and procedures are conducted according to normal clinical practice, and the study is expected to run until December 2027.
CONDITIONS
Brief Title
Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults admitted to the Vascular Surgery Unit with proximal deep vein thrombosis in veins such as inferior vena cava, iliac vein, common femoral vein, deep femoral vein, or femoral vein
- Diagnosis according to ESVS guidelines (2022)
You will not qualify if you...
- Treatment with thrombolysis drugs within 48 hours before the procedure
- Active bleeding or recent gastrointestinal bleeding within the past 3 months
- Active peptic ulcer
- Severe liver dysfunction
- Bleeding diathesis
- Unable or unwilling to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within 24 hours prior to treatment
Participants undergo diagnostic imaging and laboratory tests to assess the extent of deep vein thrombosis and confirm eligibility for treatment.
1 visit (in-person)
Treatment
Duration - Single procedure day with anticoagulation starting at least 48 hours before
Participants receive mechanical thrombectomy of the caval and iliofemoral veins to remove blood clots, along with anticoagulation therapy initiated at least 48 hours prior to the procedure.
1 treatment visit (in-person)
Post-treatment Monitoring
Duration - Up to hospital discharge after treatment
Participants are monitored after treatment with duplex imaging, laboratory tests, and adverse event collection according to normal clinical practice until hospital discharge.
Approximately 1 to 2 visits (in-person)
Trial Site Locations
Total: 1 location
1
San Raffaele Hospital
Milan, Italy, Italy, 20132
Actively Recruiting
Loading map...
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis.
Michael A Jolly, Marie M Lockhart, Deep Shah...
https://pubmed.ncbi.nlm.nih.gov/35691538Mechanical Thrombectomy vs. Pharmacomechanical Catheter Directed Thrombolysis for the Treatment of Iliofemoral Deep Vein Thrombosis: A Propensity Score Matched Exploratory Analysis of 12 Month Clinical Outcomes.
Steven Abramowitz, Matthew C Bunte, Thomas S Maldonado...
https://pubmed.ncbi.nlm.nih.gov/37981003