Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System

Last updated: August 23, 2024
Sponsor: Paul J. Gagne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Claudication

Venous Thromboembolism

Treatment

Thrombectomy

Clinical Study ID

NCT05928221
CP-001
  • Ages 18-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or Non-Pregnant Female, age 18 to 89.

  2. For females of reproductive potential: negative pregnancy test ≤ 7 days before theprocedure, use of highly effective contraception (abstinence is acceptable) for 12months 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) spanningat least one of the following:

  6. the iliac and/or common femoral vein. Extension into the femoral vein and/orprofunda vein is allowed. OR

  7. the entire popliteal vein (above and below knee). Extension into the femoralvein and/or tibial veins is allowed.

  8. People who have scheduled or will be scheduled for treatment with the QuickClearMechanical Thrombectomy system

  9. Symptomatic DVT defined as meeting at least one of the following clinicalindicators:

  10. rVCSS Pain Score ≥2

  11. New edema of calf or thigh (CEAP ≥3)

Exclusion

Exclusion Criteria:

  1. Non-ambulatory status prior to DVT occurrence.

  2. Inability to lie in supine or prone under local anesthesia with moderate sedationfor procedure.

  3. In the contralateral (non-study) leg: symptomatic DVT that, in the operatingphysician's opinion, will require treatment in the following 30 days.

  4. Critical limb ischemia with ulcer, gangrene, or rest pain (i.e., above symptoms orfindings and ankle-brachial index <0.5, absolute ankle pressure <50 mm Hg orabsolute toe pressure <30 mmHg).

  5. Pulmonary embolism (PE) defined as either massive (systolic blood pressure < 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), orintermediate high-risk PE, as defined by the European Society Guideline onmanagement of PE. Low-risk PE and/or intermediate low-risk PE can be enrolled.

  6. Inability to tolerate contemporary venous intervention procedure due to severedyspnea 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 beused.

  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) orsevere renal impairment in non-diabetic patients (eGFR< 30 ml/min).

  10. Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleedingdiathesis.

  11. Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (<10 days)major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, or otherinvasive procedure; or obstetrical delivery < 72 hours prior to procedure.

  12. History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascularmalformation, aneurysm.

  13. Active cancer with a life expectancy of < 1 year.

  14. Severe hypertension on repeated readings (systolic blood pressure > 180 mm Hg ordiastolic blood pressure >105 mmHg). This can be treated, and blood pressure must bestable 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 thecommon iliac vein confluence.

  17. Inability to obtain venous access.

  18. Contraindication to Enoxaparin (e.g., Severe chronic kidney injury, allergicreaction, HIT)

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Thrombectomy
Phase:
Study Start date:
June 14, 2023
Estimated Completion Date:
March 31, 2026

Study Description

The QuickClear Mechanical Thrombectomy system will be used in accordance with the Instruction for Use (IFU) to remove acute, symptomatic occlusive common femoral, external iliac or common iliac DVT or occlusive above and below knee popliteal DVT in an office based interventional suite. The intent of this post-market observational study is to further assess long-term safety and effectiveness of patients treated with the QuickClear Mechanical Thrombectomy system and to assess the feasibility of performing deep vein thrombectomy procedures in the office interventional suite.

Connect with a study center

  • Vascular Care Connecticut

    Darien, Connecticut 06820
    United States

    Active - Recruiting

  • The Vascular Care Group

    Hyannis, Massachusetts 02601
    United States

    Active - Recruiting

  • The Vascular Care Group

    Leominster, Massachusetts 01453
    United States

    Site Not Available

  • The Vascular Care Group

    Plymouth, Massachusetts 02360
    United States

    Active - Recruiting

  • The Vascular Care Group

    Wellesley, Massachusetts 02482
    United States

    Active - Recruiting

  • The Vascular Care Group

    Worcester, Massachusetts 01605
    United States

    Active - Recruiting

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