Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis

Recruiting

• Conditions: Deep Vein Thrombosis
• Interventions: Procedure: Percutaneous mechanical thrombectomy (PMT) by the modified approach; Procedure: Percutaneous mechanical thrombectomy (PMT) by the traditional approach

• Registration Number: NCT06124768
• Lead Sponsor: RenJi Hospital

Brief Summary

The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for mixed type deep venous thrombosis (DVT), and determine whether it can achieve similar therapeutic effects as central type 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. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach for mixed type DVT, and determine whether it can achieve similar therapeutic effects as central type DVT. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Age between 18-85 years old;
2. Acute DVT occurred no more than 14 days since the onset of disease;
3. DVT treated by percutaneous mechanical thrombectomy
4. Informed consent signed by patients.

Exclusion Criteria

1. Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
2. Women during pregnancy and lactation;
3. Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<6 months);
4. Patients who are unable or unwilling to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mixed type DVT treated by PMT through the modified access	Percutaneous mechanical thrombectomy (PMT) by the modified approach	Anterograde venography shows patients with mixed type DVT. PMT is performed via ipsilateral distal calf venous access or contralateral femoral access.
Mixed type DVT treated by PMT through the traditional access	Percutaneous mechanical thrombectomy (PMT) by the traditional approach	Anterograde venography shows patients with mixed type DVT. PMT is performed via ipsilateral popliteal venous access.
Central type DVT treated by PMT	Percutaneous mechanical thrombectomy (PMT) by the traditional approach	Anterograde venography shows patients with central type DVT. PMT is performed via any access, such as ipsilateral femoral venous access or ipsilateral popliteal venous access.

Primary Outcome Measures

Name	Time	Method
Incidence of post-thrombotic syndrome	24-month	Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
Immediate patency rate	Immediately after lonely percutaneous mechanical thrombectomy	Percentage of patency rate immediately after lonely percutaneous mechanical thrombectomy

Secondary Outcome Measures

Name	Time	Method
Patency rate of lower limb vein	24-month	Percentage of patency rate of lower limb vein evaluated by ultrasound
Rate of catheter-directed thrombolysis	Immediately after interventional surgery	Percentage of catheter-directed thrombolysis after mechanical thrombectomy
Total dosage of urokinase	Immediately after interventional surgery	Total dosage measured by units of urokinase used for procedure
Incidence of post-thrombotic syndrome	12-month	Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
Re-intervention rate	24-month	Percentage of re-intervention rate for the same limb
Total time of interventional surgery	Immediately after interventional surgery	Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China