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

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/orvenography ≥ 6 months prior to study screening.

• Persistent chronic deep vein Thrombosis causing restrictive flow, as confirmed byimaging, within 60 days prior to the study procedure.

• Failed a minimum of 3 consecutive months of conservative treatment (therapeuticanticoagulation 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 thrombolysisprocedure.

• 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 perInvestigator's discretion participant is able tolerate the procedure and becompliant 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). Ifcentral venous occlusion, consider computed tomography (CT) or magnetic resonancevenography (MRV). For participants with bilateral DVT, it is recommended thatcentral imaging be performed prior to treatment to evaluate the status of the IVC.

• Active bleeding, recent (<3 months) gastrointestinal (GI) bleeding, active pepticulcer, severe liver dysfunction, and bleeding diathesis.

• Recent (<3 months) internal eye surgery or hemorrhagic retinopathy; recent (<10days) 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 inthe 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 24hours prior to the procedure.

• Platelet count <100,000 cells/cubic millimeter (cells/mm^3) or >700,000 cells/mm^3within 24 hours prior to the procedure.

• Creatinine outside the normal range for the treating institution and consideredclinically 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 7days of the study procedure.

• In the judgment of the clinician, the participant is at high risk for catastrophicbleeding.

• Impossibility or refusal to give informed consent