Office-Based clot buster: new device aims to clear leg veins fast
NCT ID NCT05928221
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device called QuickClear that removes blood clots from the deep veins of the leg in people with acute deep vein thrombosis (DVT). The procedure is done in an office setting rather than a hospital. Researchers will check how well the device clears clots, improves leg symptoms, and affects quality of life, while also tracking safety. About 50 adults with recent DVT symptoms will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients who receive treatment with Philips QuickClear Mechanical Thrombectomy system in accordance with the current approved FDA indication for use as stated in the Instructions for Use (IFU) for acute lower extremity DVT.
- Ages
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18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Vascular Care Group
Hyannis, Massachusetts, 02601, United States
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The Vascular Care Group
Leominster, Massachusetts, 01453, United States
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The Vascular Care Group
Plymouth, Massachusetts, 02360, United States
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The Vascular Care Group
Wellesley, Massachusetts, 02482, United States
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The Vascular Care Group
Worcester, Massachusetts, 01605, United States
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Vascular Care Connecticut
Darien, Connecticut, 06820, United States