RECRUITING

Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System

Conditions

Acute Deep Venous Thrombosis of Ileofemoral Vein

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2023-06-14

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05928221

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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)

Inclusion Criteria

Exclusion 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)

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)

Contacts and Locations

Study Contact

Maria Myslinski, RN

CONTACT

203-548-7860

mmyslinski@vascularbreakthroughs.com

Elizabeth Gagne, PhD

CONTACT

203-548-7860

egagne@vascularbreakthroughs.com

Study Locations (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

Collaborators and Investigators

Sponsor: Paul J. Gagne

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-14

Study Completion Date2026-03

Study Record Updates

Study Start Date2023-06-14

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Acute Deep Venous Thrombosis of Ileofemoral Vein