Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Deep Venous Thrombosis of Ileofemoral Vein
• Intervention / Treatment: Device: Thrombectomy

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Immediately after procedure
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	30 days post index procedure
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.	30 Days Post Index Procedure
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.	30 Days Post Index Procedure
Primary Safety Endpoint	Serious adverse event related to the device, study procedure or secondary procedure to maintain or re-establish patency	12 months post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	immediately after index procedure
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	immediately after the procedure
Health Economics	Analysis of procedural reimbursement versus procedural cost of treatment	3 months post index procedure
Primary patency	Primary patency through 12 months of vein segments that were patent (>50% lumen) at end of index procedure	12 months post index procedure
Assisted primary patency	required reintervention to maintain patency	12 months post index procedure
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	12 months post index procedure
Overall patient safety	Adverse event tracking	12 months post procedure
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.	12 months post index procedure
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.	12 months post index procedure

Collaborators and Investigators

• Sponsor: Paul J. Gagne

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Thrombectomy
• Other Study ID Numbers: CP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No