Evaluating mechanical thrombectomy for deep vein thrombosis
Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems in a Monocentric, Observational Retrospective and Prospective Study (ASTER Study)
This study is testing if a procedure called mechanical thrombectomy can safely help people with serious blood clots in their legs feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06288906 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of mechanical thrombectomy in patients with symptomatic acute or subacute iliofemoral or caval deep vein thrombosis, diagnosed through CT imaging. It includes both retrospective and prospective data collection from patients admitted to the Vascular Surgery Unit. The study will follow standard clinical practices for treatment, including anticoagulation therapy prior to the procedure and monitoring of patients post-treatment. The focus is on understanding the effectiveness and safety of this intervention in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic acute or subacute iliofemoral or caval deep vein thrombosis who meet the inclusion criteria.
Not a fit: Patients who have been treated with thrombolysis drugs within 48 hours prior to the procedure or those with active bleeding conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options for patients suffering from deep vein thrombosis, potentially leading to better outcomes.
How similar studies have performed: Other studies have shown promising results with mechanical thrombectomy for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients admitted in the Unit of Vascular Surgery with proximal DVT (inferior vena cava, and/or iliac vein, and/or common femoral vein, and/or deep femoral vein, and/or femoral vein), according to ESVS guidelines (2022). Exclusion Criteria: * Patient treated with thrombolysis drugs within 48 hours prior to the index procedure * Active bleeding, recent (\<3 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis * Impossibility or refusal to give informed consent
Where this trial is running
Milan, Italy
- San Raffaele Hospital — Milan, Italy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.