Using the QuickClear system to treat acute deep vein thrombosis

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)

This study is testing a new device called QuickClear to see if it can safely and effectively remove blood clots from the deep veins in the legs of patients with acute deep vein thrombosis.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: Vascular Care CT, PLLC (Academic / other)
• Locations: 6 sites (Darien, Connecticut and 5 other locations)
• Trial ID: NCT05928221 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the QuickClear Mechanical Thrombectomy system for removing acute deep vein thrombosis (DVT) from the deep veins of the legs in an office-based interventional suite. It aims to assess the long-term safety and effectiveness of the device while exploring the feasibility of performing thrombectomy procedures in such settings. Patients with symptomatic occlusive DVT will be treated according to the device's instructions for use, and their outcomes will be monitored over time.

Who should consider this trial

Good fit: Ideal candidates include males and non-pregnant females aged 18 to 89 with acute DVT symptoms of 14 days or less.

Not a fit: Patients with chronic DVT or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients suffering from acute DVT, potentially leading to better outcomes and reduced complications.

How similar studies have performed: While this approach is being assessed in a post-market setting, similar mechanical thrombectomy systems have shown promise in previous studies.

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)

Where this trial is running

Darien, Connecticut and 5 other locations

• Vascular Care Connecticut — Darien, Connecticut, United States (Recruiting)
• The Vascular Care Group — Hyannis, Massachusetts, United States (Recruiting)
• The Vascular Care Group — Leominster, Massachusetts, United States (Not_yet_recruiting)
• The Vascular Care Group — Plymouth, Massachusetts, United States (Recruiting)
• The Vascular Care Group — Wellesley, Massachusetts, United States (Recruiting)
• The Vascular Care Group — Worcester, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Maria Myslinski, RN

Conditions Acute Deep Venous Thrombosis of Ileofemoral Vein