Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking

Официальное название

A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)

Обзор

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the Cleaner Vac® Thrombectomy System for the treatment of thrombus in patients with lower extremity proximal deep vein thrombosis (DVT). This prospective, multi-center, open-label study will assess clinical outcomes, device performance, and procedural success in a single DVT study cohort.

Вмешательства

• Устройство Aspiration thrombectomy system
  The Cleaner Vac® Thrombectomy System is a percutaneous mechanical aspiration thrombectomy device designed for the removal of fresh, soft thrombi and emboli from the peripheral venous vasculature. The system includes an aspiration canister with integrated pump, an 18F aspiration catheter, a handpiece with aspiration control lever, a dilator, and an optional flushing adapter. The device operates via controlled suction to extract thrombus and restore venous patency.

Первичные конечные точки

• Technical Success [Срок оценки: At the time of the index procedure]
• Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure [Срок оценки: 30 days post-index procedure]

Вторичные конечные точки (5)

• Freedom from Device- or Procedure-Related Serious Adverse Events (SAEs) [Срок оценки: 30 days post-procedure]
• Post-Thrombotic Syndrome Severity [Срок оценки: Up to 24 months]
• Venous patency [Срок оценки: From 30 days post-treatment to the end of the study period]
• Need for Target Vessel Reintervention [Срок оценки: From date of index procedure up to 24 months]
• Numeric Pain Rating Scale [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

Participants must meet all the following criteria to be eligible for the study:

• At least 18 years of age at the time of consent.
• Undergo frontline (primary) treatment with Cleaner Vac® Thrombectomy System in the peripheral venous vasculature and have at least one component introduced into the body.
• Written informed consent obtained through the IRB-approved ICF.

For the DVT cohort, participants must meet all criteria above and below to be eligible for the study:

• Present with unilateral or bilateral lower extremity DVT involving at least one of the following veins:

• Femoral-popliteal vein
• Common femoral vein
• Iliac vein
• Inferior Vena Cava (IVC)
• DVT diagnosis confirmed by imaging within 14 days of the index procedure.
• Symptomatic DVT with onset within 6 weeks of enrollment.

Критерии исключения

Subjects will be excluded from the study if any of the following criteria are met:

• Contraindication to systemic or therapeutic doses of anticoagulants.
• Contraindication to iodinated contrast that cannot be adequately premedicated.
• Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
• Patients that are pregnant.
• Known coagulation disorders both acquired (Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period.
• Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
• Known congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins.
• Known history of a Patent Foramen Ovale (PFO).
• Hemoglobin < 8.0 g/dL, INR > 2.0 before warfarin was started, or platelets < 50,000/µl which cannot be corrected prior to enrollment.
• Severe renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on dialysis. Patients with GFR <30 ml/min who are already on dialysis can be enrolled.
• Patients with intermediate-high risk or high-risk pulmonary embolism (PE) defined as follows:

• High-risk PE: Presence of hemodynamic instability, including cardiac arrest, obstructive shock (systolic blood pressure <90 mmHg or need for vasopressors with signs of end-organ hypoperfusion), or persistent hypotension (systolic BP <90 mmHg or a drop ≥40 mmHg for >15 minutes not due to other causes)
• Intermediate-high-risk PE: Hemodynamically stable patients with both right ventricular (RV) dysfunction (on echocardiography or CT) and elevated cardiac biomarkers (e.g., troponin).
• Complete infrarenal IVC occlusion.
• Chronic non-ambulatory status.
• Current enrollment in another investigational device or drug study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• Janna, LLC — Fort Lauderdale
• Baycare Health System — Tampa
• St. Elizabeth Healthcare - Edgewood — Edgewood
• Baylor Scott & White The Heart Hospital - Plano — Plano

Идентификаторы

NCT: NCT07102160 · CNPV01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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