Deep Vein ThrombosisNCT07622212
Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis
An observational study of Deep Vein Thrombosis, run by RenJi Hospital at 1 site in China.
Trial summary
A head-to-head comparison of two different types of percutaneous mechanical thrombectomy (PMT) - ClotTriever System versus aspiration thrombectomy (including rheolytic thrombectomy) - in patients with acute iliofemoral deep vein thrombosis (DVT) was conducted to determine whether ClotTriever System can improve… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Percutaneous mechanical thrombectomy by ClotTriever System and Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2028
- How long will I take part?
- 24 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 180
Who may be able to join
- Aged between 18 and 85 years;
- Diagnosed with acute iliofemoral venous thrombosis, with thrombosis involving at least the iliac vein and common femoral vein;
- Time from symptom onset to endovascular treatment ≤ 14 days;
- Patients undergo endovascular treatment with percutaneous mechanical thrombectomy;
- Patients sign the informed consent form.
Who cannot join
- Presence of PTS in the limb to be treated in this procedure, or a history of symptomatic DVT in the same limb within the past 2 years;
- Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
- Known allergy to heparin, low molecular weight heparin, contrast agents, etc.
- Concomitant severe pulmonary embolism with hemodynamic changes, such as hypoxia, hypotension, etc.
- Inability to tolerate endovascular treatment due to conditions such as acute systemic illness, severe dyspnea, etc.
- Concomitant severe renal insufficiency with creatinine clearance < 30 ml/min;
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- Concomitant active bleeding, severe hepatic insufficiency, bleeding tendency, etc.
- Concomitant severe anemia (hemoglobin < 8.0 mg/dL) or platelet count < 80,000/mL;
- History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm;
- Pregnant women;
- Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency, etc.) with an expected life expectancy < 24 months
- Participation in any drug or medical device clinical trial that may interfere with this study within the past 1 month;
- Patients unwilling to participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji hospital
Shanghai
Qihong Ni, +8615801900772, niqihong1989@163.com
About this study
Official title: Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis (The COMET Study)
A head-to-head comparison of two different types of percutaneous mechanical thrombectomy (PMT) - ClotTriever System versus aspiration thrombectomy (including rheolytic thrombectomy) - in patients with acute iliofemoral deep vein thrombosis (DVT) was conducted to determine whether ClotTriever System can improve thrombus clearance rate, reduce the incidence of post-thrombotic syndrome (PTS), and enhance the long-term efficacy of endovascular treatment for acute iliofemoral DVT.
Read the detailed description
Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. There is currently a lack of research on which device is optimal for thrombus removal. The aim of this study is to conduct a multicenter, observational, prospective cohort study in patients with acute iliofemoral deep vein thrombosis (DVT), performing a head-to-head comparison of two different types of mechanical thrombectomy devices - ClotTriever System versus aspiration thrombectomy (including rheolytic thrombectomy) - to determine whether ClotTriever System can improve thrombus clearance rate, reduce the incidence of post-thrombotic syndrome (PTS), and enhance the long-term efficacy of endovascular treatment for acute iliofemoral DVT.
- Conditions
- Deep Vein Thrombosis
- Being tested
- Percutaneous mechanical thrombectomy by ClotTriever System, Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy
- Keywords
- Deep venous thrombosis, Percutaneous mechanical thrombectomy, Post-thrombotic syndrome
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous mechanical thrombectomy by ClotTriever SystemProcedure or surgery
The procedure is performed via the ipsilateral popliteal vein access or the ipsilateral femoral vein access. After puncture under fluoroscopic or ultrasound guidance, a vascular sheath is inserted, systemic heparinization is administered, and a guidewire is advanced antegradely into the inferior vena cava with the assistance of a catheter to establish the access. Once the access is established, treatment is carried out using stent retriever devices. Available stent retriever devices include currently marketed options such as ClotTriever (INARI MEDICAL, USA). After thrombectomy, the thrombus removal efficacy is assessed by venography.
Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomyProcedure or surgery
The procedure is performed via the ipsilateral calf deep vein access, the ipsilateral popliteal vein access, or the ipsilateral femoral vein access. After puncture under fluoroscopic or ultrasound guidance, a vascular sheath is inserted, systemic heparinization is administered, and a guidewire is advanced antegradely into the inferior vena cava with the assistance of a catheter to establish the access. Once the access is established, treatment is carried out using mechanical aspiration thrombectomy devices. Available aspiration thrombectomy devices include currently marketed options such as the AngioJet thrombectomy catheter (Boston Scientific, USA) and the Acostream thrombectomy catheter (Acotec, China). After thrombectomy, the thrombus removal efficacy is assessed by venography.
