Improving treatment for post-thrombotic syndrome using ultrasound techniques

Inflow Improve for Deep Vein ThrombOsis with Ultrasound AcceLerated ThrombOlysis and Venoplasty: a Monocentric, Observational and Prospective Study.

This study is testing if using ultrasound to help clear blocked veins can relieve symptoms for people with post-thrombotic syndrome after a deep vein thrombosis.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: IRCCS San Raffaele (Academic / other)
• Locations: 1 site (Milan, Italy)
• Trial ID: NCT06198816 on ClinicalTrials.gov

What this trial studies

This study investigates the clinical efficacy of ultrasound accelerated thrombolysis and venoplasty in patients suffering from post-thrombotic syndrome due to chronic femoro-popliteal vein occlusion following deep vein thrombosis (DVT). A total of 50 patients with lower extremity DVT, who have not responded to conservative treatments, will be enrolled at San Raffaele Hospital in Milan. The study aims to assess the effectiveness of these interventions in alleviating symptoms and improving venous flow in affected limbs.

Who should consider this trial

Good fit: Ideal candidates are patients with chronic deep vein thrombosis and moderate to severe post-thrombotic syndrome who have failed conservative treatment.

Not a fit: Patients who have undergone recent mechanical thrombectomy or thrombolysis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from post-thrombotic syndrome.

How similar studies have performed: While similar approaches have been explored, this specific combination of ultrasound techniques for this condition is relatively novel.

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

Where this trial is running

Milan, Italy

• San Raffaele Hospital — Milan, Italy, Italy (Recruiting)

Study contacts

• Study coordinator: Domenico Baccellieri, MD

Conditions Post-Thrombotic Syndrome of Both Legs