Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System

Recruiting

• Conditions: Acute Deep Venous Thrombosis of Ileofemoral Vein

• Registration Number: NCT05928221
• Lead Sponsor: Paul J. Gagne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-6-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Male or Non-Pregnant Female, age 18 to 89.<br><br> 2. For females of reproductive potential: negative pregnancy test = 7 days before the<br> procedure, use of highly effective contraception (abstinence is acceptable) for 12<br> months after the study treatment.<br><br> 3. Onset of acute DVT symptoms of 14 days or less in the target limb.<br><br> 4. Ability to take oral medication and be willing to adhere to the prescribed anti-<br> coagulant regiment.<br><br> 5. Occlusive DVT (confirmed by either venous duplex ultrasound or CT venogram) spanning<br> at least one of the following:<br><br> 1. the iliac and/or common femoral vein. Extension into the femoral vein and/or<br> profunda vein is allowed. OR<br><br> 2. the entire popliteal vein (above and below knee). Extension into the femoral<br> vein and/or tibial veins is allowed.<br><br> 6. People who have scheduled or will be scheduled for treatment with the QuickClear<br> Mechanical Thrombectomy system<br><br> 7. Symptomatic DVT defined as meeting at least one of the following clinical<br> indicators:<br><br> 1. rVCSS Pain Score =2<br><br> 2. New edema of calf or thigh (CEAP =3)<br><br>Exclusion Criteria:<br><br> 1. Non-ambulatory status prior to DVT occurrence.<br><br> 2. Inability to lie in supine or prone under local anesthesia with moderate sedation<br> for procedure.<br><br> 3. In the contralateral (non-study) leg: symptomatic DVT that, in the operating<br> physician's opinion, will require treatment in the following 30 days.<br><br> 4. Critical limb ischemia with ulcer, gangrene, or rest pain (i.e., above symptoms or<br> findings and ankle-brachial index <0.5, absolute ankle pressure <50 mm Hg or<br> absolute toe pressure <30 mmHg).<br><br> 5. Pulmonary embolism (PE) defined as either massive (systolic blood pressure < 90 mm<br> Hg and/or patient on IV vasoactive medication to support blood pressure), or<br> intermediate high-risk PE, as defined by the European Society Guideline on<br> management of PE. Low-risk PE and/or intermediate low-risk PE can be enrolled.<br><br> 6. Inability to tolerate contemporary venous intervention procedure due to severe<br> dyspnea or acute systemic illness.<br><br> 7. Allergy, hypersensitivity, or thrombocytopenia from heparin, iodinated contrast,<br> except for mild-moderate contrast allergies for which steroid pre-medication can be<br> used.<br><br> 8. History of, or active heparin-induced thrombocytopenia (HIT).<br><br> 9. Hemoglobin =9.0 mg/dl, INR>1.6 before starting anticoagulation, or platelets <<br> 100,000/ml. Moderate renal impairment in diabetic patients (eGFR <60 ml/min) or<br> severe renal impairment in non-diabetic patients (eGFR< 30 ml/min).<br><br> 10. Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding<br> diathesis.<br><br> 11. Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (<10 days)<br> major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, or other<br> invasive procedure; or obstetrical delivery < 72 hours prior to procedure.<br><br> 12. History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascular<br> malformation, aneurysm.<br><br> 13. Active cancer with a life expectancy of < 1 year.<br><br> 14. Severe hypertension on repeated readings (systolic blood pressure > 180 mm Hg or<br> diastolic blood pressure >105 mmHg). This can be treated, and blood pressure must be<br> stable before venous access is obtained (systolic blood pressure < 150 mmHg,<br> diastolic blood pressure < 100 mm Hg).<br><br> 15. Pregnant or breastfeeding or plans to become pregnant in the next 12 months.<br><br> 16. Thrombus of the inferior vena cava (IVC) extending at least one centimeter above the<br> common iliac vein confluence.<br><br> 17. Inability to obtain venous access.<br><br> 18. Contraindication to Enoxaparin (e.g., Severe chronic kidney injury, allergic<br> reaction, HIT)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational [Patient Registry]
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Device Effectiveness;Change in revised Venous Clinical Severity Score (rVCSS);Change in Villalta Score;Change in EuroQol-5 Dimension (EQ-5D) Score;Primary Safety Endpoint

Secondary Outcome Measures

Name	Time	Method
Total blood loss during procedure;Age of Deep Vein occlusive disease;Health Economics;Primary patency;Assisted primary patency;Change in revised Venous Clinical Severity Score (rVCSS);Overall patient safety;Change in Villalta Score;Change in EuroQol-5 Dimension (EQ-5D) Score