Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System

Launched by PAUL J. GAGNE · Jun 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a device called the QuickClear Mechanical Thrombectomy System, which is used to help remove blood clots from the deep veins in the legs of patients suffering from a condition known as acute Deep Vein Thrombosis (DVT). This study is taking place in an office setting and aims to gather more information about how well this device works in real-world scenarios, after it has already been approved for use.

To participate in the trial, individuals must be between 18 and 89 years old, have experienced symptoms of DVT within the last 14 days, and be able to take medication as prescribed after the procedure. Participants will need to undergo a procedure to use the QuickClear system, and they will receive care and follow-up to monitor their recovery. It's important to note that certain health conditions may prevent someone from joining the study, such as severe bleeding problems or recent major surgeries. Overall, this trial aims to improve treatment options for patients with DVT and help them recover more effectively.

Gender

ALL

Eligibility criteria

• Inclusion 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)
• Exclusion Criteria:
• • 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)