Clinical trial NCT05928221: Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Deep Venous Thrombosis of Ileofemoral Vein
Lead sponsor: Vascular Care CT, PLLC
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Primary Device Effectiveness
timeFrame: Immediately after procedure
measure: Change in revised Venous Clinical Severity Score (rVCSS)
timeFrame: 30 days post index procedure
measure: Change in Villalta Score
timeFrame: 30 Days Post Index Procedure
measure: Change in EuroQol-5 Dimension (EQ-5D) Score
timeFrame: 30 Days Post Index Procedure
measure: Primary Safety Endpoint
timeFrame: 12 months post index procedure
Secondary outcomes:
measure: Total blood loss during procedure
timeFrame: immediately after index procedure
measure: Age of Deep Vein occlusive disease
timeFrame: immediately after the procedure
measure: Health Economics
timeFrame: 3 months post index procedure
measure: Primary patency
timeFrame: 12 months post index procedure
measure: Assisted primary patency
timeFrame: 12 months post index procedure
measure: Change in revised Venous Clinical Severity Score (rVCSS)
timeFrame: 12 months post index procedure
measure: Overall patient safety
timeFrame: 12 months post procedure
measure: Change in Villalta Score
timeFrame: 12 months post index procedure
measure: Change in EuroQol-5 Dimension (EQ-5D) Score
timeFrame: 12 months post index procedure
Other outcomes:
Locations:
city: Darien
country: United States
facility: Vascular Care Connecticut
state: Connecticut
city: Hyannis
country: United States
facility: The Vascular Care Group
state: Massachusetts
city: Leominster
country: United States
facility: The Vascular Care Group
state: Massachusetts
city: Plymouth
country: United States
facility: The Vascular Care Group
state: Massachusetts
city: Wellesley
country: United States
facility: The Vascular Care Group
state: Massachusetts
city: Worcester
country: United States
facility: The Vascular Care Group
state: Massachusetts
Study officials:
References: