Acute Deep Venous Thrombosis of Ileofemoral VeinNCT05928221
Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System
An observational study of Acute Deep Venous Thrombosis of Ileofemoral Vein, run by Paul J. Gagne at 6 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Deep Venous Thrombosis of Ileofemoral Vein
- What is being tested?
- Thrombectomy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Jun 2023to Jul 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
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- 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.
- Thrombus of the inferior vena cava (IVC) extending at least one centimeter above the common iliac vein confluence.
- Inability to obtain venous access.
- Contraindication to Enoxaparin (e.g., Severe chronic kidney injury, allergic reaction, HIT)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Vascular Care Connecticut
Darien, Connecticut, 06820
The Vascular Care Group
Hyannis, Massachusetts, 02601
The Vascular Care Group
Leominster, Massachusetts, 01453
The Vascular Care Group
Plymouth, Massachusetts, 02360
The Vascular Care Group
Wellesley, Massachusetts, 02482
The Vascular Care Group
Worcester, Massachusetts, 01605
About this study
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)
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.
- Being tested
- Thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyDevice
Also called QuickClear Mechanical Thrombectomy system
removal of fresh soft emboli and thrombi from the vessels of the venous system
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months post index procedure
Secondary outcomes (9)
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.
Measured: 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
Measured: immediately after the procedure
Health Economics
Analysis of procedural reimbursement versus procedural cost of treatment
Measured: 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
Measured: 12 months post index procedure
Assisted primary patency
required reintervention to maintain patency
Measured: 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
Measured: 12 months post index procedure
Overall patient safety
Adverse event tracking
Measured: 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.
Measured: 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.
Measured: 12 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start14 Jun 2023
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Deep Venous Thrombosis of Ileofemoral VeinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Paul J. Gagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul J. Gagne, Vascular Care CT, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928221
- Sponsor's protocol ID
- CP-001
- Status last verified
- Feb 2026
- First submitted
- 12 Jun 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05928221
- Acronym / sponsor ID
- CP-001
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Paul J. GagneUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThrombectomyAlso: QuickClear Mechanical Thrombectomy systemremoval of fresh soft emboli and thrombi from the vessels of the venous system | Device | – |
Primary outcome
Primary Device Effectiveness
Time frame: Immediately after procedure
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
Change in revised Venous Clinical Severity Score (rVCSS)
Time frame: 30 days post index procedure
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
Change in Villalta Score
Time frame: 30 Days Post Index Procedure
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.
Change in EuroQol-5 Dimension (EQ-5D) Score
Time frame: 30 Days Post Index Procedure
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.
Primary Safety Endpoint
Time frame: 12 months post index procedure
Serious adverse event related to the device, study procedure or secondary procedure to maintain or re-establish patency
9 secondary outcomes
Total blood loss during procedure
Time frame: immediately after index procedure
Age of Deep Vein occlusive disease
Time frame: immediately after the procedure
Health Economics
Time frame: 3 months post index procedure
Primary patency
Time frame: 12 months post index procedure
Assisted primary patency
Time frame: 12 months post index procedure
Change in revised Venous Clinical Severity Score (rVCSS)
Time frame: 12 months post index procedure
Overall patient safety
Time frame: 12 months post procedure
Change in Villalta Score
Time frame: 12 months post index procedure
Change in EuroQol-5 Dimension (EQ-5D) Score
Time frame: 12 months post index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Deep Venous Thrombosis of Ileofemoral Vein, run by Paul J. Gagne at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Device Effectiveness (time frame: Immediately after procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.