Surgical treatment for acute severe venous thrombosis and edema of the left lower extremity

Does combined catheter-directed thrombolysis after mechanical thrombectomy reduce the risk of post-thrombotic syndrome in acute left iliofemoral venous thrombosis?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN69393729

Enrollment

298

Registered

2025-10-12

Start date

2023-11-29

Completion date

Unknown

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombus debulking therapy for patients with iliac vein compression combined with deep vein thrombosis. Circulatory System

Interventions

Patients who meet the inclusion and exclusion criteria will be randomly assigned using a computer program to the Pharmacomechanical Thrombectomy (PMT) group or the PMT+Catheter-Directed Thrombolysis

specifically, a thrombolytic catheter will be placed at the center of the thrombus, followed by continuous local infusion of urokinase and heparin.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years 2. Definitively diagnosed with iliofemoral venous thrombosis of the left lower extremity by color Doppler ultrasound 3. Time from symptom onset to initiation of treatment was less than 14 days 4. Diagnosed with LIVC by color Doppler ultrasound or CTV (CT venography)

Exclusion criteria

Exclusion criteria: 1. History of deep vein thrombosis in the left lower extremity 2. Time from symptom onset to initiation of treatment exceeds 14 days 3. Local anatomical alterations of the iliac vein, such as lumbar vertebral developmental anomalies, abdominal or pelvic adhesions, space-occupying lesions, or retroperitoneal pathology

Design outcomes

Primary

Measure	Time frame
Complications measured using the Villalta score and the revised Venous Clinical Severity Score (r-VCSS) at 2 years	—

Secondary

Measure	Time frame
1. Duration of surgery measured using patient records 2. Duration of bed rest measured using patient records 3. Perioperative blood loss (in milliliters), quantitatively measured in mL, measured using patient records 4. Percentage (%) of bleeding events during the surgical and thrombolytic periods measured using patient records 5. Incidence rate of intraoperative complications (%): the percentage (%) of patients experiencing any intraoperative complication measured using patient records during the procedure 6. Immediate thrombus debulking outcome measured using the venous luminal patency score at the end of the intraoperative debulking procedure 7. Incidence of post-thrombotic syndrome (PTS) measured periodically using the Villalta score during the 2-year follow-up period 8. Quality of life measured periodically using the revised Venous Clinical Severity Score (r-VCSS) during the 2-year follow-up period 9. Reflux of the femoral vein valves, measured by lower extremity venous Doppler ultrasound during regular follow-up visits within 2 years 10. Recurrence of lower extremity venous thrombosis or iliac vein occlusion, measured by lower extremity venous Doppler ultrasound during regular follow-up visits within 2 years 11. Cost-effectiveness measured using hospitalization costs within 30 days postoperatively	—

Measure

Time frame

1. Duration of surgery measured using patient records 2. Duration of bed rest measured using patient records 3. Perioperative blood loss (in milliliters), quantitatively measured in mL, measured using patient records 4. Percentage (%) of bleeding events during the surgical and thrombolytic periods measured using patient records 5. Incidence rate of intraoperative complications (%): the percentage (%) of patients experiencing any intraoperative complication measured using patient records during the procedure 6. Immediate thrombus debulking outcome measured using the venous luminal patency score at the end of the intraoperative debulking procedure 7. Incidence of post-thrombotic syndrome (PTS) measured periodically using the Villalta score during the 2-year follow-up period 8. Quality of life measured periodically using the revised Venous Clinical Severity Score (r-VCSS) during the 2-year follow-up period 9. Reflux of the femoral vein valves, measured by lower extremity venous Doppler ultrasound during regular follow-up visits within 2 years 10. Recurrence of lower extremity venous thrombosis or iliac vein occlusion, measured by lower extremity venous Doppler ultrasound during regular follow-up visits within 2 years 11. Cost-effectiveness measured using hospitalization costs within 30 days postoperatively

—

Countries

China

Contacts

Public ContactDafang Liu

380693113@qq.com+86 18811792728

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026