Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System

NCT05928221 | Active Not Recruiting FDA Device

• 1 other identifier: CP-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Acute Deep Venous Thrombosis of Ileofemoral Vein

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Total blood loss during procedure

  immediately after index procedure

• Age of Deep Vein occlusive disease

  immediately after the procedure

• Health Economics

  3 months post index procedure

• Primary patency

  12 months post index procedure

• Assisted primary patency

  12 months post index procedure

Interventions

Thrombectomy DEVICE

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

Also known as: QuickClear Mechanical Thrombectomy system

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or Non-Pregnant Female, age 18 to 89.
• 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.
• Onset of acute DVT symptoms of 14 days or less in the target limb.
• Ability to take oral medication and be willing to adhere to the prescribed anti- coagulant regiment.
• Occlusive DVT (confirmed by either venous duplex ultrasound or CT venogram) spanning at least one of the following:
• the iliac and/or common femoral vein. Extension into the femoral vein and/or profunda vein is allowed. OR
• the entire popliteal vein (above and below knee). Extension into the femoral vein and/or tibial veins is allowed.
• People who have scheduled or will be scheduled for treatment with the QuickClear Mechanical Thrombectomy system
• Symptomatic DVT defined as meeting at least one of the following clinical indicators:
• rVCSS Pain Score ≥2
• New edema of calf or thigh (CEAP ≥3)

You may not qualify if:

• Non-ambulatory status prior to DVT occurrence.
• Inability to lie in supine or prone under local anesthesia with moderate sedation for procedure.
• In the contralateral (non-study) leg: symptomatic DVT that, in the operating physician's opinion, will require treatment in the following 30 days.
• 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).
• 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.
• Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
• Allergy, hypersensitivity, or thrombocytopenia from heparin, iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
• History of, or active heparin-induced thrombocytopenia (HIT).
• 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).
• Active bleeding, recent (\< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
• 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.
• History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
• Active cancer with a life expectancy of \< 1 year.
• 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).
• Pregnant or breastfeeding or plans to become pregnant in the next 12 months.

Sponsors & Collaborators

• Paul J. Gagne: lead

Study Sites (6)

Vascular Care Connecticut

Darien, Connecticut, 06820, United States

Location

The Vascular Care Group

Hyannis, Massachusetts, 02601, United States

Location

The Vascular Care Group

Leominster, Massachusetts, 01453, United States

Location

The Vascular Care Group

Plymouth, Massachusetts, 02360, United States

Location

The Vascular Care Group

Wellesley, Massachusetts, 02482, United States

Location

The Vascular Care Group

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Interventions

Thrombectomy

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President, Vascular Breakthroughs, LLC

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 3, 2023
• Study Start: June 14, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (6)