NCT06198816 Inflow Improve for Deep Vein ThrombOsis with Ultrasound AcceLerated ThrombOlysis and Venoplasty
| NCT ID | NCT06198816 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Post-Thrombotic Syndrome of Both Legs |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-29 |
| Primary Completion | 2026-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-01-29 with a primary completion date of 2026-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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 to treatment to evaluate the status of the IVC. * Active bleeding, recent (\<3 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis. * Recent (\<3 months) internal eye surgery or hemorrhagic retinopathy; recent (\<10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation (CPR), obstetrical delivery, or other invasive procedure. * History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, or aneurysm. * Active cancer (metastatic, progressive, or treated within the last 6 months). Participants with non-melanoma primary skin cancers are eligible to participate in the study. * Hemoglobin \<9.0 milligrams/deciliter (mg/dL) within 24 hours prior to the procedure * International normalized ratio (INR) ≥1.5 nanograms/deciliter (ng/dL) within 24 hours prior to the procedure. * Platelet count \<100,000 cells/cubic millimeter (cells/mm\^3) or \>700,000 cells/mm\^3 within 24 hours prior to the procedure. * Creatinine outside the normal range for the treating institution and considered clinically significant by the Investigator. * Uncontrolled hypertension, defined as systolic \>175 millimeters of mercury (mmHg) and a diastolic \>110 mmHg. * Use of clopidogrel, ticlopidine, or other thienopyridine antiplatelet drug within 7 days of the study procedure. * In the judgment of the clinician, the participant is at high risk for catastrophic bleeding. * Impossibility or refusal to give informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06198816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Post-Thrombotic Syndrome of Both Legs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06198816 currently recruiting?
Yes, NCT06198816 is actively recruiting participants. Contact the research team at baccellieri.domenico@hsr.it for enrollment information.
Where is the NCT06198816 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06198816 clinical trial?
NCT06198816 is sponsored by IRCCS San Raffaele. The trial plans to enroll 50 participants.