Preservation of Venous Valvular Function After PMT for Acute DVT

Not Applicable

• Conditions: Acute Deep Venous Thrombosis of Femoral Vein (Disorder)
• Interventions: Other: anticoagulation alone; Device: AngioJet device

• Registration Number: NCT05588284
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.

Detailed Description

All patients presenting with symptoms in the lower extremity due to the femoral venous thrombosis involving or not involving iliac and popliteal veins treated with percutaneously pharmacomechanical catheter-directed thrombolysis via AngioJet devices or anticoagulation alone were included in this study.

Study Timeline

• Study Start: 2022-06-06
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-06-06
• Study Completion: 2025-06-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with acute symptomatic proximal DVT involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in China. Patients were treated with PCDT via Zelante device (Boston Scientific).

Exclusion Criteria

• Participants were excluded if they had symptoms for more than 14 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anticoagulation alone for acute DVT	anticoagulation alone	anticoagulation alone for acute DVT
Pharmacomechanical Catheter-directed Thrombolysis for acute DVT	AngioJet device	AngioJet, Boston Scientific

Primary Outcome Measures

Name	Time	Method
Valvular reflux prevalence	at 12 months after procedure	Proportion of patients with femoral venous valve reflux at 1 year after procedure

Secondary Outcome Measures

Name	Time	Method
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)	at 6, 12 and 24 months after procedure	Patients who experienced one of the following occurrences in the index leg between the 12 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Patency rate of femopopliteal vein and iliofemoral vein	at 6, 12 and 24 months after procedure	Patients who presented with patent femopopliteal vein and iliofemoral vein

Trial Locations

Locations (7)

North Branch of Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Chuzhou People's Hospital; 🇨🇳 Chuzhou, Anhui, China

Center hospital of Putu; 🇨🇳 Shanghai, Shanghai, China

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Central Hospital of Songjiang; 🇨🇳 Shanghai, Shanghai, China

Taizhou Municipal hospital; 🇨🇳 Taizhou, Zhejiang, China

Fengchen Hospital; 🇨🇳 Shanghai, Shanghai, China