Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems
Status: Not yet recruiting

This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient admitted in Unit of Vascular Surgery, San Raffaele Hospital, Milan Patients able to sign specific informed consent for the study Age 18 years to 75 years Proximal DVT (inferior vena cava, iliac vein, common femoral vein, deep femoral vein, and femoral vein) that was objectively diagnosed with CT scan Symptomatic DVT (pain, neurological deficit) or imparement of the tissue perfusion (phlegmasia) Diagnosis of the DVT since 1 month prior to the index procedure  Exclusion Criteria:  Patient treated with mechanical thrombectomy in the two week prior to the index procedure Patient treated with thrombolysis drugs within 48 hours prior to the index 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. 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 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Up to 50 patients (about 10 cases retrospective and 40 cases prospective) with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging. - SamplingMethod: Non-Probability Sample