Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System

Eligibility Criteria

• 1. Male or Non-Pregnant Female, age 18 to 89.
• 2. For females of reproductive potential: negative pregnancy test ≤ 7 days before the procedure, use of highly effective contraception (abstinence is acceptable) for 12 months after the study treatment.
• 3. Onset of acute DVT symptoms of 14 days or less in the target limb.
• 4. Ability to take oral medication and be willing to adhere to the prescribed anti- coagulant regiment.
• 5. Occlusive DVT (confirmed by either venous duplex ultrasound or CT venogram) spanning at least one of the following:
• 1. the iliac and/or common femoral vein. Extension into the femoral vein and/or profunda vein is allowed. OR
• 2. the entire popliteal vein (above and below knee). Extension into the femoral vein and/or tibial veins is allowed.
• 6. People who have scheduled or will be scheduled for treatment with the QuickClear Mechanical Thrombectomy system
• 7. Symptomatic DVT defined as meeting at least one of the following clinical indicators:
• 1. rVCSS Pain Score ≥2
• 2. New edema of calf or thigh (CEAP ≥3)
• 1. Non-ambulatory status prior to DVT occurrence.
• 2. Inability to lie in supine or prone under local anesthesia with moderate sedation for procedure.
• 3. In the contralateral (non-study) leg: symptomatic DVT that, in the operating physician's opinion, will require treatment in the following 30 days.
• 4. Critical limb ischemia with ulcer, gangrene, or rest pain (i.e., above symptoms or findings and ankle-brachial index \<0.5, absolute ankle pressure \<50 mm Hg or absolute toe pressure \<30 mmHg).
• 5. Pulmonary embolism (PE) defined as either massive (systolic blood pressure \< 90 mm Hg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management of PE. Low-risk PE and/or intermediate low-risk PE can be enrolled.
• 6. Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
• 7. Allergy, hypersensitivity, or thrombocytopenia from heparin, iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
• 8. History of, or active heparin-induced thrombocytopenia (HIT).
• 9. Hemoglobin ≤9.0 mg/dl, INR\>1.6 before starting anticoagulation, or platelets \< 100,000/ml. Moderate renal impairment in diabetic patients (eGFR \<60 ml/min) or severe renal impairment in non-diabetic patients (eGFR\< 30 ml/min).
• 10. Active bleeding, recent (\< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
• 11. Recent (\< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (\<10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, or other invasive procedure; or obstetrical delivery \< 72 hours prior to procedure.
• 12. History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
• 13. Active cancer with a life expectancy of \< 1 year.
• 14. Severe hypertension on repeated readings (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \>105 mmHg). This can be treated, and blood pressure must be stable before venous access is obtained (systolic blood pressure \< 150 mmHg, diastolic blood pressure \< 100 mm Hg).
• 15. Pregnant or breastfeeding or plans to become pregnant in the next 12 months.
• 16. Thrombus of the inferior vena cava (IVC) extending at least one centimeter above the common iliac vein confluence.
• 17. Inability to obtain venous access.
• 18. Contraindication to Enoxaparin (e.g., Severe chronic kidney injury, allergic reaction, HIT)