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Enrolling by invitation NCT05588284

Preservation of Venous Valvular Function After PMT for Acute DVT

No phase Interventional Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AngioJet device, anticoagulation alone.
Who it may be relevant to
Registry conditions: Acute Deep Venous Thrombosis of Femoral Vein (Disorder). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Endovascular Thrombectomy for Femoral Popliteal Vein Thrombosis on Venous Valve Function Maintenance: a Single-center, Single-arm Prospective Observational Study

Overview

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.

Interventions

  • Device AngioJet device
    A device can be used for thrombus aspiration and thrombolysis.
  • Other anticoagulation alone
    a medicine for anticoagulation therapy

Primary outcome measures

  • Valvular reflux prevalence [Time frame: at 12 months after procedure]
Secondary outcome measures (2)
  • Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) [Time frame: at 6, 12 and 24 months after procedure]
  • Patency rate of femopopliteal vein and iliofemoral vein [Time frame: at 6, 12 and 24 months after procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 7 centers
  • Chuzhou People's Hospital — Chuzhou
  • Center hospital of Putu — Shanghai
  • Central Hospital of Songjiang — Shanghai
  • North Branch of Shanghai Ninth People's Hospital — Shanghai
  • Shanghai Ninth People's Hospital — Shanghai
  • Fengchen Hospital — Shanghai
  • Taizhou Municipal hospital — Taizhou

Identifiers

NCT: NCT05588284 · AAL03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