Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System (NCT05928221) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System
United States50 participantsStarted 2023-06-14
Plain-language summary
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.
Who can participate
Age range18 Years ā 89 Years
SexALL
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Inclusion criteria
ā. Male or Non-Pregnant Female, age 18 to 89.
ā. For females of reproductive potential: negative pregnancy test ā¤ 7 days before the procedure, use of highly effective contraception (abstinence is acceptable) for 12 months after the study treatment.
ā. Onset of acute DVT symptoms of 14 days or less in the target limb.
ā. Ability to take oral medication and be willing to adhere to the prescribed anti- coagulant regiment.
ā. Occlusive DVT (confirmed by either venous duplex ultrasound or CT venogram) spanning at least one of the following:
ā. the iliac and/or common femoral vein. Extension into the femoral vein and/or profunda vein is allowed. OR
ā. the entire popliteal vein (above and below knee). Extension into the femoral vein and/or tibial veins is allowed.
ā. People who have scheduled or will be scheduled for treatment with the QuickClear Mechanical Thrombectomy system
Exclusion criteria
ā. Non-ambulatory status prior to DVT occurrence.
ā. Inability to lie in supine or prone under local anesthesia with moderate sedation for procedure.
ā. In the contralateral (non-study) leg: symptomatic DVT that, in the operating physician's opinion, will require treatment in the following 30 days.
ā
What they're measuring
1
Primary Device Effectiveness
Timeframe: Immediately after procedure
2
Change in revised Venous Clinical Severity Score (rVCSS)
. 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).
ā. 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.
ā. Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
ā. Allergy, hypersensitivity, or thrombocytopenia from heparin, iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
ā. History of, or active heparin-induced thrombocytopenia (HIT).