Clinical Safety, Feasibility, and Economic Viability of Performing Percutaneous Deep Vein Thrombectomy With the QuickClear Thrombectomy System in an Office Interventional Suite for Acute Lower Extremity Deep Vein Thrombosis (DVT)
A post-market study of the QuickClear Mechanical Thrombectomy system used for the removal of acute Deep Vein Thrombosis (DVT) from the deep veins of legs in the setting of an office interventional suite.
• Male or Non-Pregnant Female, age 18 to 89.
• 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.
• Onset of acute DVT symptoms of 14 days or less in the target limb.
• Ability to take oral medication and be willing to adhere to the prescribed anti- coagulant regiment.
• Occlusive DVT (confirmed by either venous duplex ultrasound or CT venogram) spanning at least one of the following:
‣ the iliac and/or common femoral vein. Extension into the femoral vein and/or profunda vein is allowed. OR
⁃ the entire popliteal vein (above and below knee). Extension into the femoral vein and/or tibial veins is allowed.
• People who have scheduled or will be scheduled for treatment with the QuickClear Mechanical Thrombectomy system
• Symptomatic DVT defined as meeting at least one of the following clinical indicators:
‣ rVCSS Pain Score ≥2
⁃ New edema of calf or thigh (CEAP ≥3)