Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System (NCT05928221) | Clinical Trial Compass
Active — 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 range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Non-ambulatory status prior to DVT occurrence.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Device Effectiveness
Timeframe: Immediately after procedure
2
Change in revised Venous Clinical Severity Score (rVCSS)
. Inability to lie in supine or prone under local anesthesia with moderate sedation for procedure.
. In the contralateral (non-study) leg: symptomatic DVT that, in the operating physician's opinion, will require treatment in the following 30 days.
. 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).
. 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.
. Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
. Allergy, hypersensitivity, or thrombocytopenia from heparin, iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
. History of, or active heparin-induced thrombocytopenia (HIT).