Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis

NCT07622212 | Recruiting DMC

• 1 other identifier: The COMET Study
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Deep venous thrombosis; Percutaneous mechanical thrombectomy; Post-thrombotic syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of PTS

  Assessed by the Villalta score

  At 24 months

Secondary Outcomes (7)

• Incidence of moderate-to-severe PTS

  at 6, 12, and 24 months

• Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)

  at 6, 12, and 24 months

• Patency rate of the ipsilateral iliofemoral vein

  at 12 months and 24 months

• Incidence of PTS

  Assessed by the Villalta score

• Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)

  at 24 months

Other Outcomes (4)

• Incidence of major bleeding

  at 24 months

• Incidence of symptomatic Pulmonary Embolism (PE)

  at 24 months

• Incidence of symptomatic Venous Thromboembolism (VTE)

  at 24 months

Study Arms (2)

ClotTriever System group

Patients receive percutaneous mechanical thrombectomy by ClotTriever System

Procedure: Percutaneous mechanical thrombectomy by ClotTriever System

Aspiration thrombectomy group

Patients receive percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy

Procedure: Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy

Interventions

Percutaneous mechanical thrombectomy by ClotTriever System PROCEDURE

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.

ClotTriever System group

Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy PROCEDURE

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.

Aspiration thrombectomy group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

180

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Changhai Hospital: collaborator
• West China Hospital: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• First People's Hospital of Hangzhou: collaborator
• RenJi Hospital: lead
• Wenzhou Central Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator

Study Sites (1)

Renji hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Central Study Contacts

Qihong Ni

CONTACT

+8615801900772; niqihong1989@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 3, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)