| Study group | Role | What they receive |
|---|---|---|
| ClotTriever System group | Patients receive percutaneous mechanical thrombectomy by ClotTriever System Receives: Procedure: Percutaneous mechanical thrombectomy by ClotTriever System | |
| Aspiration thrombectomy group | Patients receive percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy Receives: Procedure: Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PTS
Assessed by the Villalta score
Measured: At 24 months
Secondary outcomes (7)
Incidence of moderate-to-severe PTS
Assessed by the Villalta score
Measured: at 6, 12, and 24 months
Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Based on clinical symptoms
Measured: at 6, 12, and 24 months
Patency rate of the ipsilateral iliofemoral vein
Assessed by color Doppler ultrasound
Measured: at 12 months and 24 months
Incidence of PTS
at 6 and 12 months
Measured: Assessed by the Villalta score
Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)
Assessed by symptoms combined with ultrasound examination in the ipsilateral limb
Measured: at 24 months
Rate of re-intervention
Assessed by documentation of clinical reintervention
Measured: at 24 months
Quality of life score
Assessed by Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire (VEINES-QOL)
Measured: at 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- 180 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Wenzhou Central Hospital, West China Hospital, Chengdu University of Traditional Chinese Medicine, First People's Hospital of Hangzhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622212
- Sponsor's protocol ID
- The COMET Study
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis (The COMET Study)
- ClinicalTrials.gov ID
- NCT07622212
- Acronym / sponsor ID
- The COMET Study
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep venous thrombosis, Percutaneous mechanical thrombectomy, Post-thrombotic syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Wenzhou Central Hospital, West China Hospital, Chengdu University of Traditional Chinese Medicine, First People's Hospital of Hangzhou
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Jun 2026 (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 head-to-head comparison of two different types of percutaneous mechanical thrombectomy (PMT) - ClotTriever System versus aspiration thrombectomy (including rheolytic thrombectomy) - in patients with acute iliofemoral deep vein thrombosis (DVT) was conducted to determine whether ClotTriever System can improve thrombus clearance rate, reduce the incidence of post-thrombotic syndrome (PTS), and enhance the long-term efficacy of endovascular treatment for acute iliofemoral DVT.
Detailed description
Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. There is currently a lack of research on which device is optimal for thrombus removal. The aim of this study is to conduct a multicenter, observational, prospective cohort study in patients with acute iliofemoral deep vein thrombosis (DVT), performing a head-to-head comparison of two different types of mechanical thrombectomy devices - ClotTriever System versus aspiration thrombectomy (including rheolytic thrombectomy) - to determine whether ClotTriever System can improve thrombus clearance rate, reduce the incidence of post-thrombotic syndrome (PTS), and enhance the long-term efficacy of endovascular treatment for acute iliofemoral DVT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ClotTriever System group | – | Procedure: Percutaneous mechanical thrombectomy by ClotTriever SystemPatients receive percutaneous mechanical thrombectomy by ClotTriever System |
| Aspiration thrombectomy group | – | Procedure: Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomyPatients receive percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 180
Key inclusion criteria (5 listed)
- Aged between 18 and 85 years;
- Diagnosed with acute iliofemoral venous thrombosis, with thrombosis involving at least the iliac vein and common femoral vein;
- Time from symptom onset to endovascular treatment ≤ 14 days;
- Patients undergo endovascular treatment with percutaneous mechanical thrombectomy;
- Patients sign the informed consent form.
Key exclusion criteria (13 listed)
- Presence of PTS in the limb to be treated in this procedure, or a history of symptomatic DVT in the same limb within the past 2 years;
- Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
- Known allergy to heparin, low molecular weight heparin, contrast agents, etc.
- Concomitant severe pulmonary embolism with hemodynamic changes, such as hypoxia, hypotension, etc.
- Inability to tolerate endovascular treatment due to conditions such as acute systemic illness, severe dyspnea, etc.
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 |
|---|---|---|
| Percutaneous mechanical thrombectomy by ClotTriever SystemThe procedure is performed via the ipsilateral popliteal vein access or the ipsilateral femoral vein access. After puncture under fluoroscopic or ultrasound guidance, a vascular sheath is inserted, systemic heparinization is administered, and a guidewire is advanced antegradely into the inferior vena cava with the assistance of a catheter to establish the access. Once the access is established, treatment is carried out using stent retriever devices. Available stent retriever devices include currently marketed options such as ClotTriever (INARI MEDICAL, USA). After thrombectomy, the thrombus removal efficacy is assessed by venography. | Procedure or surgery | ClotTriever System group |
| Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomyThe procedure is performed via the ipsilateral calf deep vein access, the ipsilateral popliteal vein access, or the ipsilateral femoral vein access. After puncture under fluoroscopic or ultrasound guidance, a vascular sheath is inserted, systemic heparinization is administered, and a guidewire is advanced antegradely into the inferior vena cava with the assistance of a catheter to establish the access. Once the access is established, treatment is carried out using mechanical aspiration thrombectomy devices. Available aspiration thrombectomy devices include currently marketed options such as the AngioJet thrombectomy catheter (Boston Scientific, USA) and the Acostream thrombectomy catheter (Acotec, China). After thrombectomy, the thrombus removal efficacy is assessed by venography. | Procedure or surgery | Aspiration thrombectomy group |
Primary outcome
Incidence of PTS
Time frame: At 24 months
Assessed by the Villalta score
7 secondary outcomes
Incidence of moderate-to-severe PTS
Time frame: at 6, 12, and 24 months
Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Time frame: at 6, 12, and 24 months
Patency rate of the ipsilateral iliofemoral vein
Time frame: at 12 months and 24 months
Incidence of PTS
Time frame: Assessed by the Villalta score
Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)
Time frame: at 24 months
Rate of re-intervention
Time frame: at 24 months
Quality of life score
Time frame: at 6, 12, and 24 months
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by RenJi Hospital at 1 site in China.
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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Qihong Ni (+8615801900772, niqihong1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PTS (time frame: At 24 months). 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 3 Jun 2026.