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Active, not recruitingNCT05928221Updated Feb 6, 2026

Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System

An observational study in Acute Deep Venous Thrombosis of Ileofemoral Vein, sponsored by Paul J. Gagne. Active, not recruiting at 6 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Paul J. Gagne · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 89 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Acute Deep Venous Thrombosis of Ileofemoral Vein
03

In context

Lead sponsor

This is the only study on the registry with Paul J. Gagne as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • DeviceThrombectomy

    removal of fresh soft emboli and thrombi from the vessels of the venous system

    Also known as: QuickClear Mechanical Thrombectomy system

06

What researchers measure

Primary outcomes

  1. Primary Device Effectiveness

    Extent of acute DVT removal overall and in each segment (Common Iliac Vein (CIV), External Iliac Vein (EIV), Common Femoral Vein (CFV), Profunda Femoris Vein (PFV), Femoral Vein (FV), Popliteal (POP) as measured by IVUS and Venography

    Time frame: Immediately after procedure

  2. Change in revised Venous Clinical Severity Score (rVCSS)

    Improvement of target leg revised Venous Clinical Severity Score (rVCSS) Scores range from 0= no disease to 30= severe disease. Change in the rVCSS score is calculated as the follow-up score minus the Baseline score . A negative change is associated with improved outcome

    Time frame: 30 days post index procedure

  3. Change in Villalta Score

    Improvement of the Villalta Score. Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, sever PTS. A negative change is associated with improved outcome.

    Time frame: 30 Days Post Index Procedure

  4. Change in EuroQol-5 Dimension (EQ-5D) Score

    Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0=worst health; 100= best health). A positive change is associated with improved outcome. Change in EQ-5D scores are calculated as the Follow-up minus the Baseline score.

    Time frame: 30 Days Post Index Procedure

  5. Primary Safety Endpoint

    Serious adverse event related to the device, study procedure or secondary procedure to maintain or re-establish patency

    Time frame: 12 months post index procedure

Secondary outcomes

  1. Total blood loss during procedure

    The total blood loss for the duration of the procedure will be determined by the volume of blood in the collection bag, measured in milliliters, at the end of the procedure.

    Time frame: immediately after index procedure

  2. Age of Deep Vein occlusive disease

    The Deep Vein occlusive disease will be categorized as one of the following depending on the age of the disease visualized during the procedure: Acute DVT, Acute DVT on chronic scar, chronic scar

    Time frame: immediately after the procedure

  3. Health Economics

    Analysis of procedural reimbursement versus procedural cost of treatment

    Time frame: 3 months post index procedure

  4. Primary patency

    Primary patency through 12 months of vein segments that were patent (\>50% lumen) at end of index procedure

    Time frame: 12 months post index procedure

  5. Assisted primary patency

    required reintervention to maintain patency

    Time frame: 12 months post index procedure

  6. Change in revised Venous Clinical Severity Score (rVCSS)

    Improvement of target leg rVCSS Scores range from 0= no disease to 30= severe disease. Change in the rVCSS score is calculated as the follow-up score minus the Baseline score . A negative change is associated with improved outcome

    Time frame: 12 months post index procedure

  7. Overall patient safety

    Adverse event tracking

    Time frame: 12 months post procedure

  8. Change in Villalta Score

    Improvement of the Villalta Score. Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, sever PTS. A negative change is associated with improved outcome.

    Time frame: 12 months post index procedure

  9. Change in EuroQol-5 Dimension (EQ-5D) Score

    Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0=worst health; 100= best health). A positive change is associated with improved outcome. Change in EQ-5D scores are calculated as the Follow-up minus the Baseline score.

    Time frame: 12 months post index procedure

07

Study locations

6 sites
  • Vascular Care Connecticut
    Darien, Connecticut 06820, United States
  • The Vascular Care Group
    Hyannis, Massachusetts 02601, United States
  • The Vascular Care Group
    Leominster, Massachusetts 01453, United States
  • The Vascular Care Group
    Plymouth, Massachusetts 02360, United States
  • The Vascular Care Group
    Wellesley, Massachusetts 02482, United States
  • The Vascular Care Group
    Worcester, Massachusetts 01605, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05928221
Lead sponsor
Paul J. Gagne
Responsible party
Paul J. Gagne (President, Vascular Breakthroughs, LLC, Vascular Care CT, PLLC) — Sponsor-investigator
First posted
Jul 3, 2023
Start date
Jun 14, 2023
Primary completion
May 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Feb 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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