The Study of Percutaneous Mechanical Thrombectomy Treating Acute Deep Vein Thrombosis of Lower Extremities (PROSTA)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2026
  • participants needed
    600
  • sponsor
    Chengdu University of Traditional Chinese Medicine
Updated on 26 May 2022
clot
thrombectomy
deep vein thrombosis
venous thrombosis
acute deep venous thrombosis
deep venous thrombosis of lower extremity

Summary

This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. we can obtain data on the incidence of sequelae of deep venous thrombosis after PMT, and analyze the factors that may affect the efficacy of PMT.

Description

Through inclusion and exclusion criteria, 600 patients were collected. This experiment was an observational study case series, and no control group was established. The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.Postoperative clinical follow-up was performed at 6 months, 12 months, 18 months, and 24 months. The main endpoints were the patency rate of lower extremity deep veins at 6 months after operation and the incidence of PTS (Villalta score) at 2 years after operation.

Details
Condition Pharmacomechanical Thrombolysis, Deep Vein Thrombosis
Treatment Pharmacomechanical thrombolysis, Pharmacomechanical thrombolysis
Clinical Study IdentifierNCT05356767
SponsorChengdu University of Traditional Chinese Medicine
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days);
Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein
Obtain the informed consent of all patients

Exclusion Criteria

Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis
patients who are prohibited from thrombolytic therapy
inferior vena cava compression syndrome;
Allergic to heparin, low molecular weight heparin or contrast medium
Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months
Patients who do not want to participate in this trial
Patients with poor compliance, or those who the researchers think are not suitable for selection
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