RecruitingNot Applicable

Inflow Improve for Deep Vein ThrombOsis with Ultrasound AcceLerated ThrombOlysis and Venoplasty

Italy50 participantsStarted 2024-01-29

Plain-language summary

Aim of the IDOLO study is to investigate clinical efficacy on ultrasound accelerated thrombolysis and venoplasty in patients with post-thrombotic syndrome secondary to chronical femoro-popliteal vein occlusion for previous deep vein Thrombosis (DVT). At San Raffaele Hospital (Vascular Surgery Department) will be enrolled 50 patients with lower extremity deep vein thrombosis (who have failed conservative treatment) objectively diagnosed with imaging ≥ 6 months; prior persistent deep vein Thrombosis (DVT) at enrollment evaluation and moderate-severe post-thrombotic syndrome at time of procedure

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient admitted in Vascular Surgery Unit, San Raffaele Hospital, Milan * Patients able to sign specific informed consent for the study. * Proximal deep vein Thrombosis (iliac vein, common femoral vein, deep femoral vein, and femoral vein) that was objectively diagnosed with duplex imaging and/or venography ≥ 6 months prior to study screening. * Persistent chronic deep vein Thrombosis causing restrictive flow, as confirmed by imaging, within 60 days prior to the study procedure. * Failed a minimum of 3 consecutive months of conservative treatment (therapeutic anticoagulation and compression stockings). * Villalta score ≥8 for the affected limb within 30 days prior to the study procedure Exclusion Criteria: * Treated with mechanical thrombectomy within 2 weeks of the study thrombolysis procedure. * Treated with thrombolysis drugs within 48 hours of the study thrombolytic procedure. * Life expectancy less than (\<) 1 year. * Body Mass Index (BMI) greater than (\>) 40 kilograms/square meter (kg/m\^2) or per Investigator's discretion participant is able tolerate the procedure and be compliant with post-procedure increased physical activity. * No flow in popliteal vein on duplex imaging * Thrombus extending ≥ 3 centimeters (cm) into the inferior vena cava (IVC). If central venous occlusion, consider computed tomography (CT) or magnetic resonance venography (MRV). For participants with bilateral DVT, it is recommended that central imaging be performed prior…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Severity Scores

Timeframe: up to 12 months

Major Bleeding

Timeframe: 72 hours

Trial details

NCT IDNCT06198816

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-15

Contact for this trial

Domenico Baccellieri, MD

+39022643 baccellieri.domenico@hsr.it

View on ClinicalTrials.gov More Post-Thrombotic Syndrome of Both Legs trials